Food Industry Regulatory Update December 3, 2021

In This Week’s Edition:

APHIS Authorizes Importation of Mango from Colombia
Oklahoma State University Petitions USDA to Classify Beef Hides as Edible
FDA Proposes Regulatory Relief in Changes to Agricultural Water Requirements in the FSMA Produce Safety Rule
FSIS FOIA Request Report Update
FDA Issues FSMA Final Rule for Laboratory Accreditation for Analyses of Foods
FSIS Revises Directive on Investigative Methodology
FSIS Revises Directive on Experimental and Sample Products Policy
FSIS Final Rule BSE Prevention and Importation of Sheep, Goats, and Certain Other Ruminants.
FDA CORE Outbreak Investigation Status Update
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
FDA Import Alerts
FDA Warning Letters

APHIS Authorizes Importation of Mango from Colombia

APHIS released notice of their decision to authorize the importation into the United States of fresh mango fruit from Colombia

Oklahoma State University Petitions USDA to Classify Beef Hides as Edible

A new USDA petition by Robert M. Kerr Food Center at OSU requests that 9 CFR 325.19(e) be amended to exclude hides from articles that are considered as naturally inedible by humans under the Federal Meat Inspection Act.

FDA Proposes Regulatory Relief in Changes to Agricultural Water Requirements in the FSMA Produce Safety Rule

FDA published a proposed rule that would revise subpart E of the FSMA Produce Safety Rule to change certain pre-harvest agricultural water requirements for covered produce other than sprouts. Instead of mandatory microbiological testing, farms would be required to conduct annual systems-based agricultural water assessments to determine and guide appropriate measures to minimize potential risks associated with pre-harvest agricultural water. The assessment would include an evaluation of the water system, agricultural water use practices, crop characteristics, environmental conditions, potential impacts on source water by activities conducted on adjacent and nearby land, and other relevant factors, such as the results of optional testing.

FSIS Food Safety and Inspection Service FOIA Request Report Update

Read the full FOIA requests report here.

FDA Issues FSMA Final Rule for Laboratory Accreditation for Analyses of Foods

FDA issued a final rule establishing the Laboratory Accreditation for Analyses of Foods (LAAF) program as required by FSMA.

Under the LAAF program, the FDA will recognize accreditation bodies (ABs) that will accredit food testing laboratories to standards established in the final rule (referred to as LAAF-accredited laboratories). The final rule outlines eligibility requirements that ABs and laboratories will need to satisfy to participate in the program, as well as procedures for how the FDA will manage and oversee the program.

Currently, food testing, including environmental testing, is largely completed by private laboratories that may conform to a variety of standards and be subject to various levels of oversight. Once the LAAF program is fully implemented, only LAAF-accredited laboratories will be able to conduct food testing in certain circumstances that are defined in the final rule.

The LAAF program will cover food testing:

to support removal of a food from an import alert through successful consecutive testing requirements;
to support admission of an imported food detained at the border because it is or appears to be in violation of the Federal Food, Drug, and Cosmetic Act;
required by existing FDA food safety regulations, when applied to address an identified or suspected food safety problem (i.e., certain tests of shell eggs, sprouts, and bottled drinking water);
required by a directed food laboratory order, a new procedure being implemented in this final rule that will allow the FDA to require use of a LAAF-accredited laboratory to address an identified or suspected food safety problem in certain, rare circumstances; and
conducted in connection with certain administrative processes such as testing submitted in connection with an appeal of an administrative detention order.

FSIS Directive on Investigative Methodology

The directive updates instructions to Office of Investigation, OIEA, CID Investigators on the methods for conducting investigations of apparent violations, food safety incidents, food defense incidents, or other allegations or incidents under the FMIA, PPIA, EPIA, HMSA, and related laws and regulations

FSIS Updates Directive on Experimental and Sample Products Policy

The directive updates instructions to FSIS personnel concerning the domestic production of experimental products and sample products. FSIS is reissuing this directive to provide more detailed labeling information for sample products and for experimental products and to update references. In addition, this directive was updated to remove the requirements for experimental products from foreign countries that are imported to the United States. Instructions regarding requirements for sample and experimental products from foreign countries are found in FSIS Directive 9500.8, Importation of Products for Other Than Commercial Purposes.

FSIS Final Rule on BSE Prevention and Importation of Sheep, Goats, and Certain Other Ruminants.

Read the full final rule updating the requirements related to BSE prevention for the importation of sheep, goats, and certain other ruminants here.

FDA CORE Outbreak Investigation Status Update

This week’s updates are:

The case count for Salmonella Javiana in an unknown food has increased to 28 cases, and a traceback investigation has been initiated.
For the E. coli outbreak in spinach, an on-site inspection has been initiated.

CORE Investigation Table