Import Alert 71-02

Import Alert # 71-02

Published Date: 07/20/2021

Type: DWPE

"Detention Without Physical Examination Of Animal Feeds And Feed Ingredients That May Contain Ingredients Of Animal Origin"

Note: The revision of this Import Alert (IA) dated 07/19/2021 updates the reason for alert and guidance section, agency contacts, and product description. Changes to the import alert are bracketed by asterisks (***).

The United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS) regulates the importation of animals and animal-origin materials. Bovine spongiform encephalopathy (BSE) is not the only reason USDA APHIS regulates the importation of animals and animal-origin materials into the U.S. although BSE is the focus of this particular import alert. USDA APHIS classifies foreign countries' BSE risk status as negligible, controlled, or undetermined. ***They maintain a list of countries' BSE status which can be searched through their website, https://www.aphis.usda.gov/aphis/home ***. USDA's BSE restrictions and requirements are codified in 9 CFR part 94 and 9 CFR part 95.

Given their responsibility for regulating the import of animals and animal-origin materials into the U.S., USDA APHIS also shares with FDA some regulatory authority over the importation of certain animal feed/feed ingredients. In general, almost all imported feeds and feed ingredients that contain animal-origin material should be accompanied by a valid USDA import permit (VS Form 16-6A) and/or government-issued veterinary health certificate (zoosanitary certificate). As per APHIS's BSE comprehensive rule, APHIS restricts or prohibits the importation of certain animal-origin material based on the BSE risk status of the region of origin/export. USDA APHIS regulates the importation of animal feeds or feed ingredients that contain or consist of rendered meals, digests, and hydrolyzed proteins (e.g. meat and bone meal, other "meals"), regardless of country of export or species of origin. In addition, APHIS regulates the importation of animal feed/feed ingredients containing certain other animal by-products for BSE risk mitigation.

BSE is a bovine form of uniformly fatal neurological diseases known as TSEs (Transmissible Spongiform Encephalopathies). BSE is spread by feeding infectious material to cattle. At this time, the causative agent is known to be a mis-formed prion which, when consumed by cattle, may lead to development of the disease. There is no test for the presence of the agent in animal-origin materials. BSE is treated as a public health matter because the consumption of contaminated beef has been linked to a human TSE disease known as vCJD (new variant Creutzfeldt-Jakob Disease).

In support of these USDA import prohibitions, and to monitor for compliance with FDA's regulations found in 21 CFR 589.2000 ("Animal proteins prohibited in ruminant food") and 589.2001 ("Cattle materials prohibited in animal food or feed to prevent the transmission of bovine spongiform encephalopathy"), the FDA has a sampling program to conduct sampling and analysis of feed and feed ingredients offered for entry into the U.S. for the presence of animal-origin material.

Divisions may detain, without physical examination products offered for import from those firms that are identified on the red list of this import alert as they have been found to offer product(s) containing animal-origin material prohibited by 21 CFR 589.2000 and/or 589.2001.

Recommendations for additions to the red list of this import alert should be forwarded to the Division of Import Operations (DIO). DIO and FDA's Center for Veterinary Medicine (CVM) will evaluate regulatory packages on a case-by-case basis.

***Release of Articles Subject to Detention Without Physical Examination Under This Import Alert:***In order to secure release of an individual shipment identified for detention without physical examination under this import alert, the owner, consignee and/or another responsible party should provide the results of private laboratory analysis of a representative sample of the detained product, which demonstrates that the product does not bear or contain animal-origin materials not in compliance with 21 CFR 589.2000 and/or 589.2001.

***Proper sampling and analytical records should be submitted to the appropriate FDA Division compliance office for consideration per the notice of detention. For further information regarding private laboratory analyses, please reference FDA's ORA Lab Manual, volume III, section 7. Following receipt and review of private laboratory results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article.***

*** Removal from Detention without Physical Examination (REMOVE FROM RED LIST):***

In order to remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The information should help the Agency have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act) and implementing regulations.

FDA recommends that firms requesting removal from DWPE provide the following information:

1. Evidence that the firm has determined that the products it is importing are in compliance with 21 CFR 589.2000 and 589.2001, because it has taken appropriate steps to prevent the presence of prohibited animal-origin material in its products. This should be documented by:

a. Results of the firm's own investigation(s) into the root cause of the violation that led the firm to be placed on DWPE.

b. Documentation showing corrective action(s), including at a minimum:

i) A description of the current processes being used to prevent the presence of prohibited animal-origin materials; and

ii) Verification that the processes are adequate.

c. Documentation that a minimum of five (5) consecutive shipments of a specific product detained pursuant to this import alert have been released by FDA based on private laboratory analyses using feed microscopy, polymerase chain-reaction (PCR), or a combination of both methods, to show the shipments contained no prohibited animal-origin materials.

Requests to remove from the red list multiple products from a manufacturer should include a minimum of twelve (12) import entries representative of products covered by detention without physical examination.

OR

2. Documentation demonstrating ongoing compliance with the applicable provisions of 21 CFR 589.2000 and 589.2001. Examples of information that firms may provide to demonstrate ongoing compliance with the requirements include:

a. Results of the firm's own investigation(s) into the root cause of the violation that led the firm to be placed on DWPE.

b. Documentation showing corrective action(s), including at a minimum:

i) A description of the current processes being used to prevent the presence of prohibited animal-origin materials; and

ii) Verification that the processes are adequate.

c. Copies of current, written procedures that explain the firm's manufacturing process, and which demonstrate an understanding of the requirements of 21 CFR 589.2000 and 589.2001.

d. Copies of manufacturing records demonstrating that the firm's products are being manufactured according to the process described in the firm's written procedures.

e. Photographs showing the processing equipment, including any new, adjusted, or cleaned equipment, for example.

f. Documentation showing that the facility has been inspected or evaluated by the regulatory authority in the country of origin after the violation that led the firm to be placed on DWPE and that there were no findings from the inspection or evaluation that would give rise to an appearance that the violation continues.

OR

3. Evidence that the product is the subject of a valid USDA import permit (VS Form 16-6A), if the product contains animal-origin materials.

For additional, general guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)."

*** If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address:

Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or, be sent via email to: Importalerts2@fda.hhs.gov

Requests for removal from detention without physical examination will be reviewed by the subject matter experts within the Division of Import Operation (DIO) and referred to CVM for evaluation.

Questions or issues involving import operations should be addressed to ORA/DIO at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov

Questions or issues involving OASIS or PREDICT screening should be addressed to ORA/DSS/Import Systems Branch at oraoismdssimpcomplsysbr@fda.hhs.gov.

Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at oraorsprivatelabimportalerts@fda.hhs.gov.

Other questions may be directed to CVM's Division of Compliance at CVMImportRequests@fda.hhs.gov ***

***Animal feeds and feed ingredients***

"The article is subject to refusal of admission pursuant to Section 801(a)(1) in that it appears that such article has been manufactured, processed, or packed under insanitary conditions."

OASIS Charge Code: MFR INSAN

Desc: Soybean Meal/Organic Soy Meal

Desc: Soybean Meal/Organic Soy Meal

Desc: CATTLE FEED MIXED RATION-NONMEDICATED