The U.S. Department of Agriculture’s Animal and Plant Health Inspection Services (APHIS) has expressed “continued concern” about part of a draft regulation put forth by the European unio.

Veterinary Services officials at APHIS say their fears, first raised in 2017, relate to a list requirement for raw materials intended for use in the production of gelatin or collagen. They say it would unnecessarily impede exports of materials such as hides and bone chips from the United States.

These materials are not exported from sites that would be on a list for meat products as they are not under inspection of the Food Safety and Inspection Service (FSIS), so are not part of the official FSIS establishment that might be already listed on TRACES for food for human consumption.

TRACES is the European Commission’s online management tool for all sanitary requirements on trade and importation of animals, food, feed and plants.

Lists of third countries and regions that can import into the EU certain animals and goods intended for human consumption are established via previous legislation.

The draft European legislation sets new rules on food imported from non-EU countries. Requirements are based on the risks that certain foods may pose to public health. The purpose is to ensure that food from third countries complies with requirements in EU legislation or with rules recognized to be equivalent.

Raw milk, frogs’ legs, snails, live bivalve mollusks, fish products, sprouts and seeds for sprout production, and food containing plant and processed products of animal origin that are referred to as composite products are mentioned. Lists need to be established for reptile meat, insects, casings, rendered animal fats, and greaves, which are sometimes referred to as cracklings in the United States.

The draft states that to ensure compliance with food hygiene rules, products from sites manufacturing fresh, minced, meat preparations and products, mechanically separated meat and raw materials intended for production of gelatin or collagen, should only be allowed entry if establishments appear on lists drawn-up, updated and published by the European Commission. The raw materials such products are manufactured from should also come from establishments appearing on lists from the Commission.

APHIS officials said they understand it could take more than a month to add a new facility or amend existing approval on TRACES, which would unnecessarily impede trade. They also raised concerns about which list a facility needs to be on.

“(The) industries exporting these materials for the manufacture of gelatin/collagen for human consumption operate differently in the United States than the ones exporting meat and similar foods for human consumption,” the USDA sub-agency said in comments on the draft regulation.

“Their business model is far closer to that of animal by-products facilities that export these same materials (for other purposes) under Regulation (EU) 142/2011. APHIS has frequent changes to the list of eligible facilities. These facilities commonly change their names, or may choose to stop participating in our voluntary export verification program for commercial reasons. Indeed, facilities may only decide to become approved if they can take advantage of an immediate export opportunity.”

APHIS wants the Commission to allow exporting countries to enter and amend facility information in TRACES. That’s how it works for export of animal by-products to the EU and APHIS said the model has worked for years for those facilities and does not result in lengthy delays in changes to the approved establishment listing.

Regulation (EU) 2017/625 will replac the rules in areas covered by Regulation (EC) No 854/2004 and Regulation (EC) No 882/2004 from Dec. 14, 2019.

APHIS also commented in detail on another piece of draft regulation covering model certificates for animals and goods.

The agency expressed concerns that replacing a lost certificate with a new one that has a new number could facilitate fraud and an apparent new requirement that seal numbers may only be noted if the seal is placed under the “supervision” of the competent authority. APHIS is generally not present when products under its certification are loaded.