Does
each entry on USDA HACCP-generated records have to be signed and
dated?
9 CFR §417.5(b)
states that each entry on a record maintained under the HACCP
plan shall be made at the time the specific event occurs and
include the date and time recorded, and shall be signed or
initialed by the establishment employee making the entry.
9 CFR §417.5(c)
states that prior to shipping product, the establishment shall
review the records associated with the production of that
product to ensure that all critical limits were met and, if
appropriate, corrective actions were taken, including the
proper disposition of product. Where practicable, this review
shall be conducted, dated, and signed by an individual who
did not produce the record(s).
If
the establishment has slaughter and only simple processing,
is it necessary to have more than one HACCP plan?
No, it
is not necessary. It is acceptable for slaughter and simple
processing to be covered with the same plan. It is also considered
acceptable for these to be covered by separate plans.
Who
at our plant is required to receive HACCP training in order
to develop our plan, and what requirements of the USDA final rule
need to be fulfilled?
Only
one individual requires HACCP training to develop your plan.
As stated in 9 CFR §417.7 the individual must successfully complete
a course of instruction in the application of the seven HACCP
principles in meat or poultry processing, including a segment
on the development of a HACCP plan for a specific product
and on record review. An individual that is HACCP trained
but not an employee of your establishment can also help create
your plan.
The
Nutrition Labeling and Education Act of 1990 (NLEA) became
law on November 8, 1990 and has led to significant changes
in food labeling regulations. These regulations address three
primary areas: nutrition labels, nutrient content claims,
and health claims.
The
new nutrition labeling regulations in 21 CFR §101.9 require
nutrition labels on almost all packaged foods, revise the
list of nutrients whose content levels are required to be
shown on the nutrition label, adopt a new format for the nutrition
label, and provide for more consistent serving sizes across
product lines to reflect the amounts people actually eat.
The basic nutrition label is to list 14 nutrients. The nutrients
and the order in which they must be listed are as follows: calories,
calories from fat, total fat, saturated fat, cholesterol,
sodium, total carbohydrate, dietary fiber, sugars, protein,
vitamin A, vitamin C, calcium, and iron. Other vitamins and
minerals for which Reference Daily Intakes (RDI's) have been
established must be declared if a claim is made about them
or if they have been added as a nutrient supplement.
In
addition to these mandatory nutrients, manufacturers may voluntarily
choose to include calories from saturated fat and amounts
of polyunsaturated fat, monounsaturated fat, potassium, soluble
fiber, insoluble fiber, sugar alcohol, other carbohydrates,
other vitamins and minerals for which RDIs have been established,
and beta-carotene (as a percent of vitamin A). The amounts
of nutrients declared in nutrition labels are for the product
in the package, before consumer preparation. However, when
foods are not intended to be consumed as packaged, manufacturers
are encouraged to add another column of information specifying
the percent Daily Value of a serving of the food "as consumed."
What
are FDA requirements regarding Nutrient Content Claims?
Nutrient
content claims are those claims that describe the amount of
a nutrient in the food (such as "sodium free" or "low fat").
These claims may not be made unless they are defined by FDA
in regulations. General provisions for the use of nutrient
content claims have been established in 21 CFR §101.13. Specific
regulations have been issued that define the use of the terms
"good source," "high," and "more" (21 CFR §101.54) and the
terms "light" or "lite" (21 CFR §101.56). Separate regulations
also cover the use of nutrient content claims for caloric
content (21 CFR §101.60); sodium content (21 CFR §101.61); and
fat, fatty acid, and cholesterol content (21 CFR §101.62).
Various synonyms have also been established for the basic
terms. Persons considering using nutrient content claims on
the label or labeling of their products should refer to the
above regulations for details on the requirements.
"Food
additives" are substances which may by their intended uses
become components of food, either directly or indirectly,
or which may otherwise affect the characteristics of the food.
The term specifically includes any substance intended for
use in producing, manufacturing, packing, processing, preparing,
treating, packaging, transporting, or holding the food, and
any source of radiation intended for any such use under §201(s).
But
the law excludes the following from the definition of a "food additive":
Substances
generally recognized as safe by qualified experts.
Substances
used in accordance with a previous approval ("prior sanction")
under either the Federal Food, Drug, and Cosmetic Act, the
Poultry Products Inspection Act (21 U.S.C. 451) or the Federal
Meat Inspection Act (21 U.S.C. 601).
Pesticide
chemicals in or on raw agricultural products.
Color
additives.
New
animal drugs.
(Note:
pesticide chemicals, color additives, and new animal drugs
are subject to similar safety requirements of other sections
of the law).
Manufacturers
or importers not certain whether the chemicals or other ingredients
used in their foods are subject to the safety clearance requirements
of the Federal Food Drug Cosmetic Act (FFDCA) may seek an
opinion from the Food and Drug Administration. If premarket
approval is required, this may mean that studies, including
animal feeding tests, will have to be carried out in accordance
with recognized scientific procedures and the results submitted
to the Food and Drug Administration for evaluation. General
principles for evaluating the safety of food additives are
published in 21 CFR §170.20. General instructions for preparing
a food additive petition are in 21 §CFR 171.
What is the Food Allergen Labeling and Consumer Protection Act of 2004?
The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) was enacted in August 2004 and addresses, among other issues, the labeling of foods that contain certain food allergens. All packaged foods regulated under the Federal Food, Drug, and Cosmetic Act (FFD&C Act) that are labeled on or after January 1, 2006 must comply with FALCPA's food allergen labeling requirements. Under FALCPA, a "major food allergen" is an ingredient that is one of the following foods, is from one of the following food groups, or is an ingredient that contains protein derived from one of the following:
Who must establish and maintain records under The Bioterrorism Act?
Domestic persons (partnerships, corporations, associations, and individuals) that manufacture, process, pack, transport, distribute, receive, hold or import food; foreign persons that transport food in the U.S.; and persons who place food directly in contact with its finished container
