Here is section “I” of the current version of FDA’s Acidified Process Filing form 2541e.  Here are some hints for completing the form when using a hot fill hold (HFH) process.

  • First, note the blacked out portions.  Nothing needs to be entered in these areas.
  • Column 1 is 01 for your first filing (of the form).
  • Column 2 is 01 for the first step (in this one step process)
  • Column 3 – check the box “Lowest Hold temp.” and below the word Fahrenheit write in the temperature provided by your process authority.  A standardized default value often used is 180F.
  • Column 4 – is the amount of time the HFH food must stay at the temperature indicated in Column 3.  This is usually minutes, so check the box “minutes”.  If the process authority said to invert food container and hold 1 minute; then right-side-up and hold 1 minute (the total time equals 2 minutes).  Write in 2.00 in the box below “minutes”.
  • Column 6 captures the scientific data that the process authority (PA) provides.  It is best not confuse this with processing time and temperature.  Just enter the data.  In almost all cases the “Other F” box is checked.  Write in the values provided by your PA for Ref T, Z, and below that: minutes (t).
  • Lastly, Column 11 is for Other factors.  If the processing time and temperature provided by your PA is valid only for a specific pH range, it will be indicated here.

(from FDA) May 16, 2018

A new section of the FDA Data Dashboard has been launched to help importers and manufacturers/processors meet supply-chain requirements under the FDA Food Safety Modernization Act (FSMA) by helping them more easily find compliance and enforcement information related to specific firms. Three of the FSMA rules contain supply-chain requirements: the Foreign Supplier Verification Programs rule, the Preventive Controls for Human Food rule, and Preventive Controls for Animal Food rule.

The Foreign Supplier Verification Programs rule requires importers to perform risk-based activities to verify that their suppliers are meeting applicable U.S. food safety standards. One such activity is an evaluation of a supplier’s performance and the risk associated with the food, a process that includes evaluating a supplier’s compliance with FDA regulations such as whether the supplier is subject to an FDA warning letter, import alert, or other FDA compliance action related to food safety. The Preventive Controls rules require manufacturers/processors to perform supplier approval if the ingredient supplied contains a hazard requiring a supply-chain applied control. Supplier approval includes consideration of the supplier’s compliance with food safety laws and regulations.

To assist with the evaluation process, FDA created a Supplier Evaluation Resources page to help importers and manufacturers/processors find relevant compliance and enforcement information for their suppliers, but that page required them to search multiple data bases.

The FDA has improved the Supplier Evaluation Resources page, which is now available as a new section in FDA’s Data Dashboard. The Data Dashboard brings all the information from the Supplier Evaluation Resource page together, allowing importers and manufacturers/processors to search multiple data bases at the same time. The dashboard can be used to find information regarding warning letters, import refusal, import alerts, and other firm-specific information with one search.

The FDA Data Dashboard was launched in 2014 to provide stakeholders with information on FDA’s compliance, inspection, and recall activities in an easy-to-read graphical format. The expansion of this platform to make it easier to search for purposes of fulfilling supply-chain requirements under the FSMA rules is one way FDA is working to help industry comply with the new food safety standards.

The FDA has made a final rule that “covered” retail and foodservice establishments must make calorie information available on their menus to help consumers make informed choices for themselves and their families.  The deadline for implementation is December 1, 2015. (UPDATE!!!! – The FDA has extended the compliance date to December 2016).

A covered establishment: (1) be part of a chain of 20 or more locations, (2) doing business under the same name, and (3) offering for sale substantially the same menu items.

Examples of restaurant-type foods that are covered when sold by a facility that is part of a chain with 20 or more locations include:

  • Meals from sit-down restaurants
  • Foods purchased at drive-through windows
  • Take-out food, such as pizza
  • Foods, such as made-to-order sandwiches, ordered from a menu or menu board at a delicatessen
  • Foods you serve yourself from a salad or hot food bar
  • Muffins at a bakery or coffee shop
  • Popcorn purchased at a movie theater or amusement park
  • A scoop of ice cream, milk shake or sundae from an ice cream store
  • Hot dogs or frozen drinks prepared on site in a convenience or warehouse store
  • Certain alcoholic beverages

Foods not covered include: foods purchased in grocery stores or other similar retail food establishments that are typically intended for more than one person to eat and require additional preparation before consuming, such as pounds of deli meats, cheeses, or large-size deli salads.

Covered establishments must (1) disclose calorie information on menus and menu boards for standard menu items; (2) post a succinct statement of a 2000 suggested daily caloric intake on menus and menu boards; and (3) post on menus and menu boards a statement that written nutrition information is available upon request.