The person-in-charge: Shall ensure that shellfish are harvested, handled, and processed to meet the bacteriological standards in this regulation; and May not distribute shellfish that do not meet the standards in this regulation. 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. The bacteriological standards for shellfish are the following: Standard plate count (SPC) may not exceed 500,000 colony-forming units per gram of shellfish; 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 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. 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.