Today FDA released a draft guidance to provide information about what actions by a foreign food establishment or government are considered a refusal of inspection. “FSMA gives the U.S. Food and Drug Administration the authority to refuse imported food admission into the United States if the agency is not permitted to inspect the foreign establishment that produced the food,” FDA stated in a release.
The 12-page draft guidance, Refusal of Inspection by a Foreign Food Establishment or Foreign Government, outlines how the agency goes about scheduling inspections of foreign establishments (despite the fact that FDA is not required to pre-announce inspections), the inspection activities themselves, and very detailed examples of what it considers an inspection refusal from a facility (from a lack of communication with FDA that delays the agency’s request to schedule an inspection, to preventing an FDA investigator from entering a facility, when a facility sends staff home and tells FDA that it is not producing product).
The draft also details what it considers to be refusal of inspection by a foreign government. Some of the actions include preventing FDA investigators from entering the country or asks them to leave the country before an inspection is scheduled; and limiting access to areas of the facility that manufacturing, processing and packaging occurs; and limiting investigators from collecting samples for analysis.
If either a foreign food establishment or a foreign government refuses an inspection, they will stay on the agency’s Red List of Import Alert 99-32 until FDA is able to schedule and conduct an inspection.
As all the FSMA rules move to enforcement status, food companies must prepare to best respond to requirements and, correspondingly, to develop required programs such as the Foreign Supplier Verification Program (FSVP) rule. The FSVP requires impacted companies to document specific verification steps to satisfy regulations and meet foreign-supplied shipment information requirements. These requirements took effect on May 30, 2017 for companies importing certain food products to the United States.
How much do you know about FSVP? Test your smarts by taking the FSMA FSVP IQ Test here Ultimately, the purpose of the FSVP is to document the shipping paperwork necessary to provide evidence and verification that a foreign supplier’s food-grade product shipped to a U.S. customer meets the requirements of FSMA. A company’s FSVP may include providing an additional level of evidence that the foreign company distributes safe foreign-supplied food products to the United States, the qualification of these suppliers, verification of supplier and shipment information, and records to verify the shipment of all imported food under FSMA and food safety plans. This information provides the U.S. customer receiving the product necessary proof of compliance and a record that the foreign-supplied material meets imported food product requirements.
Self-Diagnostic Assessment Tool
The following self-diagnostic assessment tool can help organizations better determine their current state of planning when it comes to implementing and managing FSMA FSVP requirements. To complete your own assessment, review and compare your programs to the questions in Table I.
Companies must have the appropriate systems in place to comply with FSMA FSVP requirements or face possible willful non-conformance, which can include fines and criminal penalties under FDA enforcement. The questions above will help companies identify areas to consider regarding their FSVP programs. Kestrel can also help answer questions, provide input on solutions, discuss how to better manage all your food safety requirements, and change “No” responses into “Yes” responses that promote best practices for FSMA and food safety compliance.
Yesterday Sonny Perdue, U.S. Secretary of Agriculture announced that the USDA would be halting all imports of fresh beef from Brazil. The USDA has been inspecting all of the meat products entering the United States from Brazil since March, and has refused entry to 11% of fresh beef products. According to an agency press release, this figure is “substantially higher than the rejection rate of 1% of shipments from the rest of the world”. The increased inspection has resulted in refusal of entry to about 1.9 million pounds of Brazilian beef products over concerns related to public health, sanitary conditions and animal health.
“Although international trade is an important part of what we do at USDA, and Brazil has long been one of our partners, my first priority is to protect American consumers. That’s what we’ve done by halting the import of Brazilian fresh beef.” – Sonny Perdue, U.S. Secretary of Agriculture
The USDA is suspending shipments until the Brazilian Ministry of Agriculture takes corrective action that the agency finds adequate.
On Wednesday FDA launched a website where organizations can apply to be recognized as a third-party accreditation body. The certifications are used either to establish eligibility to participate in the voluntary qualified importer program, which provides expedited review and entry of food for eligible participants, or in circumstances in which FDA requires an imported food to be certified to keep potentially harmful food from entering the United States.
“Accredited Third-Party Certification is a voluntary program in which FDA recognizes ‘accreditation bodies’ that will have the responsibility of accrediting third-party ‘certification bodies’. The certification bodies will conduct food safety audits and issue certifications of foreign food facilities.” – FDA
Today U.S. Secretary of Agriculture Sonny Perdue praised a trade agreement reached between the United States and China that is allowing the return of American beef to the Chinese market for the first time in 13 years. The ban has been in place since 2003 following a case of mad cow disease. However, China’s domestic cattle population is not keeping up with the increased consumer demand.
“This is tremendous news for the American beef industry, the agriculture community, and the U.S. economy in general. We will once again have access to the enormous Chinese market, with a strong and growing middle class, which had been closed to our ranchers for a long, long time. I commend the persistence of President Trump, Commerce Secretary Wilbur Ross, Treasury Secretary Steve Mnuchin, the U.S. Trade Representative’s officials, and our own USDA professionals. I also thank our Chinese counterparts, who worked so hard to get this agreement into place. When the Chinese people taste our high-quality U.S. beef, there’s no doubt in my mind that they’ll want more of it.” – Sonny Perdue, U.S. Secretary of Agriculture
Under the trade agreement, cooked Chinese poultry may be imported into the United States once issues related to safety and hygiene are addressed.
Following the expansion of the Panama Canal, a massive construction project that intended to double the cargo capacity of the canal, U.S. ports on the East Coast are enjoying an import boom. In Philadelphia, the Parker Avenue Marine Terminal in South Philadelphia (ranked the 12th nationwide) experienced a 28% bump in April alone.
Over the past year, the Philadelphia port has brought in additional imports of fresh produce from several companies, including Walmart, according to The Inquirer. Since last summer, Mediterranean Shipping Co. has been shipping grapes, blueberries and other fruits from Chile, Peru and Ecuador to Philadelphia on a weekly basis. The company’s cargo ships are the largest to ever have sailed up the Delaware River. Fyffes, a European fresh produce company, began delivering bananas, plantains and pineapples from Costa Rica, Columbia and Guatemala in January.
Whenever possible, I try to spread the word about food safety and share the knowledge gained from my years of experience in various sectors of the food industry, especially from my time managing the Food Safety Tech conferences and webinars. Recently, I even worked it into a presentation about social media marketing for a Pro-Chile Trade Board Event where food safety issues were hot topics throughout the day.
Representatives of more than 30 food manufacturers from Chile attended the event, which was held at the Summer Fancy Food Show in New York City and organized with The Food Institute and Grover Global Food Marketing. Well established in Chile, these producers of gourmet specialty food products wanted to learn the intricacies of selling their cured meats, olive oils, edible flowers, teas, preserves, desserts and snacks in the United States.
The reason: Americans spend a lot on food—$1.5 trillion annually, which is 28% of all retail trade in the United States, according to Brian Todd, president and CEO of The Food Institute, a firm that provides industry news, data and trends. He shared that consumer spending was up 2.3% in 2014 to $6,759 per year per household. Products on the rise include fresh fruits and vegetables, dairy, olive oil, confections and beverages. Key qualities include grab-and-go/convenience, non-GMO, organic, all-natural, healthy, fortified, gluten-free and air-popped/baked.
Todd and other speakers addressed new U.S. government regulations including FSMA, food labeling (nutrition and front of package), bioterrorism, customs, facility registration and certifications. Drilling down into many of the legal details was Lauren Handel, Esq., of Handel Food Law in New Jersey. Handel emphasized the importance of FSMA compliance, in particular, preventive controls, produce safety and foreign supplier verification.
Janis Grover, of Grover Global Food Marketing, who has more than 30 years experience in brand management, pointed out that non-U.S. food manufacturers have an extra hurdle to overcome with the new food safety laws. Grover explained that establishing food safety confidence in their brand with U.S. buyers is critical before they can begin negotiating any importing and distribution deals. According to Grover, to be successful, non-U.S. food manufacturers need to verify with U.S. buyers that they will comply will all U.S. food manufacturing and labeling laws, and that they have the required certifications and other quality control documentation to support their claims.
Sometimes at our FST conferences, speakers and attendees ask about the implementation of our new food safety laws. Will top management provide the funding for quality systems and traceability? Will companies be vigilant about the entire supply chain? Will there be significant and meaningful enforcement by government? Will foreign suppliers comply? I was heartened by the tone and content of the Pro-Chile event and optimistic as I walked the Summer Fancy Food Show with another international client. One of the first statements made to us by a potential U.S. partner was “Do you have a GFSI certificate?” My client did.
UPDATE 2/22/2016 – According to an updated FDA alert, the FY2017 budget requests include an increase of $25.3 million of new budget authority to implement FSMA, with FDA focusing on two main areas:
National Integrated Food Safety System ($11.3 million). Support state capacity to implement the produce safety rule via education and technical assistance to farmers and on‑going compliance support and oversight
New Import Safety Systems ($14.0 million). Implementing the FSVP rule, which makes importers responsible for ensuring that the foods they bring in from other countries are produced in a manner that is consistent with U.S. food safety standards
– END UPDATE –
FDA wants 8% more money for its FY 2017 budget, requesting a total of $5.1 billion. Part of this $14.6 million net increase in budget authority will go toward FSMA implementation. Specifically related to food safety, FDA is asking for more than $18.4 million in budget authority and more than $193.2 million in user fees. According to an FDA press release, the agency will be using the budget to support federal and state efforts related to enforcing safety standards on produce farms. In addition, FDA wants to use the money “to hold importers accountable for verifying that imported food meets U.S. safety standards, as well as conduct food safety audits of foreign food facilities”.
FDA is also requesting more than $3 million for building and facilities funding, and more than $600,000 to support other areas to improve the agency’s infrastructure. The fiscal request is for October 1, 2016 through September 30, 2017.
The FSMA Third Party Accreditation (TPA) final rule was published in the Federal Register in final form on November 27, 2015. Although TPA is not limited to imported food, its primary use will most likely be for food imports. TPA offers foreign food facilities and food importers a way to show FDA that the items coming to the United States meet federal food safety requirements.
An acceptable audit by a certified auditor is the only way an importer can take advantage of another FDA program, the Voluntary Qualified Importer Program (VQIP), which offers expedited review and entry of food. If FDA deems it necessary, the agency can also require certified audits for the import of specific foods.
The TPA process requires a number of administrative steps by FDA and non-FDA entities before the first third-party inspection is made. The four major steps are:
FDA is responsible for officially recognizing accreditation bodies.
An officially recognized accreditation body will accredit third-party certification bodies.
The accredited third-party certification body will certify third-party auditors.
The certified auditors will conduct consultative and regulatory audits of food facilities.
If FDA does not find an applicant that it can officially recognize as an accreditation body within two years, it may directly accredit third-party certification bodies.
In order to recognize an accreditation body, FDA must review an applicant’s legal authority, competency, capacity, conflict-of-interest safeguards, quality assurance and record procedures. By using an already existing framework familiar to industry, accreditation bodies and certification bodies will be allowed to use documentation of their conformance with the International Organization for Standardization and the International Electrotechnical Commission (ISO/IEC) standards, supplemented if necessary, in meeting program requirements under this rule. An official recognition of an accreditation body is granted for up to five years.
FDA is authorized to recognize a foreign government/agency or a private third party as an accreditation body under TPA.
Recognized accreditation bodies under TPA will be required to:
Evaluate potential third-party certification bodies for accreditation, including observing representative samples of the prospective certification body’s work
Monitor performance of the third-party certification bodies it has accredited, including periodical on-site observations, and notifying the FDA of any change in, or withdrawal of, accreditations it has granted
Self-evaluate and correct any problems in their own performance
Submit monitoring and self-assessment reports and other notifications to the FDA
Maintain and provide the FDA access to records required to be kept under the program
Once accredited, third-party certification bodies under TPA are required to perform unannounced facility audits, and to notify the FDA if a condition is found that could cause or contribute to a serious risk to public health.
With FDA’s limited resources, it’s important for the agency to work smarter, not necessarily harder, when it comes to implementing FSMA. During an FDA Town Hall at the Food Safety Consortium last fall, Michael Taylor, deputy commissioner for foods and veterinary medicine at FDA, briefly touched on the agency’s strategy for working with foreign parties to ensure compliance related to importing foods into the United States, including the Food Safety Systems Recognition Agreement with New Zealand.