Current through Register Vol. 42, No. 11, August 30, 2024
(1)
Purpose. The criteria in these rules shall apply in determining
whether the facilities, methods, practices, and controls used in the
manufacture, processing, packing or holding of food are in conformance with, or
are operated or administered in conformity with, good manufacturing practices
to assure that food for human consumption is safe and has been prepared,
packed, and held under sanitary conditions.
(2)
Statutory Authority. The
State Board of Health is authorized to adopt and promulgate these rules under
and by virtue of the authority of Code of Ala. 1975,
§§
22-2-2(6),
22-2-5, and
22-20-5.
(3)
Definitions. For the
purposes of these rules:
(a)
Adulterated Food means any food that bears or contains any
poisonous or deleterious substance which may render it injurious to health; or
if it consists in whole or in part of any filthy, putrid, or decomposed
substance, or if it is otherwise unfit for food; or if it has been prepared,
packed, or held under insanitary conditions whereby it may have become
contaminated with filth, or whereby it may have been rendered injurious to
health; or if it is otherwise defined as adulterated under §402(A) of the
Food, Drug, and Cosmetic Act (21 USC §
342).
(b)
Board means the Board of
Health of the State of Alabama as defined by Code of Ala.
1975, §
22-2-1, or the State Health
Officer or his or her designee, when acting for the Board, or for the purposes
of these rules, the Alabama Department of Public Health's Bureau of
Environmental Services.
(c)
CFR means Code of Federal Regulations. Citations in this rule to
the CFR refer sequentially to the Title, Part, and Section numbers, such as
21 CFR
110.80 refers to Title 21, Part 110, Section
80.
(d)
Department
means the Alabama Department of Public Health.
(e)
Employee means the permit
holder, individuals having supervisory or management duties and any other
person working in a food-processing establishment.
(f)
Food means any raw, cooked,
or processed edible substance, ice, beverage or ingredient used or intended for
use or for sale, in whole or in part, for human consumption, or chewing
gum.
(g)
Food Processing
Establishment means a commercial food processing establishment, plant,
or operation that manufactures, packages, labels, or stores food for human
consumption and does not provide food directly to a consumer. The term does not
include a food service establishment or a retail food store in which such foods
are processed if:
1. The food items are sold
to, or sold from, no more than two other retail food establishments during the
annual period coinciding with the food permit issuance and expiration date,
and
2. The total value of food
sales to other retail establishments during the annual period coinciding with
the food permit issuance and expiration date is less than $25,000.00.
The term includes stand-alone ice manufacturing facilities that
require servicing by entering (walking inside) the ice manufacturing
facility.
(h)
Health Officer means the Health Officer, or his or her designee,
of the county or district in which the food-processing establishment in
question is located as provided in Code of Ala. 1975,
§
22-3-2.
(i)
Label means a display of
written, printed, or graphic matter upon the immediate container of any
article; and a requirement of these rules that any word, statement, or other
information appear on the label shall not be considered to be complied with
unless such word, statement, or other information also appears on the outside
container or wrapper, if any, of the retail package of such article, or is
easily legible through the outside container or wrapper.
(j)
Labeling means all labels
and other written, printed, or graphic matter upon any article or any of its
containers or wrappers, or accompanying such article.
(k)
Law includes federal, state
and local statutes, ordinances and rules.
(l)
Permit means the document
issued by the Health Officer which authorizes a person to operate a
food-processing establishment.
(m)
Person includes any individual, partnership, corporation,
association or other legal entity.
(n)
Person in Charge means the
individual present in a food-processing establishment who is the apparent
supervisor of the food-processing establishment at the time of inspection. If
no individual is the apparent supervisor, then any employee present is the
person in charge.
(o)
Potentially Hazardous Food means a food that requires temperature
control to limit pathogenic microorganism growth or toxin formation and
includes an animal food that is raw or heat-treated; a plant food that is
heat-treated or consists of raw seed sprouts, cut melons, or garlic-in-oil
mixtures that are not modified in a way that result in mixtures that do not
support pathogenic microorganism growth or toxin formation. The term does not
include a food that, due to any combination of intrinsic and extrinsic factors,
does not support the growth or toxin formation of pathogenic
microorganisms.
(p)
Priority
Category 1 Food Processing Establishment means any food processing
establishment producing foods that, in final packaged form, do not require
refrigeration to prevent growth of pathogenic microorganisms or do not require
a specialized process under 21 CFR 113, 114, 120, or 123 for food
manufacturing.
(q)
Priority
Category 2 Food Processing Establishment means an establishment which
manufactures a food product that:
1. In final
packaged form is a potentially hazardous food requiring refrigeration to
prevent growth of pathogenic microorganisms, or
2. Includes a specialized process for food
manufacturing or production required in 21 CFR Part 113 (thermally processed
low acid foods), 21 CFR Part 114 (acidified foods), 21 CFR Part 120 (Hazard
Analysis Critical Control Point [HACCP] plan required), or 21 CFR Part 123
(seafood HACCP plan required).
(r)
Priority Item means a
provision of these rules that, if in non-compliance, is likely to be a direct
cause of food adulteration, contamination, or illness. Priority item provisions
are listed in Appendix A.
(s)
Raw Agricultural Commodity means any food in its raw or natural
state, including all fruits that are washed, colored, or otherwise treated in
their unpeeled natural form prior to marketing. Fish and fishery products are
not to be considered as raw agricultural commodities.
(4)
Exclusions - Establishments
engaged solely in the harvesting, storage, or distribution of one or more raw
agricultural commodities, as defined in Rule
420-3-20-.01(k),
which are ordinarily cleaned, prepared, treated, or otherwise processed before
being marketed to the public for consumption, are not covered by the provisions
of these rules.