FDA Home Page |
CFSAN Home | Search/Subject Index | Q & A | Help
National Shellfish Sanitation Program
Guide for the Control of Molluscan Shellfish
2003
Model Ordinance
I. Shellfish Sanitation Program
Table of Contents
Requirements for the Authority.
Additional Guidance - IV Guidance Documents
[Note: The Authority must meet the requirements of this section even if the
Authority does not formally adopt this section in regulation.]
@.01 Administration.
- Scope. The Authority shall establish a statewide shellfish safety and
sanitation program to regulate:
(1) The classification of shellfish growing areas;
(2) The harvesting of shellfish;
(3) Shellfish processing procedures and facilities;
(4) Product labeling;
(5) Storage, handling and packing;
(6) Shellfish shipment in interstate commerce;
(7) Shellfish dealers; and
(8) Bivalve aquaculture.
- Records. The Authority shall maintain records to demonstrate the effective
administration of a statewide shellfish safety and sanitation program.
These records shall be maintained in a central file and made available
to any interested person upon request, consistent with appropriate state
and federal law.
- Shared Responsibilities. If more than one agency is involved in the
administration of the statewide shellfish safety and sanitation program,
memoranda of agreement shall be developed between the agencies to define
each agency's responsibilities.
- Administrative Procedures. The Authority shall have administrative procedures
sufficient to:
(1) Regulate shellfish harvesting, sale, or shipment; and
(2) Ensure that all shellfish shipped in interstate commerce originate
from a dealer located within the state from which the shellstock are harvested
or landed, unless the Authority has a memorandum of understanding with the Authority
in another State to allow dealers from its state to purchase the shellstock.
(3) Detain, condemn, seize, and embargo shellfish.
(4) Assure compliance with Shellfish Plant Inspection Standardization.
- Epidemiologically Implicated Outbreaks of Shellfish-Related Illness.
The Authority shall have procedures for investigating incidents of shellfish
borne disease.
- Commingling.
(1) Except for any shellstock included in the Authority's commingling
plan, the Authority shall not permit the commingling of shellstock.
(2) If the Authority permits shellstock commingling, the Authority
shall develop a commingling management plan. The plan shall:
- (a) Minimize the commingling dates of harvest and growing
areas;
(b) Define a primary dealer;
(c) Limit the practice of commingling to primary dealers;
(d) Limit commingling to shellstock harvested from specific
growing areas within the State as identified by the Authority
and purchased directly from harvesters; and
(e) Define how the commingled shellstock will be identified.
Additional Guidance - IV Guidance Documents
@.02 Dealer Certification.
- General
(1) A person requesting certification shall be subject to a comprehensive,
onsite inspection and meet the criteria in §B. or §C.,
as appropriate. The plant inspection shall be conducted by the state
shellfish standardization inspector, using
the appropriate inspection form, within the 120-day period immediately
prior to the issuance or renewal
of the certification.
(2) Certification shall be given only to persons who meet the established
requirements established for certification.
(3) All certifications shall expire annually. The month selected for
certification expiration shall be at the discretion of the Authority.
(4) The Authority shall issue only one certification number to a dealer
for a location. A person or dealer may obtain more than one certification
if each business is:
- (a) Maintained as a separate entity; and
(b) Is not found at the same location.
(5) The Authority may permit separate certified dealers to share a facility.
(6) The certification number issued to each dealer by the Authority
shall be unique.
(7) Adequate records documenting each dealer's compliance with certification
requirements shall be maintained for at least three years.
These records shall include:
- (a) Inspection reports of dealers;
(b) Notification letters and enforcement actions;
(c) Shellfish sample results and follow-up actions taken;
(d) Records of complaints or inquiries and follow-up actions
taken; and
(e) Administrative hearing transcripts and records.
-
- Initial Certification.
(1) Initial certification shall be given only to persons who meet the
following requirements:
- (a) HACCP requirements:
- (i) A HACCP plan accepted by the Authority;
(ii) No critical deficiencies;
(iii) Not more than 2 key deficiencies;
(iv) Not more than 2 other deficiencies.
- (b) Sanitation and additional Model Ordinance Requirements
- (i) No critical deficiencies;
(ii) Not more than 2 key deficiencies;
(iii) Not more than 3 other deficiencies.
(2) The initial certification shall include a compliance schedule
to correct any deficiencies not corrected by the dealer during the inspection.
- Renewal of Certification.
(1) A dealer shall make application for certification renewal annually
at the time specified by the Authority. The Authority shall not renew the certification
for any dealer until the dealer:
- (a) Meets the requirements of §B.1(a) and §B.1(b).
The number of deficiencies allowed under §B.1(a) and §B.1(b)
shall include carry over deficiencies from an existing compliance schedule approved by
the Authority and new deficiencies identified during the certification
renewal inspection;
and
(b) Agrees to a compliance schedule to address any new deficiencies
not corrected by the dealer during the inspection.
-
- Revocation or Suspension of Certification.
(1) The Authority shall not allow any dealer whose certification
has been suspended or revoked under §H. to deal in shellfish.
(2) The Authority shall not issue certification to a dealer whose
certification has been suspended or revoked to deal in shellfish until the dealer
meets the requirements for initial certification.
- Interstate Certified Shellfish Shippers List (ICSSL).
(1) When the Authority certifies a person to become a dealer, the Authority
shall notify the FDA for the purpose of having the dealer
listed in the ICSSL. The notice shall be in the format of FDA Form 3038.
(2) The Authority shall notify the FDA for the purpose of having the
dealer removed from the ICSSL whenever a dealer's certificate
is:
- (a) Suspended; or
(b) Revoked.
-
- Inspections.
(1) After any person is certified, the Authority shall make unannounced
inspections of the dealer's facilities:
- (a) During periods of activity; and
(b) At the following minimum frequencies:
- (i) Within 30 days of beginning activities if the dealer
was certified on the basis of a pre-operational inspection;
(ii) At least monthly for dealer facilities certified as depuration
processors;
(iii) At least quarterly for dealer's activities certified
as shucker-packer or repacker; and
(iv) At least semiannually for other dealer activities
(2) The Authority shall provide a copy of the completed inspection
form to the person in-charge at the dealer's operation at the time of inspection.
The inspection form shall contain a listing of deficiencies by area
in the operation and inspection item
with corresponding citations to this Model Ordinance.
- Performance Based Inspection Program (PIP).
(1) A performance based inspection program may be instituted by the
Authority for any dealer who meets the requirements of this section.
(2) The minimum frequency of inspection under a PIP shall be no less
than one inspection per certification period. The recertification inspection may
qualify as the required minimum inspection frequency.
(3) To be eligible for a PIP, the dealer shall have demonstrated a history
of satisfactory compliance for the previous three-year period. The
three-year demonstration shall include:
- (a) Full compliance with the minimum inspection frequency
shown under §F.;
(b) Recertification of the dealer by the Authority;
(c) Verification that no critical deficiencies, no more than
one key deficiency and no more than two other deficiencies have
occurred in any one inspection;
(d) Correction of all identified deficiencies in accordance
with the compliance schedule approved by the Authority; and
(e) No repetition of the identified deficiencies.
-
- Enforcement.
(1) General.
- (a) The Authority shall use any combination of administrative
hearings, fines, certification cancellations, temporary
suspension of operating licenses, embargoes, product condemnations or product seizures to accomplish
the implementation of this Ordinance.
(b) When a dealer has failed to meet the compliance schedule,
the Authority shall:
- (i) Consider whether it is appropriate to revise the compliance
schedule, suspend or revoke the dealer's certification,
or seek other administrative remedies; and
(ii) Document why an option was selected.
(2) Actions Triggered by Inspections.
- (a) When any inspection detects a critical deficiency:
(i)
The deficiency shall be corrected during that inspection; or
(ii)
The dealer must cease production affected by the deficiency.
- (b) When the dealer fails to comply with (a) above, the Authority
shall immediately begin actions to suspend or revoke the dealer's
certification.
(c) Product affected by a critical deficiency shall be controlled
to prevent contaminated or adulterated product from
reaching consumers. When necessary the Authority shall:
- (i) Detain or seize any undistributed lots of shellfish
that may have been adulterated;
(ii) Initiate a recall of any distributed shellfish; and
(iii) Immediately notify the enforcement officials for FDA
and any other Authorities where the product was distributed.
- (d) When any inspection detects any key or other deficiencies
not already covered in a compliance schedule, the Authority,
working with the dealer, shall develop a compliance schedule
to correct the new key or other deficiencies.
(e) When any inspection detects four or more new key deficiencies,
the Authority shall consider the following options and document
the reasons for the selection of a particular option:
- (i) Revise the existing compliance schedule;
(ii) Suspend or revoke the dealer's certification; or
(iv) Seek other administrative remedies.
-