Tag Archives: importer

AFSAP

FDA Issues First Import Alert for FSVP Non Compliance

By Trish Wester
No Comments
AFSAP

The Import Alert for FSVP noncompliance is applicable to any human and animal food subject to the FSVP regulation, and allows FDA to detain imported foods at the port of entry under the protocol for Detention Without Physical Examination (DWPE). DWPE is a standard enforcement tool for FDA.

July 31, 2019: FDA issued Import Alert #99-41, the first Import Alert based on noncompliance with the Foreign Supplier Verification Program (FSVP) regulation.
The FSVP Import Alert contains the following reason for the alert and the relevant charge.

Reason

“Section 805 of the FD&C Act (21 U.S.C. 384a) requires each importer of food to perform risk-based foreign supplier verification activities for the purpose of verifying that the food imported by the importer is produced in compliance with the requirements of section 418 (21 U.S.C. 350g) (regarding hazard analysis and risk-based preventive controls) or section 419 (21 U.S.C 350h)(regarding standards for produce safety) of the FD&C Act, as appropriate; and that the food is not adulterated under section 402 or misbranded under section 403(w).” – FDA

Charge

“The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in that it appears that the importer (as defined in section 805 of the FD&C Act) is in violation of section 805.” – FDA

Join Trish Wester for the closing plenary 2019 Food Safety Consortium panel discussion FDA Presentation on The Third-Party Certification Program | Thursday, October 3, 2019“Import alerts inform the 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. These violations could be related to the product, manufacturer, shipper and/or other information,” states FDA on its webpage about import alerts.

A Trend of Increased Import Enforcement?

FDA enforcement actions in this area have recently seen a dramatic increase. Only one alert was posted in the first quarter, and less than 10 food-related alerts were posted prior to June. July 2019 saw eight food alerts, including one on radionuclides and the FSVP. FDA posted more than 30 food-related import alerts in August, and September is on a similar pace currently showing 21 food-related alerts, indicating this may be an ongoing focus for the agency.

The information in this update is provided by AFSAP, the Association for Food Safety Auditing Professionals. Please contact Patricia Wester @ trish@pawesta.com if you have any questions regarding DWPE, or to request a complete copy of the alert.

Imports

Import Safe Food, Stay Out of Trouble with FDA

By Maria Fontanazza
1 Comment
Imports

Food importers have clear objectives: To successfully bring safe food into the country by clearing U.S. Customs and Border Protection, to avoid FDA detention and to conduct business competitively in the United States. Under the FSMA final rule on Foreign Supplier Verification Programs (FSVP), importers must ensure their food is as safe as if it were produced in the United States and that it is not adulterated or misbranded.

Compliance, of course, is of utmost importance when it comes to avoiding issues with the FDA. However, in a more realistic sense, the best way to stay out of trouble with FDA is to avoid two circumstances, advised Russell Statman, executive director at Registrar Corp. (the firm is a U.S. agent for about 15,000 foreign facilities)—being dishonest and not taking the requirements seriously.

“Once you fall into one of those boxes, you’ll never get out,” Statman said. “It’s important when dealing with FDA to remember that. It’s not a building; it’s people. They don’t want to stop your shipments; they want to facilitate trade.” If your company is honestly working toward and making an effort to follow the rules, “FDA will keep working with you until the cows come home,” he said.

Statman discussed practical information surrounding FSVP that importers should consider during the Food Safety Supply Chain Conference earlier this week. Although there is flexibility built into the FSVP rule (as there is with all seven FSMA rules), importers must follow the law. To start, every importer must have DUNS number (provided by Dun & Bradstreet), which is free of charge. However, this can be a challenge for foreign companies, particularly those in China, according to Statman, who also said there may be instances in which Dun & Bradstreet tries to charge a fee. “It’s supposed to be free and quick. If you have problems with Dun & Bradstreet, you want to let FDA know.” He offered key pieces of advice for the FSVP requirements:

  • Hazard analysis. “You can’t rely on other people. If you’re producing food, do your own hazard analysis. Create a pamphlet that you can give to your customers. Then you don’t have to deal with all these requests—keep updating [the pamphlet], so it’s a living document. If you’re a foreign supplier and have a booklet, you’re steps ahead of your competition.”
  • Approval and compliance status review of suppliers: Check their record with FDA to find out whether they have any warning letters or on import alert. “That doesn’t mean you can’t buy from them, it just means you have to investigate what the problem is,” said Statman, but added that a lot of U.S. companies will not buy from importers that are flagged with an alert. And in many cases, companies do not know that they’re on import alert, so visit FDA’s website frequently to make sure you’re not on the list. “FDA doesn’t tell you when you’re on import alert. You want to check [because] asking them might not be good enough.”
  • Supplier verification activities: Verify that importers follow the entire rule.
  • Corrective actions
  • Periodic reassessment of FSVP
  • Importer identification at entry (DUNS number)
  • Recordkeeping: “In a very real, practical sense, your record stays with you,” said Statman. “If you’re an importer, you don’t want your shipment detained by FDA.” FDA uses a computer system called PREDICT that determines which entries they stop. The system comes up with a score for shipments that are at the highest risk. “Your PREDICT score if very important—some of these factors are secret, [and] some are public. The most important are in your control—your record and the importers record,” he added. “Before you send your first shipment for a new product, make sure everything is correct (i.e., registration, labeling). It’s worth the time.”

 

FSMA, Food Safety Tech, FDA

FDA Releases New Guidance on Foreign Supplier Verification Program

By Food Safety Tech Staff
No Comments
FSMA, Food Safety Tech, FDA

With the first FSVP compliance rule just two weeks away, FDA has published a new guidance to help importers that are subject to the rule. “Guidance for Industry: Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs Regulation” specifically provides information on the following:

  • How an organization identifies itself as an importer of food at entry into the United States
  • Requirement to provide a unique facility identifier that is acceptable by FDA
  • Information on what to do if the importer cannot obtain a Dun & Bradstreet Data Universal Numbering System number in time for the compliance date

FDA also identified the importers that fall under the May 30, 2017 compliance date. The foreign supplier would fall into one of the following categories:

  • The supplier will not be covered by the FSMA PC or Produce Safety rules
  • The supplier is subject to the Preventive Controls for Human Food rule and is not a small business, qualified facility or subject to the Pasteurized Milk Ordinance
  • The supplier is subject to CGMP requirements in the FSMA Preventive Controls for Animal Food rule and is not a small business or qualified facility

For importers that are unsure as to whether they are required to comply with the FSVP rule, the agency released a one-page chart, “Am I Subject to FSVP?”, along with a fact sheet about the final rule and the requirements under it, compliance dates and additional information.

Imports

FSMA’s FSVP: Clearing the Confusion of Importing Rules

By Charles Breen
No Comments
Imports

On November 27, 2015, the Foreign Supplier Verification Programs for Food Importers (FSVP Rule) published in the Federal Register. The most significant new element is that importers are now responsible for assuring that the food they import complies with FDA requirements. Instead of action against violative food, FDA is now equipped to take regulatory action against importers that fail to provide necessary assurance of food safety.

“Importer” is defined as: “the U.S. owner or consignee of an article of food that is being offered for import into the United States. If there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the importer is the U.S. agent or representative of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent to serve as the importer under the FSVP regulations.” This differs from the importer of record as defined by Customs and Border Protection (CBP) as the person primarily responsible for paying any duties or an authorized agent acting on his behalf.

Under FSVP, an importer’s basic responsibilities are to:

  • Determine hazards reasonably likely to cause illness or injury
  • Evaluate the risk, using hazard analysis
  • Evaluate the foreign supplier’s performance
  • Perform supplier verification activities

Determining hazards and evaluating risk parallel the preventive control rules for human food (PCHF) and animal food (PCAF). Evaluation of a foreign supplier’s food safety performance and conducting verification activities are substantially aligned with supply-chain verification in 21 CFR 117 Subpart F (PCHF) and 21 CFR 507 Subpart E (PCAF). The importer is responsible for assuring compliance with FDA standards and requirements.

Deciding what parts of FSVP are applicable to each importer’s operation requires a comparison between what the importer does, and the exemptions, exceptions and modified requirements offered in the rule. These depend on what is imported, the food safety system in country of origin, the size of the importer, and the size of the foreign supplier. FDA delivered on its promise of flexibility, but deciding what applies requires some analysis.

If a food importer meets the definition of importer and does not fall into an exempted category or qualify for exceptions or modifications, then some or all of the FSVP rule applies to them. FDA estimates that about 55,000 importers will be covered by FSVP or some portion of it.

Who Is an Importer?

The U.S. owner or consignee of an article of food that is being offered for import into the United States is the importer. If there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the U.S. agent or representative of the foreign owner or consignee at the time of entry is the importer.

All importers must provide an identification number for each entry line of food that the importer brings into the country. FDA will be issuing more guidance on what it considers “an acceptable identification number.”  The agency is not mandating that each facility use a DUNS number, but is has ruled out other suggestions for the unique identification number that is required.

Exemptions to FSVP

FSVP does not apply to the following foods:

  • Fish and fishery products (in compliance seafood HACCP in 21 CRF 123)
  • Juice (in compliance with juice HACCP in 21 CFR 120)
  • Food for research or evaluation
  • Alcoholic beverages
  • Meat, poultry, and egg products regulated by USDA
  • Food imported for personal consumption,
  • Food that is transshipped through the United States
  • Food that is imported for processing and later export
  • U.S. food that is exported and returned without further manufacturing or processing in a foreign country (U.S. foods returned)

Partial exemption for import of low-acid canned foods (LACF). LACF are exempt from FSVP with respect to microbiological hazards for that food. To be exempt, the importer must verify and document that the food was produced in accordance with LACF requirements (21 CFR part 113). Other hazards not controlled by the LACF rule, if any, must be documented as controlled under FSVP.

Modified Requirements

Modified requirements for a receiving facility in compliance with the PCHF or PCAF rules that imports food:

  • If the process used controls the hazards of the imported food, the facility is considered in compliance with most of the FSVP rule.
  • If the food does not have any identified hazards requiring control, then the facility is considered in compliance with most of the FSVP rule.
  • If the facility has implemented a supply-chain program for the food in compliance with either PCHF or PCAF requirements, the facility is considered to be in compliance with most of the FSVP rule.

Receiving facilities must also accurately identify themselves to FDA for each entry line of food being imported.

Modified requirements for imported dietary supplements manufactured in compliance with CGMP requirements in 21 CFR part 111:

The importer must accurately identify itself to FDA for each entry line of dietary supplement or dietary ingredient being imported.

Modified requirements for very small importers:

Defined as less than $1 million in sales of human food a year, or less than $2.5 million in sales of animal food per year, very small importers would not have to conduct hazard analyses and would be able to verify their foreign suppliers by obtaining written assurances of compliance from those facilities.

Modified requirements for imports from small suppliers (i.e., qualified facilities under PCHF or PCAF, and some small farms not covered farms under the produce safety standards, and some small egg producers):

The importer must obtain written assurance before importing the food, and at least every two years after, that the foreign supplier is producing the food in compliance with applicable FDA food safety regulations or the laws and regulations of a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States.

Modified requirements for food imported from a country with an officially recognized or equivalent food safety system:

Importers must determine that the supplier is in compliance with FDA requirements, or that the supplier is in compliance with food safety regulations or relevant laws in the country that FDA recognizes as equivalent.

At present, only New Zealand is officially recognized as comparable to the United States. FDA is in the process of auditing and evaluating audit results for mutual recognition with additional countries. The next countries to be recognized will most likely be Australia and Canada.

One final note: FSVP requires coverage of food contact surfaces, such as packaging. Manufacturers of food contact surfaces are not required to register with FDA. PCHF and PCAF rules are limited to those facilities required to register. The language requiring FSVP makes no exception for food contact surfaces.