Jurisdictional overlap between FDA and USDA (US Food Regulation series: Part 4)

In the previous post entitled “US Food Law and Regulation Series: Part 1”, we focused our discussion on the different regulatory body Food and Drug Administration (FDA) , US Department of Agriculture’s Food Safety Inspection Service (USDA/ FSIS), CDC, NMFS, EPA, DHS etc and their interaction in the food safety regulation. In the second part of the series entitled “US Food Law and Regulation Series: Part 2”, we tried to discuss the issues in the definition of food, dietary supplements and drug. We also discussed the concept of “intended use” and how it can have impact on the definition. In the third part of the series entitled, "History of the regulation of dietary supplements (US Food Regulation series: Part 3)", we discussed about the problems and issues of dietary supplement regulation by FDA. The era of confusion on the regulation of dietary supplements ranged from 1906 till 1994, when FDA and manufacturers faced multiple incidences of court cases due to regulatory ambiguity and differences in understanding. It demanded for a separate DSHEA act in 1994 for the regulation of dietary supplement as food. Based on the discussion, we had concluded that single food and drug control agency is not a requirement for the regulation of dietary supplement. 

This is the fourth part of the series. In this post, we will focus our discussion on the "jurisdictional overlap between FDA and USDA". Food and Drug Administration (FDA) and the US Department of Agriculture’s Food Safety Inspection Service (USDA/ FSIS) are two primary food control agencies of US. We will try to evaluate the issues and challenges of having multiple food control agencies in a country.

Food Drug & Cosmetic act is a governing act to regulate food safety in US. However, there are jurisdictional overlap between FDA and USDA/FSIS. To reduce this overlap, series of guidelines and agreements between the agencies have been formulated. In some cases, the boundary is clear, while in many cases the line is arbitrary. This has created number of problems in the history.

In general, USDA through FSIS is responsible for regulating meat, poultry and egg products. However, there are areas of overlaps and confusion. Let’s take some examples:

1. A sausage product is regulated by both the FDA and USDA. The meat filling is regulated by USDA and the casing containing meat of no nutritional value is regulated by FDA.

2. The shelled eggs, chicken feed and egg labeling is regulated by FDA, while the egg products (liquid, dehydrated, frozen etc), the laying facilities, grading of eggs are regulated by USDA.

We can imagine the level of confusion it can create. A single food safety agency can provide a more cohesive approach. Facilities regulated by both the agencies are having difficulties fulfilling the requirements. For example, a chicken tomato soup making facility will be inspected by both the agencies. It creates confusion and overlapping of authorities during inspection, enforcement actions and carrying out the compliance programs.

Let’s try to compare the FDA and USDA jurisdiction  in the following table.

FDA jurisdiction	USDA jurisdiction
All non-specified red meats (bison, rabbits, game animals, zoo animals and all members of the deer family including elk (wapiti) and moose)), all non-specified birds including wild turkeys, wild ducks, and wild geese	Cattle, sheep, swine, goats, horses, mules or other equines, including their carcasses and parts, turkeys, ducks, geese and guineas, domesticated chicken, turkey, duck, goose or guinea.
Products with 3 % or less raw meat; less than 2% cooked meat or other portions of the carcass; or less than 30 % fat, tallow or meat extract, alone or in combination	Products containing greater than 3% raw meat; 2% or more cooked meat or other portions of the carcass; or 30% or more fat, tallow or meat extract, alone or in combination
Products containing less than 2% cooked poultry meat; less than 10% cooked poultry skins, giblets, fat and poultry meat (limited to less than 2%) in any combination	Products containing 2% or more cooked poultry; more than 10% cooked poultry skins, giblets, fat and poultry meat in any combination
Closed-face sandwiches	Open-face sandwiches
Shell eggs and egg containing products that do not meet USDA’s definition of “egg product.”	Dried, frozen, or liquid eggs, with or without added ingredients, but has many exceptions. The following products, among others, are exempted as not being egg products: freeze-dried products, imitation egg products, egg substitutes, dietary foods, dried no-bake custard mixes, egg nog mixes, acidic dressings, noodles, milk and egg dip, cake mixes, French toast, sandwiches containing eggs or egg products, balut and other similar ethnic delicacies. Products that do not fall under the definition, such as egg substitutes and cooked products, are under FDA jurisdiction
Egg processing plants (egg washing, sorting, packing)	Egg products processing plants (egg breaking and pasteurizing operations)
Cheese pizza, onion and mushroom pizza, meat flavored spaghetti sauce (less than 3 % red meat), meat flavored spaghetti sauce with mushrooms, (2% meat), pork and beans, sliced egg sandwich (closed-face), frozen fish dinner, rabbit stew, shrimp-flavored instant noodles, venison jerky, buffalo burgers, alligator nuggets, noodle soup chicken flavor	Pepperoni pizza, meat-lovers stuffed crust pizza, meat sauces (3% red meat or more), spaghetti sauce with meat balls, open-faced roast beef sandwich, hot dogs, corn dogs, beef/vegetable pot pie, Chicken sandwich (open face), chicken noodle soup

Are you confused? Even a technologist will get confused with the jurisdiction overlaps.

DFTQC is a single agency regulating food act in Nepal. Currently, we are not facing such problems in the regulation of food products. The approved food safety policy 2076 demands for even broader scope "from farm to fork". Out of sudden, the idea of FDA has flooded in Nepal, without consultation with the relevant ministry, department, professionals and stakeholders.

I hope the discussion on the jurisdictional overlap between FDA and USDA is a good learning. We can now imagine the scenario of presence of both DFTQC and "FDA" in Nepal.

Now, it’s time to ask questions ourselves: “Do we want to create similar jurisdictional overlap by creating multiple food control agencies in Nepal? Do we want to strengthen or weaken the existing system? Do we want to build up or break up the existing system?..... etc"

What's your opinion? 

“Let's learn from the mistakes of others, you can never live long enough to make them all yourself.”

……………….end of part 4

I will try to continue this series. Please provide your feedback in the comment box below. You are free to  agree or disagree with my argument.
Please keep in touch and follow this blog.

Related post to read
US Food Law and Regulation Series: Part 1
US Food Law and Regulation Series: Part 2

History of the regulation of dietary supplements (US Food Regulation series: Part 3)

Jurisdictional overlap between FDA and USDA (US Food Regulation series: Part 4)

Federal Inspections and Law Enforcement Tools used by FDA (US Food Regulation series: Part 5)

References
M. C. Sanchez, Food Law and Regulation for Non-Lawyers, Food Science Text Series, DOI 10.1007/978-3-319-12472-8_2, © Springer International Publishing Switzerland 2015