Navigating the Process of Importing Food Products into the United States Q and A

Responses to Some Questions Poised in EAS, Certified Laboratories and L&L Trade Law Webinar on Navigating FDA Food Imports and Detentions

Regulatory questions answered by EAS Consulting Group

What actions do you anticipate FDA will take on imports in response to the newly revised zero tolerance of Chlorpyrifos? How likely is it that FDA will begin testing imports for Chlorpyrifos contamination?

“On February 9, 2022, FDA Released a Guidance for Industry on Enforcement Approach to Human Food with Chlorpyrifos Residues Following EPA Tolerance Revocations. The guidance states the FDA’s approach will be in two phases and applies to both raw agricultural commodities and processed foods. Stage 1: The Agency intends to exercise enforcement discretion by not requesting showing documentation for residues complying with previous tolerances for a time period ranging from approximately 6 to 24 months, depending on the specific commodity. This is based on our estimate of how long raw agricultural commodities would remain on the market (e.g., time for growing and postharvest storage, distribution, and sale). Stage 2: The Agency will accept showing documentation that demonstrates that chlorpyrifos was applied before February 28, 2022. If the responsible party does not provide appropriate documentation, the food may be subject to regulatory action. Reference = https://www.fda.gov/food/cfsan-constituent-updates/fda-releases-guidance-industry-enforcement-approach-human-food-chlorpyrifos-residues-following-epa

In addition, FDA has posted a Questions and Answers Regarding Channels of Trade Policy for Human Food Commodities with Chlorpyrifos Residues: Guidance for Industry. for imported food containing chlorpyrifos residues that is offered for importation before the showing dates (see Table 1 -Showing dates for chlorpyrifos residues in various RACs in the reference below), during Stage 1, we generally intend to consider residues within the tolerance to be subject to the channels of trade provision. After Stage 1, FDA intends to inform the responsible party (e.g., the importer) that the food appears to be in violation of the FD&C Act and provide an opportunity for the party to respond and provide documentation to show that the residues in food resulted from lawful application to RACs before February 28, 2022. For example, food processors could demonstrate that a RAC used in processed food was received for processing on or by the showing date. Reference – https://www.fda.gov/media/156012/download

Is FCE and SID needed for canned packaging products or any acidified and LACF commodity, as few of the detention is because of SID and FCE. Please advise how we can differentiate.

The Food Canning Establishment Code (FCE) is a unique number assigned to each facility that process acidified and low acid canned food in hermetically sealed container. The processor must submit the FDA Form FDA 2541. The FCE consist of 5 digits.

When the FCE Registration is submitted to FDA, the manufacturer must also submit to FDA its Scheduled Process filings for all of its commercially sterile, acidified and low-acid canned foods to obtain a Scheduled Process Identification (SID) Number from FDA for each specific canned food and aseptic or acidified food .  The SID Scheduled process identifier number consists of 11 digits as follow YYYYMMDDSSS – • YYYY represents the calendar year • MM represents the month (e.g., 02 for February, 10 for October) • DD represents the day of the month (e.g., 02, 19, 30, etc.) • SSS represents a unique sequence number to identify each process submitted to FDA by the manufacturer on the same date.

The manufacturer’s scheduled process must be reviewed and approved by FDA before any canned food is permitted to enter the United States. If a manufacturer modifies the manufacturing process. the type of container, acidulators or aseptic processing equipment then the manufacturer is required to submit updated SID filing. FDA reviews a manufacturer’s scheduled processes in order to reduce the risk of botulism poisoning in the food product. Food offered for import that is manufactured in a facility with an active FCE registration number, but does not have an SID number for the imported product will be refused admission into the United States. It is important that the SID number is accurately reflected in the customs paperwork filings. Failure to accurately report the SID number associated with the food product will result in detention or refusal of admission.

Which shipment documents must be Originals and which can be Copies? Should they be attached to shipment? such as COO’s or CITES documents that require signatures.

Because FDA handles all import entries via the US Custom Automated Customer Environment (ACE) acceptable documents could be an original converted into a Portable Document Format (PDF). PDF meets the needs for legal admissibility in court as an electronic format that is read only and will leave an electronic trail if altered.

The US Fish and Wildlife Service requires CITES documents. The document must be in original form demonstrating the confirmation by the issuing authority that the conditions for authorizing the trade are fulfilled; this means that the trade is legal, sustainable and traceable in accordance with Art. III, IV and V of the Convention. The national CITES Management Authority or Authorities of each Party are the issuing authorities of CITES permits upon advice from the national CITES Scientific Authority. Parties have a permit or certificate form, whether issued in an electronic or paper format, includes a place for the signature of the applicant, the absence of the handwritten signature or in case of electronic forms any electronic equivalent should render the permit or certificate invalid.

I have a situation where there is a food import that is being shipped to a bonded warehouse in the US, to be loaded on a cruise ship and used in a duty-free zone. What food labeling laws should the product comply with? The country of origin (where imported from) or the US (where the bonded warehouse and cruise ship are)?

You need to follow the FDA labeling regulations. The Dut- Free zone is an area where products are sold without the import, sales, value-added or other taxes. These products are sold to the international travelers with an understanding that they will take these products outside of the country to use. In the United Stated Duty- Free Zone and Free Trade Zone are under the authority for inspection by the FDA which regulates food labelling in the United States and also has authority over the labelling of dietary supplements, cosmetics, drugs (both prescription and over-the-counter), medical devices, devices that emit radiation, animal foods, drugs and cosmetics. FDA does not make an admissibility decision when products are brought into the FTZ, FDA does still have jurisdiction over those products. For purposes of the Act, products located within FTZs are regulated under the domestic provisions of the Act until they are offered for entry.

How does an importer prove they have completed FSVP?

The importer must establish, sustain, and adhere to a Foreign Supplier Verification Program (FSVP) that adequately documents affirmations that the 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 in the Hazard Analysis and risk-based preventive controls (HARPC/ Preventive Control Rule) and the new Standards for Produce Safety. 21 C.F.R. 1.502(a). Additionally, food importers must verify that imported food is not adulterated, or misbranded because it fails to disclose the presence of major food allergens in compliance with the Federal Food, Drug and Cosmetic Act.   The specific food safety protocols in any given FSVP plan will depend upon a variety of factors, including inherent risks associated with the food or the processing steps, the region or country of origin of the food, the ingredients used, the number of manufacturing parties involved in making the food, etc.

The FSVP provision identifies some activities appropriate to verify that the food they import is safe — that it meets the statutory food safety outcomes outlined in the FSMA. These include: Monitoring shipment records that might reveal the food is safe; Conducting annual on-site inspections of the foreign supplier; Obtaining a copy of and evaluating the Foreign Supplier’s HARPC Plan or records proving food complies with applicable Standards of Produce Safety; Lot-by-lot food certification of compliance. Periodic sampling and testing shipments challenging manufacturer Certificates of Analyses

Maintain for two years signed and dated FSVP records, including records related to their hazard analysis, supplier evaluation and approval program, supplier verification activities, and any corrective actions undertaken to address identified food safety problems. Certain activities related to designing, implementing, and managing an FSVP must be carried out by a qualified individual (or team of individuals, qualified for their respective roles), who must have the training, education, or experience (or some combination) necessary to undertake the FSVP activities.

Is FSVP required for food contact substance or processing aids?

FDA in their final rule comments (11/27/2015 Federal Register 80 FR 74225) comments of the FSVP indicated not agreeing that is was appropriate to exclude food contact substances (including food packaging), as defined in section 409(h)(6) of the FD&C Act (21 U.S.C. 348(h)(6)), from the definition of “food” for FSVP purposes. The term “food” is defined in section 201(f)(3) of the FD&C Act to include articles used as components of food, and the case law interpreting the definition makes clear that many substances that meet the definition of food contact substances under section 409(h)(6) of the FD&C Act also meet the definition of food (see, e.g., Natick Paperboard v. Weinberger, 525 F.2d 1103 (1st Cir. 1975) (paperboard containing PCBs intended for food use is adulterated food); U.S. v. Articles of Food 688 Cases of Pottery (Cathy Rose), 370 F. Supp. 371 (E.D. Mi. 1974) (ceramic pottery that leaches lead is adulterated food)). FDA stated not believing there is any evidence that Congress intended to exclude food contact substances from being considered “food” for purposes of section 805 and the FSVP regulation.

Regarding import alerts telling officers they may detain without examination. Are entries for imports under DWPE automatically detained, or is that up to the discretion of the officers/manually done?

An Import Alert is a general document for FDA’s field staff and the public that the agency has enough evidence to allow for Detention Without Physical Examination (DWPE) of products that appear to be in violation of the FDA’s laws and regulations. A Detention Without Physical Examination (DWPE) is recommendation to the FDA Import District when there is information that would cause future shipments of a product or products offered for entry to appear violative within the meaning of Section 801(a). The FDA officer will act detaining the imported product under the admissibility import process review. Since FDA receives the import declaration via the ACE system once the product is placed under detention the electronic message is send back to the broker. All depends on when the import entry was received and review and the admissibility decision. In addition, FDA uses a tool known as PREDICT this has the criteria to select product for further review. The criteria in PREDICT is dynamic to change constantly by FDA at any time of the day. Once a decision is made the message could take minutes to be on the ACE system. FDA reserves the right of discretion on compliance activities is weighted under the review process.

Regarding import alerts telling officers they may detain without examination. Are entries for imports under DWPE automatically detained, or is that up to the discretion of the officers/manually done?

An Import Alert is a general document for FDA’s field staff and the public that the agency has enough evidence to allow for Detention Without Physical Examination (DWPE) of products that appear to be in violation of the FDA’s laws and regulations. A Detention Without Physical Examination (DWPE) is recommendation to the FDA Import District when there is information that would cause future shipments of a product or products offered for entry to appear violative within the meaning of Section 801(a). The FDA officer will act detaining the imported product under the admissibility import process review. Since FDA receives the import declaration via the ACE system once the product is placed under detention the electronic message is send back to the broker. All depends on when the import entry was received and review and the admissibility decision. In addition, FDA uses a tool known as PREDICT this has the criteria to select product for further review. The criteria in PREDICT is dynamic to change constantly by FDA at any time of the day. Once a decision is made the message could take minutes to be on the ACE system. FDA reserves the right of discretion on compliance activities is weighted under the review process.

We are importers but we use a broker to import products. Who is required to have FSVP? If we purchased direct from a foreign supplier, is that when we are required to have FSVP of that specific product?

A broker assists importers in meeting federal requirements governing imports into the United States. A broker is not covered under the Foreign Supplier Verification Program (FSVP) because oversee transactions related to customs entry and admissibility of merchandise, product classification, customs valuation, payment of duties, taxes, or other charges such as refunds, rebates, and duty drawbacks. The foreign supplier verification programs (FSVPs) for importers of food for humans and animals. FSVP final rule is consistent with the supply-chain program provisions. The regulation requires importers to verify that food they import into the United States is produced in compliance with the hazard analysis and risk-based preventive controls and standards for produce safety provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), is not adulterated, and is not misbranded with respect to food allergen labeling. You as importer will be required to have an FSVP for all products that foreseeable have a food safety hazards, identified and considered through a hazard analysis and evaluation process, rather than all adulteration covered by the adulteration provisions in section 402 of the FD&C Act. Although FSVP requirements apply to most imported food under FDA’s regulatory jurisdiction, certain categories of imported food are not covered under the FSVP regulation. These exemptions include certain juice, fish, and fishery products (which are already subject to verification under FDA’s hazard analysis and critical control point (HACCP) regulations for those products), food for research or evaluation, food for personal consumption, alcoholic beverages, food that is transshipped, food imported for processing and future export, food exported from and returned to the United States without manufacturing/processing in a foreign country, and certain meat, poultry, and egg products regulated by the U.S. Department of Agriculture (USDA). You are required to maintain for two years signed and dated FSVP records, including records related to their hazard analysis, supplier evaluation and approval program, supplier verification activities, and any corrective actions undertaken to address identified food safety problems. Because of certain activities related to designing, implementing, and managing an FSVP must be carried out by a qualified individual (or team of individuals, qualified for their respective roles), who must have the training, education, or experience (or some combination) necessary to undertake the FSVP activities.

Testing questions answered by Certified Laboratories

Does FDA will allow lab testing in countries of origin?

As it stands today, the FDA does not recognize laboratories in the country of origin for FDA Detention Without Prior Examination. There is a traceability concern with this option due to fraud in previous attempts. Ensuring the samples actually were pulled randomly from the container in question is a deterrent for the FDA.

Is there a list of ‘approved labs’ that FDA will accept test results from?

While there are a limited number of labs that have chosen to perform FDA DWPE sampling and testing due to its complexity, there are a few. The real issue is whether or not the labs have validated methods for a particular product matrix.

The FDA requires that a validation be performed for like products. The FDA requires that the validation be submitted from an entry along with the test results if not previously submitted. The FDA will then review the validation to ensure that proper protocols were followed and are valid.

There is however a new FSMA Rule on Laboratory Accreditation for Analyses of Foods that is underway in which laboratories will be have to be ISO 17025 accredited and will have to submit all validations to the FDA. It is intended that then the FDA will have a list of approved laboratories that will be able to submit results for FDA DWPE and the removal from the ‘RED LIST’. This list will be published on an FDA website.

In the interim, Certified Laboratories has 100’s of validations which have been submitted to the FDA on various matrices. If we can ever be of assistance, please feel free to reach out to me directly.

What is Certified Laboratories’ typical turn around for analysis from Micro or MRL testing?

Typical turnaround time for Micro testing is 5-7 days and MRL testing 7-10 days (rush on request – 5-7 days).

We invite you to contact us with any questions pertaining to your FDA or USDA imports.