Current through Register Vol. 42, No. 5, February 29, 2024
(1)
Adoption
by reference - The document entitled National Shellfish Sanitation
Program Guide for the Control of Molluscan Shellfish, 2017 Revision, Sections I
and II, promulgated by the U.S. Department of Health and Human Services, Public
Health Service, Food and Drug Administration, is hereby incorporated by
reference and made a part of this rule as if set out in full and all provisions
thereof are adopted as a rule of the State Board of Health.
(2)
Availability - Said document
is available at the office of Director, Division of Food, Milk, and Lodging,
RSA Tower Suite 1250, 201 Monroe Street, Montgomery, Alabama 36104 or online at
http://www.fda.gov/media/117080/download.
(3)
Control - Where there is
consistency between Chapter 420-3-18 and the National Shellfish Sanitation
Program Guide for the Control of Molluscan Shellfish, 2017 Revision, Section I
and II, these rules control. Where these rules are silent, the National
Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish, 2017
Revision, Sections I and II, controls.
(4) Water supply for permitted establishments
-
(a) The State Health Officer may sample a
shellfish processing establishment's water supply as often as necessary to
ensure compliance with these rules.
(b) When a water sample of a non-public water
system used by a shellfish processing establishment shows coliform present as
reported by the Alabama Department of Public Health Bureau of Clinical
Laboratories, a resample shall be taken within 7 days. Whenever two consecutive
samples taken on separate days show coliform present, the permit to operate
shall be suspended by the State Health Officer in accordance with appropriate
administrative procedures. A sample result of coliform absent with no confluent
growth is required prior to reinstatement of the permit.
(5) Harvest restriction times for control of
Vibrio bacteria -
(a) In order to control
growth of the bacteria Vibrio parahaemalyticus and Vibrio vulnificus, all
shellfish harvested for sale as shellstock (that is, for sale to the final
consumer as shellstock or half-shell service) shall be conducted within the
time limits specified in Appendix A for any month.
(b) For harvesting from private reefs, as
defined or designated by the Alabama Department of Conservation and Natural
Resources, the licensed shellfish harvester shall keep documentation noting the
time going onto, and coming off, the private reef. Each harvest container shall
be tagged when full with a completed, approved private lease tag purchased from
the Alabama Department of Conservation and Natural Resources. Total time from
first harvest until harvested shellfish are placed under approved mechanical
refrigeration shall not exceed the time limits specified in Appendix A for any
month, except as allowed in Rule 420-3-18-.08(5)(d).
(c) Any shellfish harvested outside the
designated harvest times, or without an approved time documentation to confirm,
or verify, the time limits of the shellfish harvest, shall be deemed
adulterated, except as allowed in Rule 420-3-18-.08(5)
(d).
(d) Shellfish harvested for
approved post-harvest processing to control Vibrio bacteria, or for sale to a
permitted shellfish processing facility for the purpose of shucking, and with
tags attached to the harvest container (bag, sack, or box) stating such
restricted use, shall be exempted from the time controls stated in Appendix A,
Column 3, of this rule. Nothing in this rule shall be deemed to exempt any
licensed shellfish harvester from a more restrictive harvest time that may be
set by the Alabama Department of Conservation and Natural Resources.
(e) If shellfish are received by a permitted
shellfish processing facility with "Restricted Use" information on any tag or
label attached to the shellfish container (bag, sack, or box), then the
shellfish in that container shall be processed and sold in accordance with the
attached "Restricted Use" information. The permitted shellfish processing
facility receiving the shellfish shall document in the facility's Hazard
Analysis Critical Control Point (HACCP) Plan that all further processing in the
facility was done in accordance with the "Restricted Use"
instructions.
(6)
Transportation -
(a) Shellstock for
commercial use and with a dealer tag attached stating "Keep refrigerated," or
similar language on the dealer tag indicating temperature maintenance is
required, shall be transported in refrigerated equipment as defined in these
rules, and the internal temperature of the shellstock meat shall be maintained
at 45°F or below.
(b) A
shellfish processing establishment may transport shellstock from one permitted
shellfish processing establishment to another permitted shellfish processing
establishment within short distances, and use alternate temperature maintenance
such as ice and adequate protection from contamination, if such transport is
made a part of the shellfish processing establishment's HACCP Plan and is
approved by the State Health Officer prior to any shellstock
transport.
Original Rule 420-3-18-.08 -
Appeals was repealed and rule .09 was
renumbered to .08 as per certification filed July 23, 2012; effective August
27, 2012.
Authors: Lewis A. Byrd, Ph.D., Christine
Collins, Jeff McCool, Greg Dunn, Byron Webb
Statutory Authority:
Code of Ala.
1975, §§
9-12-126,
22-2-2(6),
22-20-5.
