Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 500.000 - Good Manufacturing Practices For Food
Supplemental Regulations for Fish and Fishery Products
Section 500.021 - Additional Requirements for Handlers of Shellfish
Universal Citation: 105 CMR 500.000 MA Code of Regs 500.021
Current through Register 1531, September 27, 2024
All wholesale dealers and wholesale trucks that handle shellfish shall comply with 105 CMR 500.021.
(A) Requirements for wholesale dealers and wholesale trucks that handle shellfish shall be established as administrative guidelines by the Department, based on the National Shellfish Sanitation Program (NSSP) Model Ordinance (NSSP Model Ordinance), published by the United States Department of Health and Human Services and the Interstate Shellfish Sanitation Conference. All wholesale dealers and wholesale trucks that handle shellfish shall comply with the administrative guidelines.
(B) Shellfish Transactions.
(1) A harvester may
sell shellfish only to a Massachusetts wholesale dealer holding a permit
endorsed for shellfish issued by the Division of Marine Fisheries and the
Department. A harvester is prohibited from selling shellfish directly to a
retail dealer, wholesale truck, restaurant, or consumer.
(2) The direct sale of shellfish to a
consumer from a vehicle is prohibited, except as authorized by written policy
of the Department.
(3) Each
transaction between a harvester and a wholesale dealer shall be recorded on a
serialized transaction slip approved by the Department. Information recorded on
the transaction slip shall include the wholesale dealer's name and permit
number, the type and amount of shellfish purchased, date of purchase, and the
area from which the shellfish were harvested. Also, the transaction slip
documenting the purchase of shellfish shall be imprinted by the wholesale
dealer to show the number from the harvester's Shellfish Transaction Card
issued by the Division of Marine Fisheries.
(4) The wholesale dealer, master digger, and
harvester shall retain their copies of the transaction slip for at least 90
days.
(5) A wholesale dealer shall
purchase shellfish only from another wholesale dealer or from a harvester or
master digger who presents a Shellfish Transaction Card and who is either known
to the wholesale dealer or who presents photo identification.
(6) Sales of shellfish by a harvester to a
wholesale dealer shall only be conducted by:
(a) The harvester transporting his or her
product directly from the landing site to the wholesale dealer's physical
facility for sale; or
(b) The
harvester selling the product to an employee of a wholesale dealer at the
landing site, provided that the employee transports the product to the
wholesale dealer's facility. Shellfish purchased at the landing site must be
transported to the wholesale dealer's facility for washing, grading, and
tagging prior to its entering the marketplace.
(7) It is prohibited to land shellfish
without an approved tag attached to the container as described in the
Department's administrative guidelines based on the NSSP Model Ordinance.
Containers with improper tags or no tags are misbranded and subject to
embargo.
(8) Wholesale dealers
shall retain tags for a minimum of 90 days. Tags shall be maintained in an
orderly manner, e.g. chronologically, by harvester/dealer, or
in some other appropriate manner, which facilitates the tracking of dealer
purchases.
(9) Any commingling of
different lots of shellfish shall be conducted in conformance with written
Department policy.
(10) Dealers who
receive shellstock from harvesters whose commercial shellfishing permits are
subject to conditions imposed by the Division of Marine Fisheries or the
Department, including but not limited to the requirement of a Vibrio management
plan, or requirements related to participation in the Massachusetts Program for
Onboard Screening and Dockside Testing for PSP Toxins in Molluscan Shellfish in
Federally Closed Waters, shall comply with requirements of all plans or
memoranda of understanding related to such conditions. Failure to comply may
result in enforcement action, including coordination with the Division of
Marine Fisheries on appropriate enforcement.
(C) Clam Juice.
(1) Clam juice intended for human consumption
shall not be sold or offered for sale without first being pasteurized in a
manner and with equipment approved by the Department.
(2) A timer and thermometer shall be used to
insure that the product has been heated sufficiently to destroy pathogens.
Records of timer and thermometer calibration shall be maintained for one
year.
(D) Wet Storage.
(1) Wet
storage activities shall be conducted in accordance with the Department's
administrative guidelines based on the NSSP Model Ordinance.
(2) Wholesale dealers shall receive written
approval from the Department prior to conducting a wet storage
activity.
(E) Shucked Shellfish.
(1) Packing operations shall be conducted in
a room separated from other rooms in the facility by suitable full partitions
or walls.
(2) Doors to the packing
room shall be self-closing and tight-fitting.
(3) A shucked shellfish delivery window shall
be installed in the partition or wall to the packing room and shall be equipped
with a corrosion-resistant shelf that tilts away from the packing
room.
(4) The packing room shall be
equipped with a hand-wash sink, adequate hot and cold running water, and a
three-compartment sink for ware washing.
(5) The packing room shall be large enough to
permit the thorough cleaning of all equipment.
(F) Sanitary Standard for Shellfish Sold in Massachusetts.
(1)
Sanitary
Standard. Any shellfish, fresh or frozen, shall be deemed to meet
the sanitary standard for shellfish sold in Massachusetts if:
(a) It was harvested from an area approved by
the appropriate shellfish control agency, or it was harvested from a restricted
area and was subjected to a process of controlled purification ("depuration")
approved by the Department; and
(b)
It meets the Department's administrative guidelines based on the NSSP Model
Ordinance standards for fecal and pathogenic contamination.
(2)
Procedure when
Shellfish Do Not Comply with Sanitary Standard.
(a) When a sample of shellfish is not in
compliance with the sanitary standard specified in 105 CMR 500.021(F)(1), the
Department may re-sample or cause to be re-sampled shellfish from the same
source in order to verify the test result and attempt to ascertain the cause of
the problem.
(b) If upon
re-sampling and retesting, the shellfish again do not comply with the sanitary
standard, the Department may undertake one or more of the following:
1. Issue a warning notice to the person or
persons responsible for harvesting, handling, processing, or transporting the
shellfish and/or notify the responsible permitting authority;
2. Seize or embargo all shellfish from the
same lot as those that have been found not to comply with the sanitary
standard; and/or
3. Notify the
person or persons responsible for harvesting, handling, processing, or
transporting the shellfish that all future lots of shellfish from such person
or persons shall be subject to embargo.
(c) The embargo against all shipments
specified in 105 CMR 500.021(F)(2)(b)3. shall remain in effect until:
1. Test results obtained from sampling by the
Department from two consecutive lots of shellfish, harvested on different days,
indicate compliance with the sanitary standard; or
2. Test results obtained from sampling by the
responsible out of state shellfish control agency from two consecutive lots of
shellfish, harvested on different days, under time and temperature conditions
which duplicate transportation and delivery to Massachusetts, indicate
compliance with the sanitary standard.
3. In either case specified in 105 CMR
500.021(F)(2)(c)1. or 2., if the shellfish are to be shipped to Massachusetts
from out of state, the out of state shellfish control agency shall certify in
writing to the Department that the sources of contamination or handling
problems causing the failure of the shellfish to comply with the sanitary
standard have been identified and corrected.
(3)
Prohibition on Sale of
Shellfish in Massachusetts.
(a)
When the Commissioner of Public Health, upon the recommendation of the Program,
finds with respect to shellfish from a particular state or country, which
serves as a source of shellfish sold in Massachusetts, that:
1. There is evidence of substantial and
continuing noncompliance with the shellfish sanitary standard, or
2. Multiple notices of embargoes have been
issued pursuant to 105 CMR 500.021(F)(2)(b), or
3. Epidemiological evidence indicates that
illnesses traceable to shellfish from multiple sources within a particular
state or country have occurred, or
4. There is other evidence that shellfish
from that state or country may pose a danger to public health and that other
regulatory initiatives have failed to control the problem, the Commissioner may
notify the appropriate shellfish control agency that all shellfish originating
from or handled in that state or country shall be prohibited from being sold in
Massachusetts.
(b)
Prohibitions on the sale of shellfish under 105 CMR 500.021(F)(3)(a) shall
continue until the appropriate shellfish control agency in the state or country
satisfactorily certifies to the Commissioner that the shellfish distributed in
Massachusetts will meet the sanitary standard in 105 CMR 500.021(F)(1). Until
such certification has been reviewed and accepted by the Commissioner upon the
recommendation of the Program, no shellfish originating from any person in a
state or country notified pursuant to 105 CMR 500.021(F)(3)(a) shall be sold in
Massachusetts.
(G) Certification for Interstate Shipment.
(1) In certifying
wholesale dealers for listing on the Interstate Certified Shellfish Shippers
List (ICSSL), the Department shall follow the procedures in administrative
guidelines of the Department based on the NSSP Model Ordinance.
(2) Only those wholesale dealers who
voluntarily request certification, and who meet the standards specified in the
Department's administrative guidelines based on the NSSP Model Ordinance for
listing on the ICSSL, and who are certified for listing by the Department,
shall be allowed to ship shellfish or shellfish products interstate or to
another certified dealer within the Commonwealth.
(3) The Department shall annually certify
wholesale dealers for listing on the ICSSL. All certifications shall expire at
the end of each calendar year.
(4)
The Department shall certify for listing on the ICSSL for the following
calendar year only those wholesale dealers who meet the requirements specified
in the Department's administrative guidelines based on the NSSP Model
Ordinance.
(5) Inspection reports
and Notices of Violation/Orders to Correct shall constitute prima
facie evidence of the conditions listed therein.
(6) Wholesale dealers who are removed, either
voluntarily or involuntarily, from the ICSSL shall promptly notify their
customers and the Department in writing that they are no longer involved in the
interstate shipment of shellfish.
(7)
Immediate Suspension of an
ICSSL Certification without a Prior Hearing. The Department may,
without a prior hearing, suspend the ICSSL certification of a certified dealer
for any violation or series of violations of the standards established in the
Department's administrative guidelines based on the NSSP Model Ordinance,
including but not limited to:
(a) A
deficiency or activity that presents an imminent danger to the public
health;
(b) Failure to immediately
correct a critical deficiency;
(c)
Failure to submit an approved correction plan in a timely manner;
(d) Failure to comply with an approved
correction plan for a key or critical deficiency in a timely manner;
(e) Citation for improper tagging;
or
(f) Citation for operation
without a proper endorsement.
The Department may end the suspension of the certification at any time if reasons for the suspension no longer exist. In such a case, the Department shall notify the federal program to include the dealer's name in the next available publication.
(8)
Refusal to Issue an ICSSL
Certification. The Department may refuse to issue an ICSSL
certification if the applicant fails to meet the standards for initial
certification established in the Department's administrative guidelines based
on the NSSP Model Ordinance. These standards include but are not limited to the
facts that the applicant must have:
(a) No
critical deficiencies;
(b) Not more
than two key deficiencies; and
(c)
Not more than three other deficiencies.
The initial certification shall include a compliance schedule to correct the deficiencies, if necessary.
(9)
Refusal to Renew an ICSSL
Certification. The Department may refuse to renew an ICSSL
certification if the applicant fails to comply with the standards for
certification renewal established in the Department's administrative guidelines
based on the NSSP Model Ordinance. These standards include but are not limited
to requiring that the applicant:
(a) Eliminate
any critical deficiencies;
(b)
Agree to a compliance schedule which carries forward into the next
certification period no more than one key and two other deficiencies identified
in previous inspection;
(c) Address
any new key or other deficiencies in a new or revised compliance schedule;
and
(d) Meet the requirements of
certification described in the Department's administrative guidelines based on
the NSSP Model Ordinance.
Following the refusal to renew the certification, a dealer must meet the requirements of initial certification prior to restoration to the ICSSL.
(10) The
Department may refuse to issue or renew an ICSSL certification if the applicant
fails to submit an approved correction plan in a timely manner.
(11) The suspension of a permit or of a
specific activity of a wholesale shellfish dealer shall automatically result in
the immediate suspension of such dealer's ICSSL certification, or certification
for the specific activity that was suspended.
(12) The Department may suspend those
activities related to shellfish on the dealer's permit whenever the dealer's
ICSSL certification is suspended, revoked, or not renewed.
Disclaimer: These regulations may not be the most recent version. Massachusetts may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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