Processing and Distribution of Shellfish (216-RICR-50-10-6)

Regulation Authority:

R.I. Gen. Laws § 21-14-3

Purpose and Reason:

To update the date of the National Shellfish Sanitation Program’s Guide for Control of Molluscan Shellfish” from 2019 to 2023 referenced in the regulations and update the references to the FDA Food Code from 2017 to 2022.

The following changes are being proposed:

Universal - Changed “these regulations” to “this Part”

Universal - Changed he/his to they/their

Universal - Changed “must” to “shall”

§ 6.1.1 - Updated language to read “This Part is adopted pursuant to R.I. Gen. Laws § 21-14-3” and updated the date of the National Shellfish Sanitation Program’s Guide for Control of Molluscan Shellfish to 2023.

§ 6.1.2 - Updated language to read “This Part establishes minimum sanitary requirements for the conduct of molluscan shellfish business and the sanitary quality of shellfish sold and distributed to the public.”

§ 6.1.4 - Added incorporated reference section and incorporated the following:

• A) 21 C.F.R. § 123.6 (1997)
• B) 21 C.F.R. § 123 (2017)
• C) National Shellfish Sanitation Program’s Guide for Control of Molluscan Shellfish (2023)
• D) 21 C.F.R. § 161.130 (2017)
• E) Federal Fair Packaging and Labeling Act, 15 U.S.C. §§ 1451-1461 (1967)
• F) Jenkins, David, Joseph J. Connors, and Arnold E. Greenberg, Standard Methods for the Examination of Water and Wastewater. Washington, D.C: American Public Health Association (1981)

Added citations throughout the regulations.

§ 6.2(A)

Removed the following definitions:

• (8) ‘Critical deficiency’
• (20) ‘Key deficiency’
• (23) ‘Other deficiency’
• (33) ‘Secondary dealer’

Revised the following definitions:

• (7) ‘Critical control point’ reworded for clarity
• (11) ‘Director’ revised to read “means the Director of the Rhode Island Department of Health or their designee.”
• (15) – HACCP – Revised formatting for clarity
• (24) ‘Processing’ changed to a signpost to the statutory definition.
• (27) ‘Repacking shellfish’ changed to ‘Repacking’
• (31) ‘Shellfish business’ changed to a signpost to the statutory definition.

§ 6.3(B) - Changed “until that person shall have obtained a license from the Department” to “without a valid license issued by the Department”

• Removed "in some instances"

§§ 6.3(C) and (E) - Updated the date of 21 C.F.R. Part 123 to 2017

§§ 6.3(D) and 6.3.2(B) - Removed “the Act and”

§ 6.3(E) - Changed “wants to be” to “is seeking licensure as”

• Corrected date of reference to 2017.

§ 6.3(G) - Changed “January 1st” to “the first (1st) day of January”

§ 6.3.4(A) - Changed date of “National Shellfish Sanitation Program’s Guide for Control of Molluscan Shellfish” to 2023.

• Removed URL to the above-mentioned document

§ 6.4.1(A)(2) - Changed “licensing” to “a license”

§ 6.4.1(B)(1)(b) and (2) - Reworded for clarity.

§ 6.4.1(B)(2)(b)(5) - Removed hyperlink

§ 6.4.1(B)(2)(b)(6) - Changed “cross” to “across”

§ 6.4.1(B)(2)(b)(9) - Updated reference to the FDA Food Code to 2022 version.

§ 6.4.1(E)(1) - Updated reference to the FDA Food Code to 2022 version.

§ 6.4.1(E)(2) - Changed “this section of the Regulation” to “§ 6.4.1(E) of this Part.”

§ 6.4.1(E)(2)(a) - Added “number”

§ 6.4.1(E)(4) - Updated the date of 21 C.F.R. § 161.130

§ 6.4.1(E)(5)(a) - Changed “will” to “shall”

§ 6.4.1(E)(6)(b)(1) - Changed “number of the day of the year” to “Julian format or”

§ 6.4.1(E)(6)(b)(2) - Changed “include the year” to “the year should be added to the month and day of the month if using the non-Julian format”

§ 6.4.1(F) - Changed “dealer (SP, RP)” to “SP or RP”

§ 6.4.1(G)(2)(b) - Spelled out “Food and Drug Administration”

§ 6.4.1(G)(2)(c)(4) - Added “and”

§ 6.4.2(F)(3)(d) - Added “and,”

§ 6.4.2(I)(2)(b) - Changed “within” to “with”

§ 6.4.2(J) - Added “shall”

§ 6.4.2(J)(9) - Changed internal citation to point to the correct location

§ 6.4.3(D)(1)(b) - Moved “and,” to (c)

§ 6.4.3(F)(2)(c) - Added “and,”

§ 6.4.3(K)(4) - Changed “Health Department” to “the Department”

§ 6.4.4(B) - Added “or”

§ 6.4.4(E)(3) - Reworded for clarity

§ 6.4.4(G) - Removed “and,”

§ 6.4.4(H)(2)(a) - Moved “and,” to (b)

§ 6.4.4(J)(1)(l) - Changed “Authority” to “Department”

§ 6.4.4(K)(1)(a) - Moved “and,” to (b)

§ 6.4.5(A)(4) - Updated internal citation

§ 6.4.5(F)(1)(b) and (d) - Reworded for clarity

§ 6.4.5(F)(3)(c) - Added “and,”

§ 6.4.5(G)(3)(c)(3) - Added “and,”

§ 6.4.6(A)(1) - Changed date of FDA Model Ordinance from 2019 to 2023 and updated URL.

§ 6.4.6(E)(2) - Revised R.I. Gen. Laws citation

§ 6.4.7(B)(1)(b) - Added “that has:”

§ 6.4.8(A)(2) - Reworded for clarity

§ 6.4.11(B)(8)(a) - Changed “shellstock” to “shellfish”

§ 6.4.11(D)(2) - Reorganized section for clarity

§ 6.4.11(D)(3)(a)(6) - Changed date of National Shellfish Sanitation Program (NSSP) model regulations from 2019 to 2023.

§ 6.5(I) - Changed “Subchapter” to “Title”