Re: Docket No. FDA-2011-N-0143, Regulatory Information Number 0910-AG64. Foreign Supplier Verification Program.
On behalf of the members of the Fresh Produce Association of the Americas (FPAA), we would like to take the opportunity to comment on the proposed Foreign Supplier Verification Program 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 Foreign Supplier Verification Program rule (FSVP 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. Also, the FSVP rule sets out a variety of options and outcomes for first-time consideration. These new provisions impact the implementation of the rules already closed for comment, so now 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.
Overview:
Issuance of Guidance and Support for Implementation Timeline
The FDA states that it intends to issue guidance to importers on implementing FSVP. This guidance should be issued in a timely manner, concurrently with the final rule to allow importers to effectively implement FSVP measures. The FPAA also supports the FDA’s proposed implementation timeline and phase-in period to allow the industry ample time to comply with a final regulation. Importers and their foreign suppliers will need adequate time to prepare for the FSVP.
FSVP Must Clarify “Comparability” Program and Fair Administration
The FPAA requests that FDA issue written criteria for the comparability program available for foreign governments in the recognized WTO languages of English, French, and Spanish. The FPAA requests that FDA focus on Mexico as a priority in working towards comparability because of the close trade relationships between the U.S. and Mexico and given that Mexico is the largest foreign supplier of fruits and vegetables to the United States. Given the complexity of the food supply, the FPAA also requests that FDA explore granting comparability for specific food sectors within a country that can demonstrate equivalent public health protection, including analyzing existing MOUs with foreign governments relating to specific commodity groups for export to the U.S.
§ 1.500 What definitions apply to this subpart
“Foreign supplier means, for an article of food, the establishment that manufactures/processes the food, raises the animal, or harvests the food that is exported to the United States without further manufacturing/processing by another establishment, except for further manufacturing/processing that consists solely of the addition of labeling or any similar activity of a de minimis nature.”
The FPAA believes there should be some clarification of de minimis activities for fresh produce. The FPAA proposed in our comments on Preventive Controls, to modify the farm definition. Our comments state: “The FPAA believes that the definition for “farm” as proposed by FDA is too limited and fails to take into account typical farm activities. The FDA defines farm as “a facility in one general physical location devoted to the growing and harvesting of crops…Washing, trimming of outer leaves of, and cooling produce are considered part of harvesting.” The definition ignores activities like waxing, sorting, culling, conveying, storing, labeling, packing, packaging, and shipping of Raw Agricultural Commodities (RACs). Atmosphere control to inhibit or promote ripening, fumigation, pest control and more are also part of storing a product. Normal handling, storing, and packing activities that do not alter the physical shape or structure of a RAC should be considered normal farm activities and should be consistent with the “farm” definition. Foreign suppliers that conduct these activities should be covered under the Produce Safety rule and not under the Preventive Controls rule.”
The FPAA strongly believes that de minimis activities for fresh produce in the FSVP should include our proposed “farm” activities as outlined above, and in our Preventive Controls
comments. Clarifying the de minimis activities for fresh produce would ensure that typical produce activities are not considered manufacturing/processing and would clarify the definition of “foreign supplier” for the FSVP rule.
“Importer”
The FDA requests comments on whether there should be modified FSVP requirements when importing food from entities under the same corporate ownership. The FPAA supports the position that all importers conduct foreign supplier verification, regardless of corporate ownership.
“Manufacturing/processing means making food from one or more ingredients, or synthesizing, preparing, treating, modifying, or manipulating food, including food crops or ingredients. Examples of manufacturing/processing activities are cutting, peeling, trimming, washing, waxing, eviscerating, rendering, cooking, baking, freezing, cooling, pasteurizing, homogenizing, mixing, formulating, bottling, milling, grinding, extracting juice, distilling, labeling, or packaging. For farms and farm mixed-type facilities, manufacturing/processing does not include activities that are part of harvesting, packing, or holding.”
The definition of manufacturing/processing as outlined in the FSVP proposed rule would complicate the definition of “foreign supplier” and go against the intent of the FSVP as we understand it. The FSVP is designed to require importers to perform risk-based verification of foreign suppliers, which for members of the FPAA includes growers. However, under the FSVP proposed definition of “manufacturing/processing”, by sending product to a packing facility that washes and waxes produce, the foreign supplier becomes the packing facility because the act of washing and waxing the product is considered manufacturing.
The FPAA again reiterates our strong support of having a separate definition of de minimis activity for fresh produce that includes the activities we listed above in the discussion of the “foreign supplier” definition.
“Qualified individual means a person who has the necessary education, training, and experience to perform the activities needed to meet the requirements of this subpart… a qualified individual must have successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to develop and implement a food safety system.”
The FPAA supports the definition of “qualified Individual” as written in the FSVP proposed rule.
The FDA requests comment on whether, at some future date, importers should no longer be permitted to rely on third-party auditors unless accredited under section 808. The FDA also requests comment on ways an importer might rely on the actions of a foreign government
employee in complying with FSVP requirements. The FPAA supports the use of foreign government auditing bodies. The FPAA does not support the mandatory use of auditors that have been accredited by FDA-recognized accreditation bodies, however. The use of audits is a worldwide industry practice. Including audits as one possible verification step to comply with FSVP gives the FDA and the industry a mechanism to leverage this practice. By limiting audits for FSVP to only Certified Auditors under section 808, the FDA would significantly limit the availability of this important verification tool.
There are over 190 countries in the world. Because FDA has not established or implemented a third-party auditing program, and because it is unclear if there will be sufficient Accreditation Bodies or accredited auditors to cover food operations across the world, the FPAA strongly believes that limiting audits to only FDA accredited auditors would potentially harm food safety efforts.
FDA is creating the Third Party Accreditation rule to alleviate the shortages of FDA inspectors, and they are mandated in the case of the VQIP program and in certain high risk cases as determined by the Secretary. Mandating audits by FDA accredited auditors for FSVP goes beyond the scope of the law, and could significantly hamper businesses from efficiently obtaining audits of their operations. By limiting the industry to only FDA accredited third-party auditors, the agency would again be creating the potential of manpower shortages without addressing that problem. By mandating the requirement of FDA accredited audits, FDA could potentially block companies from shipping to the United States because of possible shortages of accredited third-party auditors.
It is also reasonable to expect that some auditors might not choose to be accredited by the FDA third-party system due to legitimate business choices, such as the cost associated with the process or how it fits into their business model. These auditors should still be considered qualified individuals for the purposes of FSVP, and as such, should remain one of the several tools available to importers in their foreign supplier verification activities.
In addition, an employee of a foreign government’s food safety authority could provide support and services to a foreign supplier in the form of audits, development of food safety programs, and other outreach and extension types of activities. In some of these instances, an employee of a foreign government could be used by an importer as part of their verification activities under FSVP. That foreign government should not have to be accredited under FDA’s third-party accreditation process and should also be recognized as a “qualified individual” for the purposes of FSVP.
“Very small foreign supplier. Very small importer”
The FPAA believes the definitions for both “very small foreign supplier” and “very small importer” should be based on worldwide sales. Determining which products would be destined for the United States, for other countries, or for the company’s domestic market would be difficult to track. Notwithstanding our position on the aforementioned definitions, the FPAA does not support an exemption or modified FSVP requirement based on the size of a company.
§ 1.502 What foreign supplier verification program (FSVP) must I have?
The FDA states, “…for each food you import, you must develop, maintain, and follow an FSVP that provides adequate assurances that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 (regarding hazard analysis and risk-based preventive controls for certain foods) or 419 (regarding standards for produce safety), if either is applicable, and is producing the food in compliance with sections 402 (regarding adulteration) and 403(w) (regarding misbranding with respect to labeling for the presence of major food allergens) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350g, 350h, 342, and 343(w)).”
The FPAA requests clarification as to how the FDA will acknowledge processes and procedures that “provide the same level of public health protection”.
The FPAA also requests clarification as to what the interpretation of “for each food you import, you must develop, maintain, and follow an FSVP.” For example, an importer could have a foreign supplier that grows a commodity group, like different varieties of summer squash or different varieties of table grapes, and the varieties of one commodity group are grown at the same operation with the same employees using the same methods and packing facilities. The FPAA believes that a similar commodity group, such as yellow straight-neck squash, yellow crooked-neck squash, zucchini, and gray squash, should be considered under one FSVP. Similar comparisons can be made to different varieties of table grapes, or certain tree fruits. Additionally, would the same commodity packaged in different pack styles be considered one food or would they require different FSVPs? The FPAA believes that produce grown, harvested, and packed under the same conditions should be aggregated under one verification program. This would make sense scientifically for purposes of food safety. It would also reduce the economic and personnel burden on both the supplier and the regulatory agencies.
§ 1.504 What review of a food and foreign supplier's compliance status must I conduct?
“Before importing a food from a foreign supplier, you must review the compliance status of the food and the foreign supplier, including whether they are the subject of an FDA warning letter, import alert, or requirement for certification issued under section 801(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(q)) relating to the safety of the food, to determine whether it would be appropriate to import the food from the foreign supplier. You must document this review. You must continue to monitor and document the compliance status as long as you import the food from the foreign supplier.”
The FPAA supports the proposal that an importer would review the compliance status of the food and the foreign supplier to determine if there are any FDA actions against the food or supplier. We believe the proposal as written, is a sufficient requirement. Additionally, the FPAA believes that in order for this step to be effective, the FDA website must be kept current with the latest warning letters, import alerts, and requirements that impact foreign suppliers.
The FDA requests feedback on whether an importer should also have to conduct a check on the foreign supplier’s compliance standing with the food safety authority of the country in which it is located. The FPAA believes this exceeds the scope of FDA and of the FSMA. The information may not be readily available to an importer from the foreign country’s food safety authority. Foreign language translation, the robustness of a foreign food safety authority’s website and information sharing processes, and accessibility of the authorities could all delay an importer’s ability to obtain the compliance status in a foreign country. Additionally, not all countries have the same standards. For example, in the E.U., GMO’s are listed as a food safety hazard. Should that food, considered a hazard in the E.U., be denied entry into the U.S.?
§ 1.505 What hazard analysis must I conduct?
The FPAA is concerned that a hazard analysis for chemical, physical, and radiological hazards is not a requirement under the Produce Rule but will be required by importers of RACs under FSVP. The additional requirement for imported product only implies that these hazards are only present in RAC operations outside of the United States, which is not based on science or reality.
The FPAA believes that the importer should be required to verify that the foreign supplier is in compliance with FDA regulations through a FSVP without requiring that an importer, agent of the importer, or foreign supplier conduct an additional hazard analysis for chemical, physical, or radiological hazards, which goes beyond the scope of the Produce Rule. In addition to placing an additional requirement on importers for imported products, the FPAA also believes that due to the seasonality and production windows of many crops, it would be very difficult for an importer to visit and conduct their own hazard analysis for physical, chemical, and radiological hazards in advance of purchasing the fresh produce or entering into a marketing agreement with a grower. In addition, the FPAA believes that the processes and procedures of a robust food safety plan would lend themselves to minimizing chemical, physical, and radiological hazards as well. Requiring an importer to conduct their own hazard analysis in these instances would greatly restrict business agreements between importers and foreign suppliers and would place additional requirements on imported produce.
§ 1505 (c) Hazard Evaluation
The FDA lists 9 items that an importer must consider in conducting a hazard evaluation of a foreign supplier. Further, in §1505(e), importers of RACs are exempt from conducting a hazard analysis for microbiological risks. The FPAA supports limiting the requirements for importers of RACs to verifying that foreign suppliers are in compliance with relevant FDA regulations that would fall under the scope of the Produce Safety rule without expanding an importer’s requirements to conduct a hazard analysis for microbiological risks or other procedures beyond the Produce Safety rule. The FPAA believes that the 9 items outlined by the FDA in §1505(c) are addressed in the proposed Produce Safety rule for minimizing microbial contamination. Further, the FPAA believes that required hazard analysis in §1505(c)(2) for “the condition, function, and design of the foreign supplier’s establishment and equipment” would not allow for importers to evaluate this hazard by reviewing a foreign supplier’s food safety plans and records, and would, in fact, require onsite review and analysis. While §1506 allows for an importer to conduct verification through a variety of procedures, including sampling and reviews of food safety plans, the analysis of a supplier’s equipment and facilities would mandate an onsite audit
by the importer. Due to the seasonality and production windows of many crops, it would be difficult for an importer to visit and conduct their own hazard analysis of equipment and facilities, and the FPAA believes these issues are addressed in the Produce Safety rule.
§ 1.506 What foreign supplier verification and related activities must I conduct?
(e) Hazards controlled by you (importer) and (f) Hazards controlled by your customers. “…you must document that your customer controls the hazard by obtaining written assurance, at least annually, from the customer that is has established and is following procedures (identified in the written assurance) that adequately controls the hazard.”
The FPAA believes that a mechanism must be developed for imported goods when the hazard will be controlled by the importer or by the importer’s customer. There are situations where raw agriculture commodities are imported strictly for the purposes of being processed in a cooking and canning operation. The FDA has experience in this issue with fresh jalapenos that are de-stemmed in Mexico and imported raw but are destined solely for processing.
One mechanism that could provide an alternative for imported commodities where the hazard is being controlled by the importer or customer for processed foods would be the U.S. Department of Agriculture’s Importer Exempt Commodity Form (FV-6). The form would accompany a shipment upon entry and would designate the product is destined for processing. This could prevent a product being refused entry if there was the presence of a hazard that would be controlled by the importer or customer.
§ 1.506(g) Hazard Controlled or Verified by the Foreign Supplier
The FPAA supports Option 2 as outlined under 1.506(g) Hazards Controlled or Verified by the Foreign Supplier and Option 2 in 1.506(h) Raw Agriculture Commodity Options. We also believe that the FSMA statute supports Option 2 for verification activities.
A final rule that would mandate audits for all suppliers does not take into account new operations that will be severely impacted. For example, a new blueberry operation can be in production for a very short window of 3 to 4 weeks. Under many audit schemes, a grower must be in production for at least a month, with another week or more needed to receive audit results. Before an audit is conducted and results are shared with the grower, the production window has already ended, effectively prohibiting a new operation from accessing the U.S. market. There are other verification activities that would have been effective in order for an importer to work with this type of company, but Option 1 would have effectively shut that operation out of the U.S. market.
Audits are indispensable to the produce industry; however, audits should not be required in every situation. Option 2, which would allow importers to determine the appropriate verification activities to apply for suppliers, is the most flexible approach. It is aligned with current industry practices, and would allow importers to tailor their programs based on risk. Audits do not ensure safe food. They ensure that specified processes are being conducted during the course of the audit.
While most of our members will continue to conduct audits as part of a comprehensive food safety program, the FPAA has concerns with Option 1, which proposes mandatory audits. The FPAA firmly supports robust food safety controls, which incorporate a variety of strategies and activities, but we do not believe that mandatory audits are a practical solution nor are they a substitute for effective food safety programs. An overreliance on audits can give a false sense of security, and again, they are no substitute for robust food safety program. Food safety audits are a valuable tool but only one of many tools that are equally important in a supplier’s food safety programs.
The FPAA also supports Option 2 because there is a lack of sufficient auditors to make Option 1 feasible. In addition, auditor calibration will become a serious obstacle under Option 1. It is difficult now to calibrate small audit pools for companies in the U.S. alone. On a global scale and for the number of auditors needed under Option 1, efficient auditor calibration would be difficult.
There are other situations where audits may not be available in a timely manner. Table grapes from northern Sonora on average begin production around May 8. However, weather or other factors could push production back by a week or more. If a grower misses an audit date, they may not get an audit date for another month or two months, which already approaches the end of the production cycle. There are instances where individual auditors become unavailable due to illness, scheduling, or other reasons, and this could also delay audit dates.
Requiring an audit in effect excludes the first year of production for any new grower and may prevent new companies from entering into business in the first place. This is unreasonable and unnecessary and not required for domestic operations. Additionally, it may place a significant economic burden on many foreign suppliers and may be viewed as a trade barrier. Again, audits do not ensure safe food. They ensure that specified processes are being followed during the course of the audit. They are an important tool in certain situations but cannot replace a robust food safety program.
Under Option 2: §1.506(g)(1)(i) Periodic onsite auditing:
The FPAA supports the FDA’s inclusion in the accreditation of third-party auditor proposed regulation that importers can use FDA accredited third-parties for compliance with FSVP. The FPAA also supports the proposal that certification of food under section 801(q) required as a condition of granting admission to for certain high-risk foods be allowed as a valid audit for FSVP purposes. Audits conducted for the purpose of enrolling in the Voluntary Qualified Importer Program should also satisfy audit measures under the verification methods for FSVP. Aligning audit requirements, industry resources, and government resources are all crucial in ensuring that resources are used effectively to enhance food safety.
However, importers should be able to use non-accredited auditors for FSVP verification audits that do not participate in FDA’s Third Party Accreditation activities. As previously discussed,
the FPAA does not support limiting foreign suppliers to only using auditors accredited under FDA’s Third-Party Accreditation program.
§1.506(g)(1)(ii) Periodic or lot-by-lot sampling and testing of the food
Reporting of microbiological sampling for RAC’s under this section should follow the Reportable Food Registry rules. However, under the third party accreditation rule, if the importer conducts a voluntary microbiological sample through an accredited third party, the audit results must go directly to FDA, potentially triggering DWPE, even if the food was still in the chain of custody of the foreign supplier. The result of this requirement will be that fewer voluntary audits will be conducted, reducing food safety cooperation.
§1.506 (g)(3) Substitution of inspection by FDA or an officially recognized or equivalent food safety authority.
The FPAA supports 1.506(g)(3) (of Option 2) that states that an inspection by FDA or an officially recognized or equivalent food safety authority could be relied upon by an importer as part of their verification steps.
In addition, FDA conducts verification and reviews procedures for foreign firms for determining admissibility into the United States. For example, the FDA and the Government of Mexico have a Memorandum of Understanding on the importation of cantaloupes. This type of intergovernmental agreement should be considered a reliable verification process for importers working with cantaloupe growers on FDA’s “green list” for cantaloupes. Existing and future intergovernmental agreements should be recognized as a verification activity. Additionally, the FDA conducts document reviews and food safety procedure analysis for firms that are subject to DWPE in order to be removed from DWPE. FDA review of internal documents, processes, and procedures for removal from DWPE should be considered an “other appropriate measure.”
§1.507 What investigations and corrective actions must I conduct under my FSVP?
In 1.507(b) and 1.507(c), FDA proposes that the importer must investigate the cause or causes of adulteration or misbranding and take appropriate corrective actions if it determines that one of its foreign suppliers did not produce the food in compliance with processes and procedures that provide the same level of public health protection as required under the FD&C.
FPAA agrees that the importer has a role in investigating the cause or causes of adulteration or misbranding, and in taking appropriate corrective actions. FPAA believes that such actions do not necessarily require a physical visit to the foreign supplier, but could include actions such as written and/or verbal inquiries, as well as written and/or verbal instructions toward corrective actions. In an instance where a foreign supplier is linked to possible adulteration of fresh produce, and in which the FDA has placed the foreign supplier on DWPE and requires certain steps be taken by the foreign supplier to be removed from DWPE, such a process should constitute corrective action on the importer’s part.
§1.510 How must I maintain records of my FSVP?
The FPAA supports maintaining records for a period of at least 2 years as that falls in line with other governmental recordkeeping requirements. However, the FPAA does not believe that it is necessary to require all records be kept in English. Expenditures for translation could be staggering for documents that could only be held as records and never needed. An importer should be able to have records translated in a reasonable amount of time as deemed necessary.
The FSVP proposal as written would place significant new documentation and recordkeeping burdens on importers and suppliers by requiring English translation of all documents required. Translation of this documentation, including audits, would be a major expense incurred by importers and foreign suppliers. In addition, audit results and analysis are more meaningful for a company when the results are discussed and provided in that company’s native language.
§1.512 What FSVP may I have if I am a very small importer or I am importing from a very small foreign supplier?
As stated in our discussion of the definitions of very small foreign suppliers and very small importers, the FPAA does not support modifications or exemptions to the FSVP requirements based on a company’s size.
§1.513 What FSVP may I have if I am importing a food from a country with an officially recognized or equivalent food safety system?
The FPAA supports this section in general and believes that food imported from a country whose food safety systems have been formally recognized by FDA as comparable should be considered compliant under FSVP requirements. We further propose that FDA recognizes as equivalent those commodities that are covered under existing MOUs between the FDA and a foreign government.
As previously stated, the FPAA requests that FDA issue written criteria for the comparability program available for foreign governments in the recognized WTO languages of English, French, and Spanish. The FPAA requests that FDA focus on Mexico as a priority in working towards comparability because of the close trade relationships between the U.S. and Mexico and given that Mexico is the largest foreign supplier of fruits and vegetables to the United States.
§1.514 What are some consequences of failing to comply with the requirements of this subpart?
There are so many new rules, paperwork and recordkeeping requirements on the importer that finding technical infractions may be very easy to do. Any technical infraction will allow a FDA official to withdraw the registration of the importer and stop all importations. Thus, with no food safety risk or fault of the grower or meaningful infraction by the importer, FDA could impose a penalty. This will chill any cooperative food safety environment. There needs to be a well-defined appeals process to quickly arbitrate any disputes regarding the requirements of the subpart. Furthermore, FDA should measure any infractions based on the likelihood of potential food safety problems or if an infraction is a minor technical infraction based on paperwork or recordkeeping procedures.
Thank you again for the opportunity to comment on the proposed FSVP regulations. Please do not hesitate to contact me with any additional questions.
Sincerely,
Lance Jungmeyer
President
Fresh Produce Association of the Americas
Source: Fresh Produce Association of the Americas
