A. Legal Authority

• Federal Food Drug and Cosmetic Act, 21 U.S.C. 301 et seq.
• Food Safety Modernization Act of 2010, 21 U.S.C. 301 et seq. (amendments to FDCA)
• Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 121-134, 136 et seq.
• Title 21 CFR Parts 500 – 589, Animal Drugs, Feeds and Related Products
• Title 40 CFR Part 180, Tolerances and Exemptions from Tolerances from Pesticide Chemicals in or on Raw Agricultural Commodities

Information: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

B. Purpose

The purpose of the federal Food, Drug and Cosmetic Act (FDCA) is to protect the public from misbranded or adulterated food, drugs, and cosmetics. The Food Safety Modernization Act (FSMA) of 2010 made changes to the FDCA to shift the focus of federal regulations to preventing contamination through stricter controls and regulation, improved inspection services, and more scrutiny of imported foods, including seafood. The purpose of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) is to regulate the sale, distribution and use of pesticides in the U.S.

C. Applicability to Aquaculture

Aquacultured food products are subject to regulation by the Food and Drug Administration (FDA). The FDCA prohibits the addition of any poisonous or deleterious substance to food products in interstate commerce, unless permitted by the FDA. The jurisdiction of the FDA covers virtually all commercial aquaculture production. The regulatory scheme has three areas applicable to aquaculture: 1) food additives; 2) pesticide use on raw agricultural commodities; and 3) animal drugs used directly or in animal feed. For otherwise prohibited food additives which are required for food production or cannot be avoided, the FDA has established regulations as to the quantity and circumstances under which the substance can be used.

The FSMA imposes a number of mandates on individuals and entities that manufacture, process, pack, transport, distribute, receive, or hold articles of food. It broadens the FDA’s authority to regulate food facilities and would establish new requirements for those facilities. It also does the following: 1) provides FDA with mandatory recall authority (§206); 2) requires food companies to enhance due diligence on imported foods (§301); 3) provides food testing results to FDA (§202); 4) enacts Hazard Analysis and Critical Control Point (HACCP) programs (§103); 5) supplements food tracking recordkeeping; and 6) provides food industry employees with whistle-blower protection (§402). It exempts some farms and small businesses from some of the new regulatory requirements, and imposes fees on a limited number of FDA services/functions such as recalls, re-inspections, and export certifications (§207). Pesticides applied to raw agricultural products are regulated by the FIFRA. The standards concerning allowable quantities of regulated pesticides are found at 40 CFR Part 180. Drugs for use on animals used for food and used in animal feed must be approved by the FDA (21 CFR, Parts 500 to 589).

D. Administering Agency

U.S. Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993
Phone: 888-463-6332
Web site: http://www.fda.gov/ http://www.fda.gov/SiteMap/default.htm

E. Information Requirements

Permits and approvals required for sale of food additives, pesticides, and animal drugs and feed would generally apply only to manufacturers. For example, in 1995 the FDA finalized a rule (21 CFR 123), “Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products,” that requires processors of fish and fishery products to develop and implement HACCP systems for their operations. HACCP creates a process control system that identifies where hazards might occur in the food production process and puts in place stringent actions to take to prevent hazards from occurring.

With respect to aquaculture producers, they are exempt from coverage. Treatment with carbon dioxide, bleeding, washing, and icing of otherwise unprocessed fish by the aquaculture producer is an integral part of the process of harvesting and getting the fish to market, and is, therefore, not considered to be processing. However, heading, gutting, or packaging of fish (e.g., retail or wholesale packages or cartons) performed by the aquaculture producer is considered processing, and would subject the producer to coverage under the regulations.

With respect to which activities of a molluscan shellfish harvester are exempt from the requirements of the seafood HACCP, a person is exempt from all provisions of 21 CFR, §123 if they engage in the activity of harvesting molluscan shellfish without otherwise processing the shellfish. The following harvesting activities are not considered to be processing:

• Temporarily holding shell stock in bulk, or in containers, in part of the same natural shellfish growing waters where harvested, where such holding is an integral part of the operation of getting the harvested product to market;
• Placing shell stock in containers as they are harvested;
• Placing shellfish shipping tags on containers or shell stock;
• Sorting or washing shell stock in the harvest area; and
• Transporting by the harvester of shell stock in a boat to a processing facility.

Specific standards, permits and approvals which may apply to the use of food additives, pesticides and animal drugs and feed are beyond the scope of this summary. Go to the federal FDA web site and state DOH web site with specific questions and guidance documents. The FDA regulations only apply if and when regulated substances are used by an operator. It is important, however, that the operator be aware of possible restrictions and regulations before engaging in production.

Importation of Non-domestic Aquatic Animals

Shellfish Sanitation Regulations

Sanitation Permit

A. Legal Authority

• Chapter 321-11, HRS, Department of Health
• Hawaii Public Health Regulations, Chapter 1-A, Food Service and Food Establishment Sanitation Code

B. Purpose

The purpose of the sanitation regulations is to provide minimum requirements for the handling, processing and serving of foods to protect the public health, safety and welfare.

C. Applicability to Aquaculture

The need for a sanitation permit will depend on the specific nature of the aquaculture operation. Any person operating a food establishment must obtain a permit (Art. 1, Sec. 5, PHR). A food establishment means any place or portion thereof, maintained, used, or operated for the purpose of storing, preparing, serving, manufacturing, packaging, transporting, or otherwise handling food at the retail or wholesale level. The term includes any place where food is served or provided to the public, with or without charge, regardless of whether the food is consumed on or off premises.

Food establishments include: fish markets, fish-processing plants, or facilities for the production, preparation for sale, packing, storage, sale or distribution of any food. If a company is only harvesting and wholesaling to a processor or other permitted facility, a sanitation permit may not be required. Concerned aquaculture operations should check with the Sanitation Branch directly regarding the applicability of the requirements to any specific operation.

D. Administering Agency

The Sanitation Permit is administered by the Department of Health, Sanitation Branch.

Sanitation Branch Department of Health
591 Ala Moana Boulevard
Honolulu, Hawaii 96813
Phone: 808-586-8000
Fax: 808-586-8040
Web site: https://health.hawaii.gov/ (See web site at main branch for neighbor island offices)

E. Information Requirements

Permit applications can be obtained from the Sanitation Branch and online. Information needed includes the establishment name and location and owners name. There will be an inspection of the facility to review compliance with appropriate regulations.

F. Sequence of Filing

An applicant must apply for a permit prior to beginning construction, extensive remodeling or conversion work. Operation can begin pending a permit decision so long as the application has been made to the department.

G. Cost

Each application for issuance or renewal of a food establishment permit shall be accompanied by a fee payment. The fees are based on the total number of food operations conducted within the establishment, e.g., receiving, cold storage, cooling, display, etc. (see §11-12-7, HAR to determine the appropriate fees). In addition, there is a charge of $200 for food establishment plan review for new construction and$150 for remodeling.