A frequent request for information made by members of the farming
community, besides information on organic farming and certification,
is adding value, in particular to meat products.
Any time you add value to a commodity, it falls into a totally
different category for regulations. And those regulations can be very
confusing. Even for those who are considered "experts", it's even
confusing. Doug Holt, Food Safety Specialist, presented at the Agribusiness
Counselors Training Session at the University of Missouri. Essentially,
the following is what those in attendance learned.
Regulations
Why are there regulations on value added products? Regulations help
to keep the truth straight for consumers. They protect the consumer
with safety issues and from fraud.
Who does the regulating? There are a number of agencies you would
need to be in contact with:
- USDA - The United States Department of Agriculture regulates raw
agricultural products. This would include meat sold at the wholesale
level, fresh fruits and vegetables and whole grains. Meat that is
sold direct from the farmer to the end consumer is not USDA regulated.
USDA also regulates processed meat products that contain greater than
2 percent meat as well as all sausages. USDA works in unison with
other allied agencies such as Food Safety and Inspection Service (FSIS)
and Animal and Plant Health Inspection Service (APHIS).
- FDA - The Food and Drug Administration regulates all processed foods.
Meat that is sold direct to the end consumer or from the wholesaler
on, is under FDA jurisdiction. They, too, work in contractual arrangements
with other allied agencies such as the MO Dept of Health and the local
county health departments.
- Federal Trade Commission
- Occupational Safety and Health Administration (workplace)
- Environmental Protection Agency
- Department of Commerce (weights and measures)
- Bureau of Alcohol, Tobacco and Firearms
What kinds of things do these agencies regulate?
- Production and processing conditions
- Sources of inputs
- Labeling and claims on labels
- Distribution and retail conditions
- Liability assignment
In general, USDA and EPA regulate production issues while the FDA regulates
processing issues and sources of inputs.
What power do these agencies have?
- They usually have a series of steps to punitive action such as on
the spot corrections, series of letters and warnings.
- FDA can place embargos and recalls on products as well as complete
shutdown of a processing facility.
- USDA will remove inspectors from complete shutdown processing facilities.
It is important to remember that regulations generally do not assure
quality of a product but rather regulations deal with safety of a product
and prevention of economic fraud to the consumer. The possible exception
is with USDA meat quality grades. Again, regulations are for safety
and fraud, not quality. So you need to be sure you have a quality product
that consumers will want to purchase before you go through all the hassles
of regulations.
United States Department of Agriculture
What does the USDA regulate? Remember that USDA regulates the production
process of raw commodities as well as processed meats and milk products
to the retail level. This includes:
- beef (veal), pork, lamb, goats
- poultry - chickens, turkeys and eggs
- milk and processed milk products (cattle, sheep, goats)
- The USDA is obligated to provide inspection for these species and
products, but will control the conditions of slaughter and further
processing
- meats prior to retail sale
The USDA does not regulate exotic species but they have the ability
to do so if you request them. A fee of $35/hour is charged to have a
USDA inspector on site. Exotic species include animals such as:
- rabbits and some other small mammals
- antelope, bison, deer, elk, reindeer, water buffalo
- ducks and other water fowl
- ratites (emu, ostrich, rhea)
The major regulations that the USDA covers are plant construction and
overall operation of the plant including good manufacturing practices
and HACCP requirements. They also regulate personnel, allowed ingredients
in a product, percentage of ingredients (standards of identity) and
labeling.
USDA labeling regulations include:
- Federal inspection mark termed in the industry as a bug
- The name of the product
- Ingredients list (if applicable)
- Identification of manufacturer or distributor
- Accurate statement of net contents
- Safety handling instructions (for raw products)
- Nutritional labeling (for some products)
USDA nutritional labeling requirements include:
- voluntary but encouraged for raw products
- small business exemptions available based on the dollar value of
sales
- generally follows the format of FDA regulated labels
USDA requires that labeling be pre-approved before it can be used in
retail sale. Usually a USDA regulated facility will have someone who
can help with label design and approval. There are expediters who can
help you with labeling review branch of the USDA.
Labeling definitions for USDA regulations do not allow a meat product
to be labeled "organic" but can be labeled as "certified organic by
...." (Jan 22, 1999). Examples include: not allowed - organic chicken
or organic beef. Allowable labeling - "beef" and elsewhere on the label
"certified organic by OCIA (or whichever certifying agency you choose).
To be labeled as natural there must not be any use of artificial ingredients
and minimal processing to the meat. Animal production claims, such as
no hormones (can be used with beef but not for pork or poultry) and
the term free range may also be used.
The USDA does not directly regulate meat after it leaves a USDA inspected
facility destined for retail; meat that is bought and sold among individuals
as the live animal; and meat that is processed by "custom exempt" processors
(the end user is the owner of the product).
To learn more about USDA regulations, contact:
Food and Drug Administration
What does the FDA regulate? They regulate all processed foods except
those containing significant amounts of meat, milk, or eggs, seafood
(including freshwater), all products at retail and the food service
industry.
Remember that the FDA regulates all processed foods. This includes
plant construction and operation to be sure the plant is using good
manufacturing practices and following HACCP requirements (seafood, voluntary
for food service); being sure that allowed ingredients are generally
recognized as safe; the percentage of ingredients (standards of identity)
and labeling.
The FDA regulates inspectable facilities. This includes construction
details such as walls, floors, ceilings, water source and equipment
as well as operational details and personnel.
When it comes to labeling, FDA requires a label to have the following:
- the name of the product
- ingredients list (if applicable)
- identification of manufacturer or distributor
- accurate statement of net contents
- nutritional labeling (for some products if going into retail store)
A label must meet FDA requirements but there is no pre-approval process
of the label before a product goes to retail as is required with USDA.
If you claim any of the following on a label, be prepared to show
the data that backs it up:
- content claims such as low, lite, high, rich, fat, sodium, calories
- health claims such as cancer, heart disease, birth defects, osteoporosis
- the FDA does not have as defined a stance on "value labeling" (all
natural, free range, organic, etc) as the USDA
Nutritional labeling for FDA
- required on all products except with small business exemption
- less than 100,000 units or less than 10 employees - ask per mission
- less than 10,000 units - no notification required
- required if claim is made
UPC codes (universal product codes) are not a government requirement,
but managed by a private company. They cost about $300 a year for the
initial code (based on estimated sales.) An incremental additional cost
is charged for each additional code in the same company. For more information
see: www.uc-council.org.
The FDA does not regulate anything the USDA regulates nor nutritional
supplements implied claims such as medicinal herbs.
To learn more about the FDA regulations, contact:
- MO Value Added Development Center, 573-882-1150
- Local Health Dept and ask for the "tan" book
- MO Dept of Health, Mary Fandrey, 573-751-6111
- FDA Small Business Representative in Dallas TX, 214-655-8100 ext
128
- FDA web site: www.fda.gov
Other resources: