Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 500.000 - Good Manufacturing Practices For Food
Supplemental Regulations for Fish and Fishery Products
Section 500.020 - General Requirements

Universal Citation: 105 CMR 500.000 MA Code of Regs 500.020

Current through Register 1531, September 27, 2024

(A) Permit Requirements. No person shall operate as a wholesale seafood dealer, retail seafood dealer, or wholesale seafood truck 3 without a valid permit issued jointly by the Department and the Division of Marine Fisheries. No person shall operate as such a dealer in violation of applicable laws or in violation of any of the requirements specified in 105 CMR 500.000.

(B) Explanation of Permit Categories, Additional Requirements, and Restrictions.

(1) Wholesale Dealer .
(a) Allows the permit holder to acquire, handle, store, distribute, process, fillet, ship, and sell raw seafood products, whether frozen or unfrozen, in bulk or for resale from a single, fixed location;

(b) Allows the purchasing of seafood products from a harvester or commercial fisherman;

(c) Allows retail sales from a single, fixed location;

(d) Requires an inspection and approval from the Department before initial permitting; and

(e) The wholesale dealer is prohibited from engaging in any activity not specifically inspected for and approved by the Department, and endorsed on the permit.

(2) Retail Dealer.
(a) Allows the sale of raw fish, whether frozen or unfrozen, shellfish and crustaceans, at one fixed retail location;

(b) Allows the purchase of shellfish from an appropriately permitted wholesale dealer or wholesale truck, or from a certified interstate shellfish shipper;

(c) Allows the purchase of seafood except shellfish directly from a commercial fisherman;

(d) Prohibits high hazard processing, such as shucking and meat picking, and prohibits wet storing, re-labeling, and repacking of seafood;

(e) Prohibits removing shellfish meats from the shell. Shellfish meat prepared and served "on the half-shell" is permitted as authorized by written policy of the Department;

(f) Requires compliance with 105 CMR 590.000: State Sanitary Code Chapter X - Minimum Sanitation Standards for Food Establishments;

(g) Requires that proper shellfish tags must be attached to each container and requires the retention of tags for 90 days; and

(h) Requires an inspection by the local board of health and approval from the Department for initial permitting.

(3) Wholesale Truck.
(a) Allows the permit holder to acquire, handle, distribute, ship, and sell from the permitted truck raw seafood, whether frozen or unfrozen, in bulk or for resale only;

(b) Allows the purchase of finfish, crustaceans, and other non-molluscan shellfish seafood products directly from a commercial fisherman;

(c) Prohibits the holder from processing, re-labeling, or repacking seafood, and prohibits storing of seafood on the vehicle;

(d) Prohibits the holder from purchasing shellfish directly from anyone other than a wholesale dealer; and

(e) All wholesale trucks operating in Massachusetts require a separate inspection and approval from the Department.

(C) Permit Procedures.

(1) Application. Any person seeking to operate as a wholesale seafood dealer, a retail seafood dealer, or a wholesale seafood truck within Massachusetts shall submit an application for a permit to the Division of Marine Fisheries.
(a) The application shall be on a form provided by the Division of Marine Fisheries.

(b) No permit shall be issued prior to an inspection by and written approval from the Department, except that in the case of a retail dealer permit, an inspection and approval by the local board of health shall suffice.

(c) A copy of an approved inspection report must be submitted by the applicant to the Division of Marine Fisheries prior to the issuance of a permit.

(2) A permit shall be valid only for the activities and products inspected and approved by the Department and endorsed on the permit by the Division of Marine Fisheries, and only for the specific location indicated on the permit.

(3) A permit holder shall notify the Department in advance of any intention to change endorsed products or activities. Upon notification, the Department shall inspect the facility to verify compliance with applicable regulations, except that in the case of a retail dealer permit, an inspection by the local board of health shall suffice. No new product may be sold or new activity commenced until the facility is inspected and approved by the Department, and endorsed by the Division of Marine Fisheries for such product or activity.

(4) A permit may be renewed by applying at least 30 days prior to the expiration of the permit. Application for renewal shall be made in writing on a form provided by the Division of Marine Fisheries.

(5) Suspension or Revocation of Permit. The Department may suspend or revoke a permit for the reasons specified in 105 CMR 500.207 and pursuant to the procedures specified in 105 CMR 500.208.

(D) License Requirements. Pursuant to M.G.L. c. 94, § 305C, no person shall cook, smoke, or otherwise process seafood, or combine seafood with non-seafood ingredient(s), for sale at wholesale, without a valid license issued by the Department.

(E) Additional Storage and Transportation Requirements for Frozen and Refrigerated Seafood.

(1) Any facility used to store seafood shall comply with the requirements of 21 CFR Part 110 : Current Good Manufacturing Practice in Manufacturing, Packaging, or Holding Human Food.

(2) Any vehicle engaged in the wholesale transportation of seafood products shall have the name of the company and permit number clearly displayed on the two sides of its exterior. At a minimum, the lettering shall be four inches in height and of a color in contrast to the truck exterior.

(3) Vehicles used for the wholesale transportation of seafood shall not be used for any other food products without adequate separation and protection to avoid cross-contamination.

(4) Seafood products transported by a harvester or retail dealer shall be adequately protected from temperature abuse and environmental contamination. A retail dealer, transporting seafood products from a wholesale facility to the retail location, shall use mechanical refrigeration or ice from an approved source to maintain the product at an ambient temperature of 45° F (7.2° C), or below (or at a temperature required by other applicable law).

(5) When a wholesale dealer is also a master digger, separate vehicles are required for transporting shellfish from contaminated areas to the depuration facility and transporting depurated products for sale, unless the dealer adequately addresses the potential hazards in its HACCP plan (see105 CMR 500.020(G)) and SSOP.

(6) If a person holding a wholesale dealer permit or a wholesale truck permit leases a vehicle for 30 days or longer to transport seafood products, the person shall provide the Department and the Division of Marine Fisheries with the vehicle identification number and the registration number of the vehicle(s) leased. Any time a vehicle is added, removed or exchanged, the dealer shall notify the Department in writing and provide the new numbers, within ten business days of the change(s).

(F) All wholesale dealers and licensees shall comply with the following sections of federal regulation 21 CFR Part 123.00 : Fish and Fishery Products, to the extent they are applicable to the type of business conducted by the wholesale dealer or licensee.

(1) Subpart A - General Provisions, 21 CFR §§ 123.3 through 123.12;

(2) Subpart B - Smoked & Smoke-flavored Fishery Products, 21 CFR §§ 123.15 through 123.16; and

(3) Subpart C - Raw Molluscan Shellfish, 21 CFR §§ 123.20 through 123.28.

(G) Additional Hazard Analysis Critical Control Point (HACCP) Requirements. In addition to the record keeping requirements in 105 CMR 500.020(F) and 500.021(A), each wholesale dealer and licensee shall keep and maintain the following information:

(1) For those products for which it is determined that no hazard exists, a written justification in the form of a hazard analysis supporting that finding;

(2) A written Sanitation Standard Operating Procedure (SSOP);

(3) A written Corrective Action Plan for deviations from the HACCP plan or SSOP; and

(4) A written contingency plan for use in initiating and accomplishing a product recall in accordance with 105 CMR 500.005(K).

(H) Failure to Comply with HACCP Regulations. Failure of a wholesale dealer to comply with the HACCP requirements of 21 CFR 123.6(a) through (f) or 105 CMR 500.021(A), where applicable, may render the fish or fishery product(s) adulterated and/or may constitute a violation of 105 CMR 500.000.

(I) Finfish Operations in a Facility.

(1) Tanks used to chill large species of fish (tuna, swordfish, etc.) shall be constructed of materials that meet the requirements for a food-contact surface. The use of canvas or plastic tarps and wood construction is not permitted.

(2) Filleted fish shall be cooled to a temperature of 45°F (7.2°C) or less within two hours after packing, and shall be stored and shipped under conditions that will maintain such temperature.

(3) Filleting areas shall be equipped with a hand-wash sink supplied with adequate hot and cold running water and a three-compartment sink for ware washing.

(4) Mechanical pumps used to move water shall be constructed of food grade materials.

(5) All receptacles for waste or gurry shall be watertight and covered and shall be thoroughly cleaned after each emptying.

(6) Only clean refined food-grade salt or filtered brine of a temperature not exceeding 50°F (10.0°C) shall be used in the brining of fish.

(7) Only salt, sugar, wood smoke, vinegar, pure spices, spice flavoring, sodium benzoate, or other additives Generally Recognized as Safe (GRAS) by FDA may be used as fish preservatives.

(8) All processing activities, including but not limited to storing, thawing, filleting, packing, ice making, and fish washing shall be performed within the physical confines of the facility.

(J) Cooked Lobster Meat Processing/Meat Picking Operations .

(1) Picking Area. In facilities where the meat is removed from the animal, e.g. lobsters, crabs, whelks, urchins, etc., the room used for the picking shall be separated from other rooms or space in the building by a suitable full partition or walls. Doors to such rooms shall be equipped with self closing devices.

(2) The picking area shall be equipped with a hand-wash sink supplied with adequate hot and cold running water and a three-compartment sink for ware washing.

(3) Dead Lobsters. The use of dead lobsters, or parts thereof, for processing or sale for human consumption is strictly prohibited.

(4) Meat not immediately removed from the shell after cooking shall not be sold for human consumption unless it has been kept in a sanitary container and promptly refrigerated at 40°F (4.4°C) or less.

(5) Meats shall be cooled to a temperature of 40° F (4.4° C) or less within two hours after picking.

(K) Processing of Uncooked Frozen Shell-on Lobster Tails.

(1) A wholesale seafood dealer must be approved in writing by the Department and endorsed by the Division of Marine Fisheries prior to preparing and freezing uncooked lobster tails with shells on.

(2) The use of dead lobsters is strictly prohibited; the wholesale seafood dealer shall use only live lobsters killed specifically for this activity.

(3) Following separation of tails for freezing, the remaining portions of each lobster shall be processed by cooking within 30 minutes, or they must be discarded.

(L) Reduced Oxygen Packaging (ROP).

(1) Only refrigerated seafood that has one of the following safety barriers may be packaged in a reduced oxygen atmosphere:
(a) Water activity (aw) below.91;

(b) Acidity (pH) of less than 4.6;

(c) High levels of non-pathogenic competing organisms that prohibit the growth of pathogenic bacteria;

(d) Held at <= 38°F; or

(e) Frozen at 0°F except during processing, when for a maximum of two hours the product may exceed 0°F but shall not exceed 10°F.

(2) If refrigerated seafood has two or more of the barriers specified in 105 CMR 500.020(L)(1) (a) through (c) and (e), it may be held at <= 40°F.

(M) Bait Operations .

(1) The processing and storage of seafood for use as bait shall be conducted in areas separate from the processing and storage of seafood intended for human consumption. There shall be sufficient physical separation in place to protect food intended for human consumption from contamination by seafood intended for bait.

(2) Containers of bait product shall be plainly marked "BAIT" in red lettering no less than two inches in height. The word "BAIT" shall appear on a minimum of two sides and the top of each container.

(3) Seafood intended for bait shall not enter a facility, including loading dock areas, without the container having clear markings indicating the product's intended use.

3 A retail seafood truck requires a permit from the Division of Marine Fisheries and a permit from the local board of health under 105 cmr 590.000: State Sanitary Code Chapter X - Minimum Sanitation Standards for Food Establishments.

Disclaimer: These regulations may not be the most recent version. Massachusetts may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.