Alabama Administrative Code › Title 420 - ALABAMA STATE BOARD OF HEALTH › Chapter 420-3-20 - FOOD PROCESSING ESTABLISHMENT SANITATION › Section 420-3-20-.01 - General Provisions

Current through Register Vol. 42, No. 9, June 28, 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.