A. Legal Authority

• Chapter 328, HRS, Food Drugs and Cosmetics
• Title 11, Chapter 35, HAR, Department of Health, Shellfish Sanitation
• U.S. Food, Drug and Cosmetic Act, 21 U.S.C. 301 et seq.
• National Shellfish Sanitation Program Manual of Operations, Public Health Service Publication Number 33, U.S. Department of Health and Human Services

Information:

• https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act
• https://www.fda.gov/media/143238/download
• https://health.hawaii.gov/opppd/files/2015/06/11-35.pdf
• https://files.hawaii.gov/dcca/pvl/pvl/hrs/hrs_pvl_328.pdf

B. Purpose

The purpose of these shellfish sanitation regulations is to establish sanitary controls for the shellfish industry. The provisions shall apply to the growing area and to all aspects of harvesting, processing, packaging, storing, and distributing of shellfish.

C. Applicability to Aquaculture

Culture of shellfish (e.g., oysters, clams, mussels) is an established industry on the U.S. Mainland and an emerging industry in Hawaiʻi. No person in the State of Hawaiʻi shall operate a plant or business engaged in growing, harvesting, shucking, packing, repacking, or reshipping fresh or fresh-frozen shellfish for sale to the public for human consumption without a valid permit issued by the Department of Health (DOH). Shellfish include all edible species of oysters, clams, and mussels of the molluscan class Pelecypoda, unless the product is in final packaging and has been heat-sterilized and packaged in hermetically sealed containers.

Shellfish growing areas (e.g., offshore ocean, coastal, estuarine or fresh water areas suitable for natural shellfish growth or artificial shellfish propagation) are surveyed, approved and classified by DOH. A survey evaluates all factors affecting the quality of the shellfish growing area, including sources of pollution, the effects of wind, tides, and currents, and the distribution and dilution of the polluting materials, and the bacteriological quality of water.

Areas not surveyed are automatically classed as prohibited areas. Shellfish from approved areas may be harvested for direct marketing. No person shall sell, transport, receive or take any shellfish not declared to be approved or otherwise fit for direct marketing.

Artificial growing systems for shellfish, e.g., a man-made system with definite boundaries in which shellfish are grown using supplemental materials, must meet the performance criteria for natural growing systems. The operator of an artificial growing system shall be issued a shell stock shipper’s certificate. Harvesting, processing, packing, storing and shucking operations must be approved and meet the standards set forth in the regulations.

Permits issued are valid for up to one year, with an automatic expiration date of June 30 of each year.

D. Administering Agency

Food and Drug Branch
Department of Health
591 Ala Moana Boulevard
Honolulu, Hawaiʻi 96813
Phone: 808-586-4725
Fax: 808-586-4729
Website: http://hawaii.gov/health/about/admin/health/environmental/food_drug/about.html

E. Information Requirements

Permit applications shall be accompanied by sufficient written data, drawings and descriptions for the department to evaluate the operation relative to the regulations. All collection and transportation of shellfish growing water samples and shell stock shall be performed in accordance with “Recommended Procedures for the Examination of Sea Water and Shellfish,” American Public Health Association, 4th edition, 1970. Analyses of these samples for bacteriological, toxicological, chemical, and physical parameters shall be performed by a laboratory approved by the DOH and in accordance with methods recommended in the regulations.

F. Public Participation

There is no requirement for public notice or participation in the decision.

G. Process Time

The regulations do not set forth any specific time frames for action on permit applications. However, sampling of proposed growing areas for classification will require a year or more of data for review by DOH.

H. Sequence of Filing

The permit must be obtained prior to conducting shellfish operations for sale of product to the public.

I. Cost

There is no filing fee associated with the permit application to sell shellfish. However, the application must have sufficient written data, drawings and descriptions for the department to evaluate the operation relative to the regulations. The cost of a Sanitary Survey to classify a natural growing area is the responsibility of the DOH. An artificial growing system must have a routine monitoring program by the certificate holder to assure proper functioning of the water system. This program shall include the monitoring of temperature, salinity, and fecal and total coliforms of source and effluent waters.