(a) No establishment may process or prepare fish, fish parts, or fish products capable of use as human food, or sell, transport, or offer for sale or transportation in commerce any of these articles without inspection under these regulations, except as expressly exempted in § 532.3.

(b) Inspection under the regulations is required at:

(1) Every establishment, except as provided in the regulation on exemption of retail operations (§ 532.3), in which any fish or fish products are wholly or in part, processed for transportation or sale in commerce, as articles intended for use as human food.

(2) Every establishment, except as provided in the regulation on exemption of retail operations (§ 532.3), within any State or organized territory which is designated pursuant to section 301 of the Act (21 U.S.C. 661), at which any fish or fish products are processed for use as human food solely for distribution within that State or territory.

(3) Except as provided in the regulation on exemption of retail operations (§ 532.3), every establishment designated by the administrator under section 301 of the Act (21 U.S.C. 661) as one producing adulterated fish products which would clearly endanger the public health.

(4) Coverage of fish and fish products processed in official establishments. All fish and fish products prepared in an official establishment must be inspected, handled, processed, marked, and labeled as required by the regulations.

(5) Other inspection. Periodic inspections may be made of:

(i) The records of all persons engaged in the business of hatching, feeding, growing, or transporting fish between premises where fish are bred, hatcheries, and premises where fish are grown, and from these premises to processing establishments.

(ii) Exempted retail establishments to determine that those establishments are operating in accordance with these regulations.