RULE 481-31.2 - Inspection standards for food processing plants

RULE 481-31.2. Inspection standards for food processing plants

The following are the inspection standards for food processing plants including food storage facilities.

(1) Definitions. For the purposes of this rule, the following definitions shall apply. The definitions of "food," "label," "labeling," and "dietary supplement" are as defined in 21 U.S.C. Section 321.

(2) Prohibited acts. The prohibited acts identified in 21 U.S.C. Section 331(a) to (f), (k), and (v) shall also be prohibited acts in Iowa.

(3) Stop sale. Any article of food that is adulterated or misbranded when introduced into commerce may be embargoed until such a time as the adulteration of misbranding is remedied or the product is destroyed. The action is immediate, but the licensee may appeal the decision following the process outlined in rule 481-30.11 (10A,137C,137D,137F).

(4) Standards for food. If a standard that has been adopted for a food is adopted pursuant to 21 U.S.C. Section 341 (2012), the standard shall be met.

(5) Adulterated food. See rule 481-31.3 (137D,137F).

(6) Misbranded food. A food shall be misbranded if it is found in violation of 21 U.S.C. Section 343 (2012).

(7) New dietary ingredients. New dietary ingredients shall comply with the process in 21 U.S.C. Section 350(b) (2012) or shall be deemed adulterated.

(8) Records. Records shall be made available at minimum to the extent required under 21 U. S.C. Section 373 (2012) for all interstate and intrastate food.

(9) Adoption of Code of Federal Regulations. The following parts of the Code of Federal Regulations (April 1, 2019) are adopted:

a. 21 CFR Part 1, Sections 1.20 to 1.24 and Subpart O, Sections 1.900 to 1.934(labeling).

b. 21 CFR Part 7, Sections 7.1 to 7.13 and 7.40 to 7.59 (guaranty and recalls).

c. 21 CFR Part 70, Sections 70.20 to 70.25 (labeling requirements for colors).

d. 21 CFR Part 73, Sections 73.1 to 73.615 (color additives exempt from certification).

e. 21 CFR Part 74.101 to 74.706 (listing of color additives subject to certification).

f. 21 CFR Part 81, general specifications and general restrictions for provisional color additives for use in foods, drugs, and cosmetics.

g. 21 CFR Part 82, Sections 82.3 to 82.706 (certified provisionally listed colors and specifications).

h. 21 CFR Part 100, Section 100.155 (specific provisions for salt and iodized salt).

i. 21 CFR Part 101, except Sections 101.69 and 101.108 (food labeling).

j. 21 CFR Part 102, except Section 102.19 (common or usual name for nonstandard food).

k. 21 CFR Part 104, nutritional quality guidelines for foods.

l. 21 CFR Part 105, food for special dietary use.

m. 21 CFR Part 106, except Section 106.120 (infant formula quality control procedures).

n. 21 CFR Part 107, except Sections 107.200 to 107.280 (infant formula labeling).

o. 21 CFR Part 108, Sections 108.25 to 108.35 (exceptions for when a permit is not required, acidified and thermal processing of low-acid foods packaged in hermetically sealed containers).

p. 21 CFR Part 109, unavoidable contaminants in food for human consumption and food-packaging material.

q. 21 CFR Part 110, current good manufacturing practice in manufacturing, packing or holding human food.

r. 21 CFR Part 111, current good manufacturing practice in manufacturing, packaging, labeling, or holding operations for dietary supplements.

s. 21 CFR Part 113, thermally processed low-acid food packaged in hermetically sealed containers.

t. 21 CFR Part 114, acidified foods.

u. 21 CFR Part 115, shell eggs.

v. 21 CFR Part 117, current good manufacturing practice and hazard analysis and risk-based preventive controls for human food shall apply, with the following exceptions:

(1) Qualified facilities, as defined in 21 CFR 117, shall not include food processing plants manufacturing foods for interstate commerce or for use as an ingredient to other foods.

(2) Warehousing operations located on the premises of residences that store food for sale directly to a consumer customer or at a farmers market shall comply with subparts A, B, and F of 21 CFR 117.

w. 21 CFR Part 118, production, storage and transportation of shell eggs.

x. 21 CFR Part 120, hazard analysis and critical control point (HACCP) systems (juice).

y. 21 CFR Part 123, fish and fisheries products (seafood).

z. 21 CFR Part 129, processing and bottling of bottled drinking water.

aa. 21 CFR Part 130, except Sections 130.5, 130.6 and 130.17, food standards: general.

ab. 21 CFR Part 131, milk and cream.

ac. 21 CFR Part 133, cheeses and related cheese products.

ad. 21 CFR Part 135, frozen desserts.

ae. 21 CFR Part 136, bakery products.

af. 21 CFR Part 137, cereal flours and related products.

ag. 21 CFR Part 139, macaroni and noodle products.

ah. 21 CFR Part 145, canned fruits.

ai. 21 CFR Part 146, canned fruit juices.

aj. 21 CFR Part 150, fruit butters, jellies, preserves, and related products.

ak. 21 CFR Part 152, fruit pies.

al. 21 CFR Part 155 (canned vegetables).

am. 21 CFR Part 156, vegetable juices.

an. 21 CFR Part 158, frozen vegetables.

ao. 21 CFR Part 160, egg and egg products.

ap. 21 CFR Part 161, fish and shellfish.

aq. 21 CFR Part 163, cacao products.

ar. 21 CFR Part 164, tree nut and peanut products.

as. 21 CFR Part 165, beverages.

at. 21 CFR Part 166, margarine.

au. 21 CFR Part 168, sweeteners and table syrups.

av. 21 CFR Part 169, food dressings and flavorings.

aw. 21 CFR Part 170, except Sections 170.6, 170.15, and 170.17, food additives.

ax. 21 CFR Part 172, food additives permitted for direct addition to food for human consumption.

ay. 21 CFR Part 173, secondary direct food additives permitted in food for human consumption.

az. 21 CFR Part 174, indirect food additives: general.

ba. 21 CFR Part 175, indirect food additives: adhesives and components of coatings.

bb. 21 CFR Part 176, indirect food additives: paper and paperboard components.

bc. 21 CFR Part 177, indirect food additives: polymers.

bd. 21 CFR Part 178, indirect food additives: adjuvants, production aids, and sanitizers.

be. 21 CFR Part 180, food additives permitted in food or in contact with food on an interim basis pending additional study.

bf. 21 CFR Part 181, prior-sanctioned food ingredients.

bg. 21 CFR Part 182, substances generally recognized as safe.

bh. 21 CFR Part 184, direct food substances affirmed as generally recognized as safe.

bi. 21 CFR Part 186, indirect food substances affirmed as generally recognized as safe.

bj. 21 CFR Part 189, substances prohibited from use in human food.

bk. 21 CFR Part 190, dietary supplements.

(10) Egg products processing plants. The department shall generally use the good manufacturing practices adopted in paragraph 31.2(9) "b", unless such practices are inconsistent with standards set by the United States Department of Agriculture, Food Safety and Inspection Service, in 9 CFR Parts 590-592, January 1, 2018. If the standards are inconsistent, the standards adopted in 9 CFR Parts 590-592, January 1, 2018, apply.

(11) Specific requirements for the manufacture of packaged ice. In addition to compliance with subrules 31.2(1) through 31.2(9), manufacturers of packaged ice must comply with the following:

a. Equipment must be cleaned on a schedule of frequency that prevents the accumulation of mold, fungus and bacteria. A formal cleaning program and schedule which include the use of sanitizers to eliminate microorganisms must be developed and used.

b. Packaged ice must be tested every 120 days for the presence of bacteria.

c. Plants that use a nonpublic water system must sample the water supply monthly for the presence of bacteria and annually for chemical and pesticide contamination as required by law.

This rule is intended to implement Iowa Code section 137F.2.

(ARC 1191C, IAB 11/27/2013, effective 1/1/2014 Amended by IAB April 1, 2015/Volume XXXVII, Number 20, effective 5/6/2015 Amended by IAB November 25, 2015/Volume XXXVIII, Number 11, effective 12/30/2015 Amended by IAB July 5, 2017/Volume XL, Number 01, effective 8/9/2017 Amended by IAB November 21, 2018/Volume XLI, Number 11, effective 1/1/19 Amended by IAB July 29, 2020/Volume XLIII, Number 3, effective 9/2/2020)