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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2020.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2020]
[CITE: 21CFR120.3]



Subpart A - General Provisions

Sec. 120.3 Definitions.

The definitions of terms in section 201 of the Federal Food, Drug, and Cosmetic Act, § 101.9(j)(18)(vi) of this chapter, and parts 110 and 117 of this chapter are applicable to such terms when used in this part, except that the definitions and terms in parts 110 and 117 do not govern such terms where such terms are redefined in this part and except that the terms facility, hazard, and manufacturing/processing in parts 110 and 117 do not govern such terms where used in this part. The following definitions shall also apply:

(a) Cleaned means washed with water of adequate sanitary quality.

(b) Control means to prevent, eliminate, or reduce.

(c) Control measure means any action or activity to prevent, reduce to acceptable levels, or eliminate a hazard.

(d) Critical control point means a point, step, or procedure in a food process at which a control measure can be applied and at which control is essential to reduce an identified food hazard to an acceptable level.

(e) Critical limit means the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food hazard.

(f) Culled means separation of damaged fruit from undamaged fruit. For processors of citrus juices using treatments to fruit surfaces to comply with § 120.24, culled means undamaged, tree-picked fruit that is U.S. Department of Agriculture choice or higher quality.

(g) Food hazard means any biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.

(h) Importer means either the U.S. owner or consignee at the time of entry of a food product into the United States, or the U.S. agent or representative of the foreign owner or consignee at the time of entry into the United States. The importer is responsible for ensuring that goods being offered for entry into the United States are in compliance with all applicable laws. For the purposes of this definition, the importer is ordinarily not the custom house broker, the freight forwarder, the carrier, or the steamship representative.

(i) Monitor means to conduct a planned sequence of observations or measurements to assess whether a process, point, or procedure is under control and to produce an accurate record for use in verification.

(j)(1) Processing means activities that are directly related to the production of juice products.

(2) For purposes of this part, processing does not include:

(i) Harvesting, picking, or transporting raw agricultural ingredients of juice products, without otherwise engaging in processing; and

(ii) The operation of a retail establishment.

(k) Processor means any person engaged in commercial, custom, or institutional processing of juice products, either in the United States or in a foreign country, including any person engaged in the processing of juice products that are intended for use in market or consumer tests.

(l) Retail establishment is an operation that provides juice directly to the consumers and does not include an establishment that sells or distributes juice to other business entities as well as directly to consumers. "Provides" includes storing, preparing, packaging, serving, and vending.

(m) Shall is used to state mandatory requirements.

(n) Shelf-stable product means a product that is hermetically sealed and, when stored at room temperature, should not demonstrate any microbial growth.

(o) Should is used to state recommended or advisory procedures or to identify recommended equipment.

(p) Validation means that element of verification focused on collecting and evaluating scientific and technical information to determine whether the HACCP plan, when properly implemented, will effectively control the identified food hazards.

(q) Verification means those activities, other than monitoring, that establish the validity of the HACCP plan and that the system is operating according to the plan.

[66 FR 6197, Jan. 19, 2001, as amended at 80 FR 56167, Sept. 17, 2015]