A.
|
General. Each growing area shall
be correctly
classified as approved, conditionally approved, restricted,
conditionally restricted, or prohibited, as provided by this Ordinance.
(1)
|
Emergency Conditions. A
growing area
shall be placed in the closed status under §.03A(5) when pollution
conditions exist which were not included in the database used to
classify the area. If it is determined that an emergency condition or situation exists, than the growing area will be immediately (within 24 hours) placed in the closed status. |
| (2) |
Classification of All
Growing Areas. All growing areas which:
| (a) |
Are not subjected to
a sanitary survey every twelve years
shall be classified as prohibited; |
| (b) |
Have
a sewage treatment plant outfall or other point source outfall of
public health significance within or adjacent to the growing area shall
have an area in the prohibited classification established adjacent to
the outfall in accordance with §E. Prohibited Classification; and |
| (c) |
Are
subjected to a sanitary survey shall be correctly classified based on
the twelve year sanitary survey, and its most recent triennial or
annual reevaluation when available, as only one of the following:
| (i)
|
Approved; |
| (ii) |
Conditionally
Approved; |
| (iii) |
Restricted; |
| (iv) |
Conditionally
Restricted; or |
| (v) |
Prohibited. |
|
|
(3)
|
Boundaries. The boundaries
of each classified growing area
shall be delineated on charts which are:
| (a) |
Of sufficient scale
and detail so as to adequately
describe the boundaries; and |
| (b) |
Maintained in the
central file by the Authority. |
|
(4)
|
Revision of
Classifications.
| (a) |
Any upward revision
of a growing area classification
shall be supported by an adequate sanitary survey. |
| (b) |
The appropriate FDA
regional office shall be notified of
any revision in growing area classification. |
|
(5)
|
Status
of Growing Areas. The status of a growing area is separate and distinct
from its classification and may be open, closed or inactive for the
harvesting of shellstock.
| (a) |
Open Status. Except
for an area in the
prohibited classification, any correctly classified growing area, is
normally open for the purposes of harvesting shellstock, subject to the
limitations of its classification.
|
| (b) |
Closed Status. Any
classified growing area may be closed
for a limited or temporary period because of:
(i)
|
An emergency
condition or situation; |
| (ii) |
The presence
of biotoxins in concentrations of public
health significance; or |
| (iii) |
Conditions
stipulated in the management plan of
conditionally approved or conditionally restricted areas; or |
| (iv) |
Failure of the
Authority to complete a written
sanitary survey or triennial review evaluation report. |
|
| (c) |
Reopened
Status. A growing area temporarily placed in the closed status as
provided in (b) above, shall be returned to the open status only when:
(i)
|
The emergency
situation or condition
has returned to normal and sufficient time has elapsed to allow the
shellstock to reduce pathogens or poisonous or deleterious substances
that may be present in the shellstock to acceptable levels. Studies
establishing sufficient elapsed time shall document the interval
necessary for reduction of contaminant levels in the shellstock to
pre-closure levels. In addressing pathogen concerns, the study may
establish criteria for reopening based on coliform levels in the
water; or |
| (ii) |
The
requirements for biotoxins or conditional area
management plans as established in §.04 and §.03,
respectively, are met; and |
| (iii) |
Supporting
information is documented by a written
record in the central file. |
|
| (d) |
Inactive
Status. The authority may place an approved or restricted growing area
affected by non-point sources in the inactive status for up to five
years when shellstock harvest is suspended or no longer occurring.
Shellstock harvesting shall be closed while an area is in the inactive
status. The inactive status must continue for a minimum of one year.
| (i)
|
While in
inactive status, the required
bacteriological sample collection under @.02F (6)(b)(iii) may be
reduced to two water samples per station per year collected under the
systematic random sample collection strategy. Sanitary survey reports,
triennial reevaluations, and annual updates must be completed as
required under @.01C. |
| (ii) |
The sample
collection frequency of
six random samples per station per year specified under @.02F
(6)(b)(iii) must resume at least six months before an area is
reactivated. |
| (iii) |
Before an area
is reactivated, the results of
the most recent 30 samples must be reviewed and comply with the
requirements under @. 02F. |
|
| (e) |
Remote Status. A
growing area may be placed in the remote
status if:
| (i)
|
A
sanitary survey determines that the area has no human habitation, and
is not impacted by any actual or potential pollution sources; and |
| (ii) |
The area is in
the approved classification. |
|
| (f) |
Seasonally
Remote/Approved Status. A growing area may be placed in a seasonally
remote/approved status requiring two water samples per year if the
following criteria are met:
| (i)
|
The area is
initially classified as approved; |
| (ii) |
The closure
time period is defined; and |
| (iii) |
At least one
sample be taken upon reopening the area. |
|
|
|
B.
|
Approved Classification. Growing
areas shall be classified as
approved when the following criteria are met.
(1)
|
Survey Required. A
sanitary survey finds that the area is:
| (a) |
Safe for the direct
marketing of shellfish; |
| (b) |
Not
subject to contamination from human or animal fecal matter at levels
that, in the judgement of the Authority, presents an actual or
potential public health hazard; and |
| (c) |
Not contaminated
with:
| (i)
|
Pathogenic
organisms; |
| (ii) |
Poisonous or
deleterious substances; |
| (iii) |
Marine
biotoxins; or |
| (iv) |
Bacteria
concentrations exceeding the bacteriological
standards for a growing area in this classification. |
|
|
| (2) |
Water
Quality. The water quality in the growing area shall meet the
bacteriological standards for an approved classification in §.02. |
|
C.
|
Conditional Classifications.
Growing areas may be classified as
conditional when the following criteria are met:
(1)
|
Survey Required. The
sanitary survey meets the following
criteria:
| (a) |
The
area will be in the open status of the conditional classification for a
reasonable period of time. The factors determining this period are
known, are predictable, and are not so complex as to preclude a
reasonable management approach; |
| (b) |
Each potential
source of pollution that may adversely
affect the growing area is evaluated; |
| (c) |
Bacteriological
water quality correlates with environmental conditions or other factors
affecting the distribution of pollutants into the growing area. |
|
| (2) |
Management Plan Required.
For each growing area, a written
management plan shall be developed and shall include:
| (a) |
For management plans
based on wastewater treatment plant
function, performance standards that include:
| (i)
|
Peak effluent
flow, average flow, and infiltration
flow; |
| (ii) |
Bacteriological
quality of the effluent; |
| (iii) |
Physical and
chemical quality of the effluent; |
| (iv) |
Conditions
which cause plant failure; |
| (v) |
Plant or
collection system bypasses; |
| (vi) |
Design,
construction, and maintenance to minimize
mechanical failure, or overloading; |
| (vii) |
Provisions for
monitoring and inspecting the waste
water treatment plant; and |
| (viii) |
Establishment
of an area in the prohibited classification adjacent to a wastewater
treatment plant outfall in accordance with §E. Prohibited
Classification; |
|
| (b) |
For management plans
based on pollution sources other
than waste water treatment plants:
| (i)
|
Performance
standards that reliably predict when
criteria for conditional classification are met; and |
| (ii) |
Discussion and
data supporting the performance
standards. |
|
| (c) |
For
management plans based on wastewater treatment plant function or
pollution sources other than wastewater treatment plants, criteria that
reliably predict when an area that was placed in the closed status
because of failure to comply with its conditional management plan can
be returned to the open status. The minimum criteria are:
| (i)
|
Performance
standards of the plan are fully met; |
| (ii) |
Sufficient
time has elapsed to allow the water
quality in the growing area to return to acceptable levels; |
| (iii) |
Sufficient
time has elapsed to allow the shellstock to reduce pathogens that might
be present to acceptable levels. Studies establishing sufficient
elapsed time shall document the interval necessary for reduction of
coliform levels in the shellstock to pre-closure levels. The study may
establish criteria for reopening based on coliform levels in the water;
and |
| (iv) |
Shellstock
feeding activity is sufficient to achieve
coliform reduction. |
|
| (d) |
For
management plans based on a risk assessment made in accordance with
Chapter II, Risk Assessment and Risk Management, criteria that reliably
determine when the growing area may be placed in the open status and
shellfish may be harvested; |
| (e) |
For management
systems based on
marine biotoxins, the procedures and criteria that reliably determine
when the growing area may be placed in the open status; |
| (f) |
Procedures for
immediate notification to the Authority
when performance standards or criteria are not met; |
| (g) |
Provisions for
patrol to prevent illegal harvest; and |
| (h) |
Procedures
to immediately place the growing area in the closed status in 24 hours
or less when the criteria established in the management plan are not
met. |
|
(3)
|
Reevaluation of
Conditional Classification.
| (a) |
The classification
shall be reevaluated at least once
each year. The reevaluation shall include:
| (i)
|
Evaluation of
compliance with the management plan; |
| (ii) |
Determination
of adequacy of reporting of failure to
meet performance standards; |
| (iii) |
Review of the
cooperation of the persons involved; |
| (iv) |
Evaluation of
water quality in the growing area with
respect to the bacteriological standards for its classification; |
| (v) |
Field
inspection of critical pollution sources, where
necessary; and |
| (vi) |
Written
findings, evaluations and recommendations. |
|
| (b) |
Water Sample
Collection.
| (i)
|
When
the conditional management plan is based on the absence of pollution
from marinas for certain times of the year, monthly water samples are
not required when the growing area is in the open status of its
conditional classification provided that at least three of the water
samples collected to satisfy the bacteriological standard for the open
status are collected when the growing area is in the open status. |
| (ii) |
When
the conditional management plan is based on the operation and
performance of a wastewater treatment plant(s); combined sewer
overflow(s); or other point sources of pollution, monthly water samples
are required when the growing area is in the open status of its
conditional classification. |
| (iii) |
If a monthly
sample cannot
be collected due to environmental constraints, the monthly sampling
requirement will be satisfied if an additional water sampling run is
conducted the following month. |
| (iv) |
When the
conditional
management plan is based on the effects of non-point sources of
pollution, such as rainfall events, stormwater runoff, and seasonal
variations, a minimum of five (5) sets of water samples (when the
Adverse Pollution Condition sampling regimen is used) or six (6) sets
of water samples (when the Systematic Random Sampling regimen is used)
are required. The samples shall be collected when the growing area is
in the open status. |
| (v) | When the conditional management plan is based on the effects of non-point sources of pollution, such as rainfall events or storm water runoff, and the area is in the open status for less than six months a minimum of five (5) sets of water samples are required (Adverse Pollution Condition and Systematic Random Sampling). At least one (1) sample shall be collected each month the area is placed in the open status. This sample shall be collected while the area is open. If closed status samples are used to meet the minimum sample requirements only two (2) sets of samples may be utilized and they must have been taken within five (5) days of when the Authority anticipates that the area will be placed in the open status. For growing areas in the open status less than two (2) months, at least one (1) sample must be collected while the area is in the open status. Samples collected during the closed status to meet the minimum five (5) sets of water samples shall be applied to annual and triennial reevaluations of the area. |
| (vi) | When the conditional management plan is based on the seasonal opening and closing of the area, and the area is in the open status for a predetermined period of less than six (6) months, a minimum of five (5) sets of water samples are required (Adverse Pollution Condition and Systematic Random Sampling). All samples shall be collected while the area is in the open status unless the Authority has historical water quality data to demonstrate that the area meets open status criteria while in the closed status. If closed status samples are used to meet the minimum sample requirements they must be collected within thirty (30) days prior to the area being placed in the open status. |
|
|
| (4) |
Understanding
of and Agreement With the Purpose of the Conditional Classification and
Conditions of Its Management Plan by All Parties Involved.
(a)
|
The management plan
shall be developed by the Authority
in coordination with:
| (i)
|
The local
shellfish industry; |
| (ii) |
The
individuals responsible for the operation of any
wastewater treatment plants involved; and |
| (iii) |
Any local or
State agencies; and |
|
| (b) |
Failure
of any one party to agree shall constitute sufficient justification to
deny the application of the conditional classification to a growing
area. |
|
| (5) |
Conditional Area Types.
There are two types of conditional
areas:
| (a) |
Conditionally
approved; and |
| (b) |
Conditionally
restricted. |
|
| (6) |
Conditionally Approved
Classification. Any growing area in
the conditionally approved classification shall:
| (a) |
Meet the
requirements for:
| (i)
|
An approved
area classification when the
conditionally approved classification is in the open status; and |
| (ii) |
A restricted
or prohibited classification when the
conditionally approved classification is in the closed status; and |
|
| (b) |
If
the closed status meets the criteria for the restricted classification,
designate in its management plan whether the shellstock may be
harvested for relaying or depuration. |
|
| (7) |
Conditionally Restricted
Classification. Any growing area in
the conditionally restricted classification shall:
| (a) |
Meet the
requirements for:
| (i)
|
A restricted
classification when the conditionally
restricted classification is in the open status; and |
| (ii) |
A prohibited
classification when the conditionally
restricted classification is in the closed status; and |
|
| (b) |
Designate in its
management plan whether the harvested
shellstock are to be relayed or depurated. |
|
|
D.
|
Restricted Classification.
(1)
|
General
(a)
|
A growing area may
be classified as restricted when:
(i)
|
A sanitary
survey indicates a limited degree of
pollution; and |
(ii)
|
Levels
of fecal pollution, human pathogens, or poisonous or deleterious
substances are at such levels that shellstock can be made safe for
human consumption by either relaying, depuration or low acid-canned
food processing. |
|
(b)
|
The Authority shall
have effective controls to assure
that shellfish are harvested from restricted areas only:
(i)
|
By special
license; and |
(ii)
|
Under the
supervision of the Authority. |
|
|
(2)
|
Water
Quality. Water quality in the growing area shall meet the
bacteriological standards in §.02 for a growing area in the
restricted
classification if the growing area is used for depuration.
|
(3)
|
Shellstock
Quality Criteria. The Authority shall establish shellstock quality
criteria for use in placing an area in the restricted classification.
Depending on the treatment process to be applied to the shellstock, the
criteria shall be established in accordance with:
(a)
|
Chapter V.
Shellstock Relaying; or |
| (b) |
Chapter XV. Depuration. |
|
|
E.
|
Prohibited Classification.
(1)
|
Exception.
The prohibited classification is not required for harvest waters within
or adjacent to marinas. The Authority, however, may use the prohibited
classification for these waters. |
| (2) |
General. The Authority shall:
| (a) |
Not permit the
harvest of shellstock from any area
classified as prohibited, except for the
harvest of shellstock for the gathering of seed for aquaculture or the
depletion of the areas classified as prohibited; and |
| (b) |
Ensure that
shellstock removed from any growing area
classified as prohibited is effectively excluded from human
consumption unless it is seed to be cultured as outlined in NSSP MO Chapter VI. Shellfish Aquaculture.02 Seed Shellstock. |
|
| (3) |
Sanitary Survey. A growing
area shall be classified as
prohibited if:
| (a) |
No current sanitary
survey exists; |
| (b) |
A sanitary survey
determines:
| (i)
|
The growing
area is adjacent to a sewage treatment
plant outfall or other point source outfall with public health
significance; |
| (ii) |
Pollution
sources may unpredictably contaminate the
growing area; |
| (iii) |
The growing
area is contaminated with fecal waste so
that the shellfish may be vectors for disease microorganisms; |
| (iv) |
The
concentration of biotoxin is sufficient to cause
a public health risk as identified in §.04. or |
| (v) |
The area is
contaminated with poisonous or
deleterious substances causing the shellfish to be adulterated. |
|
|
| (4) |
Risk
Assessment. A growing area shall be classified as prohibited if a risk
assessment performed in accordance with Chapter II, Risk Assessment and
Risk Management indicates the shellstock are not safe for human
consumption.
|
| (5) |
Wastewater Discharges.
| (a) |
An
area classified as prohibited shall be established adjacent to each
sewage treatment plant outfall or any other point source outfall of
public health significance. |
| (b) |
The determination of
the size
of the area to be classified as prohibited adjacent to each outfall
shall include the following minimum criteria:
| (i)
|
The volume
flow rate, location of
discharge, performance of the wastewater treatment plant and the
bacteriological quality of the effluent; |
| (ii) |
The decay rate
of the contaminants of public health
significance in the wastewater discharged; |
| (iii) |
The
wastewater's dispersion and dilution, and the
time of waste transport to the area where shellstock may be harvested;
and |
| (iv) |
The location
of the shellfish resources,
classification of adjacent waters and identifiable landmarks or
boundaries. |
|
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