# COMAR Title 10 — Maryland Department of Health

## Subtitle 15 — Food

### Chapter 07 — Shellfish Sanitation

**Authority:** Health-General Article, §§18-102, 21-211, 21-234, 21-235, 21-304, 21-305, 21-321, and 21-346—21-350, Annotated Code of Maryland

**Administrative History:** Effective date: September 1, 1967

**Administrative History:** Amended effective December 1, 1970

**Administrative History:** Regulations .01—.12 amended effective May 26, 1976 (3:11 Md. R. 592)

**Administrative History:** Regulations .02—.06 amended as an emergency provision effective August 20, 1985 (12:19 Md. R. 1843); emergency status expired December 18, 1985

**Administrative History:** Regulations .02—.06 amended effective March 10, 1986 (13:5 Md. R. 543)

**Administrative History:** Regulation .03C amended as an emergency provision effective June 1, 1978 (5:12 Md. R. 964); adopted permanently effective September 22, 1978 (5:19 Md. R. 1445)

**Administrative History:** Regulations .01—.12 repealed and new regulations .01—.06 adopted effective November 6, 2006 (33:22 Md. R. 1733)

**Administrative History:** Regulation .01A amended effective November 17, 2008 (35:23 Md. R. 2013); October 16, 2009 (36:20 Md. R. 1528); November 14, 2011 (38:23 Md. R. 1421); January 6, 2014 (40:26 Md. R. 2164); October 12, 2015 (42:20 Md. R. 1265); January 2, 2017 (43:26 Md. R. 1445); August 26, 2019 (46:17 Md. R. 726); July 24, 2023 (50:14 Md. R. 593); February 2, 2026 (53:2 Md. R. 61)

**Administrative History:** Regulation .02B amended as an emergency provision effective June 1, 2011 (38:15 Md. R. 898); amended permanently effective August 22, 2011 (38:17 Md. R. 1012)

**Administrative History:** Regulation .02B amended as an emergency provision effective June 1, 2013 (40:13 Md. R. 1072); amended permanently effective September 30, 2013 (40:19 Md. R. 1547)

**Administrative History:** Regulation .04 amended effective November 17, 2008 (35:23 Md. R. 2013)

**Administrative History:** Regulation .04D amended effective October 16, 2009 (36:20 Md. R. 1528)

**Administrative History:** Regulation .04E amended as an emergency provision effective June 1, 2011 (38:15 Md. R. 898); amended permanently effective August 22, 2011 (38:17 Md. R. 1012)

**Administrative History:** Regulation .06 adopted as an emergency provision effective June 1, 2011 (38:15 Md. R. 898); adopted permanently effective August 22, 2011 (38:17 Md. R. 1012)

**Administrative History:** Regulation .06B amended as an emergency provision effective June 1, 2013 (40:13 Md. R. 1072); amended permanently effective September 30, 2013 (40:19 Md. R. 1547)

#### Regulation .01 Incorporation by Reference.

*COMAR 10.15.07.01*

In this chapter, the following documents are incorporated by reference:

A. National Shellfish Sanitation Program (NSSP) Guide for the Control of Molluscan Shellfish 2023 Revision (US Food and Drug Administration), Section I. Purpose & Definitions and Section II. Model Ordinance except for Chapter IV, Shellstock Growing Areas; and

B. American Public Health Association, Recommended Procedures for the Examination of Sea Water and Shellfish, 4th Edition, 1970.

#### Regulation .02 Definitions.

*COMAR 10.15.07.02*

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

  (1) “Dealer” means a person who is issued a certificate by the Department for the activities of shellstock shipper, shucker-packer, repacker, reshipper, or depuration processor.

  (2) “Department” means the Maryland Department of Health or the Department's designee.

  (3) “Mechanical refrigeration” means the removal of heat by using a refrigerant subjected to cycles of refrigerating thermodynamics and employing a mechanical compressor.

  (4) Person-in-Charge.

    (a) “Person-in charge” means the licensee or other person responsible for the operation of the shellfish plant.

    (b) “Person-in-charge” includes the dealer as used in the National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish, Model Ordinance.

  (5) Shellfish Aquaculture Harvester Permittee.

    (a) “Shellfish aquaculture harvester permittee” means a person who is issued a permit by the Department of Natural Resources in accordance with COMAR 08.02.23.04 to harvest shellfish from a submerged land lease or water column lease.

    (b) “Shellfish aquaculture harvester permittee” includes a person registered to harvest shellfish from the lease cited on a shellfish harvester aquaculture permit.

  (6) “Temperature control” means the management of the temperature of shellstock by means of ice, mechanical refrigeration, or other approved means necessary to lower and maintain the temperature of the shellstock to 50°F (10°C) or below.

#### Regulation .03 Compliance with Other Chapters.

*COMAR 10.15.07.03*

A. The person-in-charge shall ensure that shellfish are processed and the facilities and equipment of a shellfish plant are designed, operated, and maintained in compliance with:

  (1) This chapter;

  (2) COMAR 10.15.04 and 10.15.10; and

  (3) The National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish, Model Ordinance.

B. If a conflict occurs between the requirements of this chapter and COMAR 10.15.04 or 10.15.10 regarding shellfish plants or the processing of shellfish, this chapter takes precedence.

#### Regulation .04 Licenses and Certifications.

*COMAR 10.15.07.04*

A. Except for a licensed harvester delivering the harvester's catch to a certified dealer on the day of harvest, a person may not offer shellfish for sale in-State or interstate unless the person is licensed and certified in accordance with this chapter.

B. In order to operate a shellfish plant, a person shall obtain a food processing plant license pursuant to the provisions of:

  (1) Health-General Article, §21-305, Annotated Code of Maryland;

  (2) COMAR 10.15.04; and

  (3) This chapter.

C. The person-in-charge shall ensure that:

  (1) Shellfish are not purchased, sold, or processed without the:

    (a) License required by the Health-General Article, §21-305, Annotated Code of Maryland; and

    (b) Certification required by this chapter; and

  (2) The required food processing plant license and certification are conspicuously posted in the plant.

D. In order to purchase or ship shellfish products in in-State or interstate commerce, a person shall obtain certification pursuant to this chapter.

E. The Department shall specify on the license and certification issued to a person operating a shellfish plant that the person is approved to operate as a:

  (1) Shucker-packer (SP);

  (2) Repacker (RP);

  (3) Shellstock shipper (SS);

  (4) Reshipper (RS); or

  (5) Depuration processor (DP).

F. The person-in-charge shall ensure that the operations in the plant are limited to the type of shellfish operation specified on the license and certification pursuant to §E of this regulation.

#### Regulation .05 Bacteriological Standards.

*COMAR 10.15.07.05*

A. The person-in-charge:

  (1) Shall ensure that shellfish are harvested, handled, and processed to meet the bacteriological standards in this regulation; and

  (2) May not distribute shellfish that do not meet the standards in this regulation.

B. To establish whether compliance is met with the bacteriological standards for shellfish in §C of this regulation, a person shall utilize the isolation, identification, and enumeration in the American Public Health Association Recommended Procedures for the Examination of Sea Water and Shellfish, or other methods approved by the Secretary based on the ability of the methods to provide accurate and repeatable results.

C. The bacteriological standards for shellfish are the following:

  (1) Standard plate count (SPC) may not exceed 500,000 colony-forming units per gram of shellfish;

  (2) Except when shellfish are further analyzed for Escherichia coli (E. coli), fecal coliform may not exceed 230 most probable number (MPN) per 100 grams of shellfish; and

  (3) When shellfish exceed 230 MPN fecal coliform per hundred grams and are further analyzed for E. coli, E. coli may not exceed 330 MPN per 100 grams of shellfish.

D. The Department shall construe numbers of bacteria in excess of the standards set forth in §C of this regulation as rendering the product adulterated, pursuant to Health-General Article, §21-207, Annotated Code of Maryland, and unfit for human consumption.

#### Regulation .06 Vibrio parahaemolyticus Control.

*COMAR 10.15.07.06*

A. A dealer and a shellfish aquaculture harvester permittee shall implement control measures as set forth in §B of this regulation to reduce the occurrence of Vibrio parahaemolyticus illness.

B. Control Measures.

  (1) From June 1 through September 30, a shellfish aquaculture harvester permittee shall:

    (a) Protect harvested oysters from direct sun by providing shade over the area where the harvested oysters are stored;

    (b) Maintain air flow to the area where the harvested oysters are stored;

    (c) Designate a single site for landing the harvested oysters;

    (d) Document the harvest start time, which is the time the first oysters are removed from the water, on a harvest trip record or harvest tag; and

    (e) Provide the harvest time record as set forth in §B(1)(d) of this regulation to a dealer on delivery.

  (2) From June 1 through June 30, a shellfish aquaculture harvester permittee shall deliver harvested oysters to a dealer by 11:30 a.m. on the day of harvest.

  (3) From July 1 through August 31, a shellfish aquaculture harvester permittee shall deliver harvested oysters to a dealer by 10:30 a.m. on the day of harvest.

  (4) From September 1 through September 30, a shellfish aquaculture harvester permittee shall deliver harvested oysters to a dealer by 12:30 p.m. on the day of harvest.

  (5) From June 1 through September 30, a dealer may not:

    (a) Receive oysters harvested from Maryland waters:

      (i) After the harvest delivery times set forth in §B(2)—(4) of this regulation; and

      (ii) Without a harvest time record as set forth in §B(1)(d) of this regulation; or

    (b) Sell or ship oysters that have not reached an internal temperature of 50°F (10°C) or below.

  (6) From June 1 through September 30, a dealer shall:

    (a) Place oysters under temperature control immediately upon delivery from the shellfish aquaculture harvester permittee: and

    (b) Implement a HACCP plan as defined in COMAR 10.15.04 that recognizes pathogen growth of naturally occurring Vibrio bacteria present from June through September 30 as a significant hazard and includes:

      (i) Control measures necessary to ensure, document, and verify that the internal temperature of oysters has reached 50°F (10°C) or below within 10 hours or less after being placed under temperature control; and

      (ii) Corrective action to ensure that oysters that are not cooled to an internal temperature of 50°F (10°C) within 10 hours are not directed to the raw shellfish market.

  (7) To comply with §B(6) of this regulation, a dealer shall ensure that a temperature control mechanism for cooling and storing of oysters:

    (a) Maintains a temperature of 45°F; and

    (b) Cools oysters to an internal temperature of 50°F (10°C) in 10 hours or less.

  (8) A shellfish aquaculture harvester permittee who is a dealer shall comply with the requirements set forth in §B(1)—(7) of this regulation.

  (9) The Department may except a shellfish aquaculture harvester permittee who is a dealer from the harvest delivery times set forth in §B(2)—(4) and the receiving time set forth in §B(5)(a)(i) of this regulation if the permittee/dealer:

    (a) Places harvested oysters under temperature control within 5 hours of harvest start time, which is the time the first oysters are removed from the water; and

    (b) Implements an HACCP plan as defined in COMAR 10.15.04 that includes the control measures necessary to ensure, document, and verify that the harvested oysters are placed under temperature control within 5 hours of harvest start time.