On Aug. 23 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

The Food and Drug Administration issued a guidance document to help small businesses comply with new Food Safety Modernization Act regulations on intentional adulteration of food, it said. The small entity compliance guide includes information on who must comply with the rule, when compliance is required, food defense and recordkeeping requirements under the final rule, and information on required education and training. Small businesses must comply with the final rule by July 27, 2020. Very small businesses are only subject to documentation requirements that take effect July 26, 2021. The May 2016 final rule requires domestic and foreign food facilities to develop plans to address terrorism risks, but does not apply to carriers nor does it address intentional adulteration such as by disgruntled employees or motivated by economic reasons (see 1605260013).

On Aug. 21 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

Comments are due Oct. 23 on a recently issued draft guidance document on the definition of trading partners, including third-party logistics providers (3PLs), under the Drug Supply Chain Security Act, the Food and Drug Administration said in an updated notice. The change is the result of the agency’s withdrawal of an Aug. 21 notice announcing the new draft guidance (see 1708210034). The updated notice is scheduled for publication Aug. 24, triggering a 60-day period for comments.

The Food and Drug Administration will focus on processed avocados and fresh herbs, specifically cilantro, basil and parsley, in its microbiological sampling program for fiscal years 2017 and 2018, CBP said in a CSMS message. FDA is currently seeking feedback “to ensure that sample collection is done as effectively and efficiently as possible,” including recommendations on how to increase the efficiency of sample collection, additional factors to take into account when reviewing the results of the sampling assignment and input on any food safety initiatives or industry practices related to these commodities. FDA is working “to engage stakeholders earlier and more frequently throughout the assignment development process,” it said.

The Food and Drug Administration created a new Food Safety Plan Builder to help food facilities meet the requirements of Food Safety Modernization Act regulations on preventive controls for human food, it said. The free software application was developed by FDA to “guide [companies], step-by-step, through the creation of a food safety plan, as required by FSMA,” FDA said. A series of tabs in the application prompts the user to answer questions about their business and facility. “Once all the tabs have been completed, the file may be saved or printed, and the firm will have a food safety plan to use in its operations and to provide when the FDA conducts an inspection,” FDA said. The optional program is primarily designed for small manufacturers, but “any size manufacturer can opt to use it,” the agency said. FDA also posted a series of videos and a guide on how to use the plan builder. Preventive controls rules for human food began to take effect in September 2016, with the next compliance date coming for small businesses on Sept. 18, 2017 (see 1509100021).

On Aug. 18 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

The Food and Drug Administration plans to release its new Import Trade Auxiliary Communication System (ITACS) account management functionality on Sept. 18, it said. The new capabilities, which were the subject of a pilot conducted in 2016 (see 1606220042), will enable electronic distribution of FDA Notices of Action via email and as downloads in ITACS, and will also allow account holders to “view the details of specific information requests, which are currently delivered via hard copy” notices, FDA said. Benefits include faster receipt of FDA notices of action and requests for information and no need to maintain copies of paper notices, the agency said.

On Aug. 17 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

The Food and Drug Administration issued its weekly Enforcement Report for Aug. 16 that lists the status of recalls and field corrections for food, drugs, biologics and devices. The report covers both domestic and foreign firms.