21 CFR § 507.5 - Exemptions.

§ 507.5 Exemptions.

(a) This part does not apply to establishments, including “farms” (as defined in § 1.227 of this chapter), that are not required to register under section 415 of the Federal Food, Drug, and Cosmetic Act.

(b)

(1) Subparts C and E of this part do not apply with respect to activities that are subject to § 500.23 and part 113 of this chapter (Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers) at an animal food facility if you are required to comply with, and are in compliance with, part 113 of this chapter with respect to those activities.

(2) The exemption in paragraph (b)(1) of this section is applicable only with respect to those microbiological hazards regulated under part 113 of this chapter.

(c) Subparts C and E of this part do not apply to activities of a facility that are subject to section 419 of the Federal Food, Drug, and Cosmetic Act (Standards for Produce Safety).

(d) Except as provided in subpart D of this part, subparts C and E of this part do not apply to a qualified facility. Qualified facilities are subject to the requirements in § 507.7.

(e) For a farm mixed-type facility that is a small or very small business, subparts C and E of this part do not apply to on-farm packing or holding of processed animal food, and § 507.7 does not apply to on-farm packing or holding of processed animal food by a very small business, if the only packing or holding activities subject to section 418 of the Federal Food, Drug, and Cosmetic Act that the business conducts are the following low-risk packing or holding activity/animal food combinations - i.e.,packing (or repacking) (including weighing or conveying incidental to packing or repacking); sorting, culling, or grading incidental to packing or storing; and storing (ambient, cold and controlled atmosphere) of:

(1) Roughage products (e.g., alfalfa meal, entire plant meal, stem meal, pomace, and pulp);

(2)Plant protein meals (e.g., algae, coconut (copra), guar, and peanut);

(3) Grain by-products and processed grain products (e.g., bran, flour, germ meal, grits, groats, hominy feed, malt sprouts, middlings, pearled grain, polished grain, brewers grain, distillers grain, and gluten meal);

(4) Oilseed products (e.g., oil and meal of safflower, soybean, or sunflower);

(5) Molasses (e.g., processed sugar cane, sugar beets, and citrus);

(6) Animal protein meals (e.g., blood, feather, meat, meat and bone, and marine (e.g., crab, fish, shrimp));

(7) Milk products (e.g., casein, cheese rind, and lactalbumin);

(8) Animal tissue-derived products (e.g., fat);

(9) Vitamins, minerals, and concentrates;

(10) Processing aids (e.g., enzymes, preservatives, and stabilizers); and

(11) Any other processed animal food that does not require time/temperature control for safety.

(f) For a farm mixed-type facility that is a small or very small business, subparts C and E of this part do not apply to on-farm manufacturing/processing activities conducted by a small or very small business for distribution into commerce, and § 507.7 does not apply to on-farm manufacturing/processing activities conducted by a very small business for distribution into commerce, if the only manufacturing/processing activities subject to section 418 of the Federal Food, Drug, and Cosmetic Act that the business conducts consists of the following low-risk manufacturing/processing activity/animal food combinations:

(1) Chopping or shredding hay;

(2) Cracking, crimping, flaking, pearling, peeling, shelling, or wafering - grain (e.g., barley, sorghum, corn, oats, rice, rye, and wheat) or oilseed (e.g., beans, canola, cottonseed, linseed, soybeans, and sunflowers);

(3) Crushing, dry rolling, grinding, milling, pulverizing - grain, oilseed, grain by-products and processed grain products, oilseed products, hay, ensiled material, culled fruits and vegetables, roughage (e.g., cobs, hulls, husks, and straws), or roughage products;

(4) Ensiling (including chopping, shredding, mixing, storing, or fermenting), that is, making silage or haylage from forage (e.g., sorghum (milo), corn (maize), alfalfa, and grass), grain, culled fruits and vegetables, or roughage;

(5) Extracting (mechanical) or wet rolling grain, oilseed, brewers grain by-products, or distillers grain by-products;

(6) Labeling roughage products, plant protein meals, grain by-products and processed grain products, oilseed products, molasses, animal protein meals, milk products, animal tissue-derived products, vitamins, minerals, concentrates, processing aids, finished animal food, including animal food ready for consumption, or any other processed animal food that does not require time/temperature control for safety; and

(7) Packaging roughage products, plant protein meals, grain by-products and processed grain products, oilseed products, molasses, animal protein meals, milk products, animal tissue-derived products, vitamins, minerals, concentrates, processing aids, finished animal food, including animal food ready for consumption, or any other processed animal food that does not require time/temperature control for safety.

(g) Subparts C and E of this part do not apply to facilities that are solely engaged in the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing.

(h)Subpart B of this part does not apply to any of the following:

(1) Establishments solely engaged in the holding and/or transportation of one or more raw agricultural commodities;

(2) Establishments solely engaged in hulling, shelling, drying, packing, and/or holding nuts and hulls (without manufacturing/processing, such as grinding shells or roasting nuts); and

(3) Establishments solely engaged in ginning of cotton (without manufacturing/processing, such as extracting oil from cottonseed).

[80 FR 56337, Sept. 17, 2015, as amended at 81 FR 3717, Jan. 22, 2016]