# 21 CFR § 108.19: Establishment of requirements for exemption from section 404 of the act

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-108.19

## Section

- **Citation:** 21 CFR § 108.19
- **Heading:** Establishment of requirements for exemption from section 404 of the act
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION > PART 108—EMERGENCY PERMIT CONTROL > Subpart A—General Provisions

## Text

(a) Whenever the Commissioner finds after investigation that the distribution in interstate commerce of any class of food may, by reason of contamination with microorganisms during the manufacture, processing, or packing thereof in any locality, be injurious to health, and that such injurious nature cannot be adequately determined after such articles have entered interstate commerce, he shall promulgate regulations in Subpart B of this part establishing requirements and conditions governing the manufacture, processing, or packing of the food necessary to protect the public health. Such regulations may be proposed by the Commissioner on his own initiative or in response to a petition from any interested person pursuant to part 10 of this chapter.
(b) A manufacturer, processor, or packer of a food for which a regulation has been promulgated in subpart B of this part shall be exempt from the requirement for a permit only if he meets all of the mandatory requirements and conditions established in that regulation.
[42 FR 14334, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977]

## Nearby sections

- [21 CFR § 108.3 § 108.3 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-108.3.md)
- [21 CFR § 108.5 § 108.5 Determination of the need for a permit.](https://www.frixlaw.com/law-library/statutes/ecfr-21-108.5.md)
- [21 CFR § 108.6 § 108.6 Revocation of determination of need for permit.](https://www.frixlaw.com/law-library/statutes/ecfr-21-108.6.md)
- [21 CFR § 108.7 § 108.7 Issuance or denial of permit.](https://www.frixlaw.com/law-library/statutes/ecfr-21-108.7.md)
- [21 CFR § 108.10 § 108.10 Suspension and reinstatement of permit.](https://www.frixlaw.com/law-library/statutes/ecfr-21-108.10.md)
- [21 CFR § 108.12 § 108.12 Manufacturing, processing, or packing without a permit, or in violation of a permit.](https://www.frixlaw.com/law-library/statutes/ecfr-21-108.12.md)
- [21 CFR § 108.19 § 108.19 Establishment of requirements for exemption from section 404 of the act.](https://www.frixlaw.com/law-library/statutes/ecfr-21-108.19.md)
- [21 CFR § 108.25 § 108.25 Acidified foods.](https://www.frixlaw.com/law-library/statutes/ecfr-21-108.25.md)
- [21 CFR § 108.35 § 108.35 Thermal processing of low-acid foods packaged in hermetically sealed containers.](https://www.frixlaw.com/law-library/statutes/ecfr-21-108.35.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-108.19. Check the current official text before relying on it. Not legal advice.