Current through Register Vol. 46, No. 12, March 20, 2024
(a)
General permits. Every person who operates a transfer station, receiving
station, bulk tank unit or milk plant (other than a plant at which melloream or
frozen desserts are manufactured) in the State shall hold a general permit
issued by the commissioner. A general permit holder, a person holding a frozen
desserts license pursuant to Agriculture and Markets Law section 71-d ("frozen
desserts licensee") and a person holding a melloream license pursuant to
Agriculture and Markets Law section 50-g ("melloream licensee") shall:
(1) if in control of the assembly of the milk
shall:
(i) assign to each dairy farmer who
produces milk assembled by the permit holder an identification
number;
(ii) employ a certified
milk inspector and ensure that he properly carries out his duties;
(iii) arrange to have the required samples of
prepasteurized milk taken from dairy farms from which such prepasteurized milk
is received, in accordance with section
2.6
of this Part, tested and analyzed by a licensed technician at an officially
designated laboratory to determine compliance with the standards set forth in
section
2.8 of this
Part. The permit holder, frozen desserts licensee and melloream licensee shall,
if requested, accurately inform the commissioner when samples will be taken
from any dairy farm from which prepasteurized milk is received prior to having
such samples taken;
(iv) arrange to
have the required inspections done of dairy farms from which prepasteurized
milk is received, in accord with section
2.5 of this
Part;
(v) receive no prepasteurized
milk from a new source unless the commissioner has been notified at least four
days in advance and such source has been inspected by an employee of the
Division of Milk Control and found to be in compliance with sections
2.9
through
2.28,
2.58 and
2.65 of this
Part; and
(vi) receive no
commingled milk from a permit holder who controls the assembly of the milk from
whom milk is not received on a regular basis, unless a sample thereof has been
properly submitted to a licensed technician for analysis at an officially
designated laboratory and determined to be in compliance with the applicable
standards set forth in section
2.8 of this
Part;
(2) receive or
handle no prepasteurized milk from a dairy farm:
(i) which has not been properly inspected as
required in section
2.5 of this
Part;
(ii) which is not in
substantial compliance with sections
2.9
through
2.28
and sections
2.58 and
2.65 of this
Part;
(iii) whenever the
prepasteurized milk exceeds the temperature standard or fails to meet the
abnormal milk standard set forth in section
2.8 of this
Part, or whenever the milk is otherwise adulterated within the meaning of this
Title or of the Agriculture and Markets Law;
(iv) for the period of time specified in
section
2.7(e)
of this Part, when the prepasteurized milk fails to meet the drug standard set
forth in section
2.8 of this
Part, except that a general permit holder who manufactures a non-Grade A
storable milk product, goat milk product or sheep milk product may receive
prepasteurized milk that does not exceed said drug standard, notwithstanding
the provisions of section
2.7(e)
of this Part, if such prepasteurized milk has been analyzed as provided for in
the provisions of section
2.7(b)(2)
of this Part and found to be in compliance with the applicable provisions of
section
2.8 of this
Part. The general permit holder and the dairy farmer who produced such
prepasteurized milk shall have requested and received approval from the
commissioner prior to the receipt of such prepasteurized milk by such general
permit holder;
(v) whenever three
of the last five samples of prepasteurized milk exceed the bacterial limit set
forth in section
2.8 of this
Part; and
(vi) whenever three of
the last five samples of prepasteurized milk exceed the somatic cells standard
set forth in section
2.8 of this
Part or whenever the dairy farmer is required to enroll in the Quality Milk
Promotion Services Program and has failed to do so;
(3) receive, deal in, sell, offer for sale or
otherwise distribute no prepasteurized milk, commingled milk, milk, lowfat
milk, skim milk, milk product, goat milk, goat milk product, sheep milk, sheep
milk product, melloream or frozen dessert from a person who does not hold a
required permit or license issued pursuant to this Title or the Agriculture and
Markets Law;
(4) receive no
commingled milk that exceeds the drug standard, as provided in section
2.7(b)(1)
of this Part and shall, when commingled milk exceeds the drug standard,
immediately notify the commissioner in writing that the commingled milk has
failed to meet such standard;
(5)
prepare, maintain and make available, for at least two years, unless otherwise
provided, in a form and at a location satisfactory to the commissioner, the
following records and materials:
(i) a record
of bacteriological examinations of the water supply of:
(a) dairy farms, the prepasteurized milk of
which is assembled by the permit holder, frozen dessert licensee or melloream
licensee, in accord with section
2.15 of this
Part; and
(b) the permit holder's,
frozen dessert licensee's or melloream licensee's milk plant, in accord with
section
2.35 of this
Part;
(ii) a record of
the results of required analyses of samples of prepasteurized and commingled
milk for compliance with the standards set forth in section
2.8 of this
Part. The records of results of analyses of samples of prepasteurized milk
shall set forth the:
(a) name and
identification number of the dairy farmer who produced the prepasteurized milk
from which the sample was taken;
(b) date of sampling;
(c) date of analysis;
(d) method used and result of analysis;
and
(e) signature and license
number of the licensed technician who analyzed the sample;
(iii) a record of each inspection and
reinspection of dairy farms conducted pursuant to section
2.5 of this Part.
Each inspection report shall set forth:
(a)
the name and identification number of the dairy farmer;
(b) the date of the inspection or
reinspection;
(c) the signature of
the certified milk inspector who conducted the inspection; and
(d) whether the dairy farm was in substantial
compliance with sections
2.9
through
2.28
and sections
2.58 and
2.65 of this
Part;
(iv) a record of
the name of the owner, identification number and address of all dairy farms
from which prepasteurized milk is assembled by the permit holder, frozen
dessert licensee or melloream licensee;
(v) for analyses made by means of reading
direct microscopic smears, the direct microscopic smears, and retain for at
least 30 days;
(vi) if operating a
milk plant at which frozen desserts are manufactured:
(a) a daily record of receipts and
disposition of all ingredients, other than flavors, cocoa, chocolate, fruits,
nuts, malted milk, confectionery, stabilizers, emulsifiers, microcrystalline
cellulose and sweetening agents, and a monthly inventory of each ingredient for
which a record is kept which reflects the name and address of the person from
whom each ingredient was received;
(b) for each frozen dessert containing fat, a
record setting forth the name of the frozen dessert, the name of the fat and
the percent of fat contained in each frozen dessert;
(c) a daily record of each frozen dessert
manufactured or received, the volume of each frozen dessert manufactured or
received, and the fat content of each frozen dessert manufactured or received;
and
(d) a biannual report setting
forth the amount of each kind of frozen dessert manufactured, the ingredients
used in the manufacture of each frozen dessert, and other information deemed
necessary by the commissioner for the administration of this Part. A report
shall be submitted to the commissioner on or before January 20 and on or before
July 20 of each year, giving the required information for each of the six
calendar months preceding such date;
(vii) such other records or materials
required to be kept pursuant to the provisions of this Part;
(6) if operating a milk plant,
receiving station, or a plant where frozen desserts are manufactured:
(i) handle and process and/or manufacture
milk, lowfat milk, skim milk, milk products, goat milk, goat milk products,
sheep milk, sheep milk products, frozen desserts and melloream in substantial
compliance with sections
2.30
through
2.65 of this
Part and with Appendices 3-11 to this Part; and
(ii) designate a processing plant
superintendent ("PPS") and ensure that he properly carries out his
duties;
(7) receive,
deal in, sell, offer for sale or otherwise distribute no milk, lowfat milk,
skim milk, milk products, goat milk, goat milk products, sheep milk, sheep milk
products, frozen desserts or melloream that do not comply with the applicable
standards and requirements set forth in this Title and in the Agriculture and
Markets Law, or that are in violation of any provision of this Title or of the
Agriculture and Markets Law;
(8)
receive, deal in, sell, offer for sale or otherwise distribute no milk, lowfat
milk, skim milk, non-storable milk products, goat milk, non-storable goat milk
products, sheep milk, non-storable sheep milk products or frozen desserts:
(i) the prepasteurized milk component of
which has not been produced in substantial compliance with the provisions of
this Part applicable to the production of Grade A prepasteurized
milk;
(ii) the prepasteurized milk
component of which does not meet the standards for prepasteurized milk for
Grade A use set forth in section
2.8 of this
Part;
(iii) which has not been
processed or manufactured in compliance with the provisions of this Part
applicable to the processing or manufacture of Grade A milk, lowfat milk, skim
milk, non-storable milk products, goat milk, non-storable goat milk products,
sheep milk, and non-storable sheep milk products; and
(iv) which do not meet the standards for such
foods set forth in section
2.8 of this
Part;
(9) properly carry
out such other responsibilities and duties required of a general permit holder,
frozen dessert licensee or melloream licensee pursuant to the provisions of
this Part.
(b) Permit to
sell raw milk.
(1) Every person who sells,
offers for sale or otherwise makes available raw milk for consumption by
consumers shall hold a permit to sell raw milk issued by the commissioner. A
person who holds a permit to sell raw milk may sell, offer for sale or
otherwise make available raw milk only:
(i)
directly to a consumer;
(ii) on the
dairy farm where such raw milk is produced;
(iii) in a bottle or in a single service
container mechanically filled and capped as set forth in this Part or in a
container provided by the consumer filled in his presence; and
(iv) if at the point of sale a sign is
conspicuously posted, easily capable of being read, from such point, stating:
"NOTICE: Raw milk sold here. Raw milk does not provide the protection of
pasteurization."
(2) A
person who holds a permit to sell raw milk shall:
(i) ensure that the dairy farm at which the
raw milk was produced is in substantial compliance with the provisions of this
Part applicable to the production of Grade A prepasteurized milk;
(ii) sell, offer for sale or make available
no raw milk when and as required in section
2.7(c)
and (d) of this Part;
(iii) sell, offer for sale or make available
no raw milk that exceeds the applicable temperature, drugs or abnormalities
standard set forth in section
2.8 of this
Part;
(iv) sell or offer for sale
no raw milk that is in violation of any provision of this Title or of the
Agriculture and Markets Law; and
(v) enroll in the Quality Milk Promotion
Services when and/or as required by sections
2.7
and
2.60
of this Part.
(c) Permit to ship prepasteurized milk, milk,
lowfat milk, skim milk, non-storable milk products, goat milk and sheep milk
products into the State.
(1) Every person who
ships prepasteurized milk, milk, lowfat milk, skim milk, non-storable milk
products, goat milk or sheep milk into the State shall hold a permit issued by
the commissioner. Such permit shall be known as a "permit to ship milk and milk
products into the State." A permit shall expire on June 30 and an application
for renewal shall be made no later than June 1. An application for renewal
shall be made upon a blank prepared under the direction of the commissioner and
shall set forth the information deemed necessary by the commissioner for the
administration of this Part.
(2) A
person who holds a permit to ship milk or milk products into the State shall:
(i) if shipping prepasteurized milk into the
State:
(a) ensure that the prepasteurized milk
if to be used in Grade A milk, Grade A lowfat milk, Grade A skim milk, Grade A
non-storable milk products, Grade A goat milk or Grade A sheep milk, was
produced on dairy farms in substantial compliance with rules and regulations
substantially the same as the applicable provisions of this Part regulating the
production of Grade A prepasteurized milk and that such prepasteurized milk
complies with and meets the provision of section
2.8 of this
Part for prepasteurized milk for Grade A use;
(b) ensure that the prepasteurized milk if
not to be used in Grade A milk, Grade A lowfat milk, Grade A skim milk, Grade A
non-storable milk products, Grade A goat milk or Grade A sheep milk was
produced on dairy farms in substantial compliance with rules and regulations
substantially the same as the applicable provisions of this Part regulating the
production of non-Grade A prepasteurized milk and that such prepasteurized milk
complies with and meets the provisions of section
2.8 of this
Part for prepasteurized milk for non-Grade A use; and
(c) if shipping prepasteurized milk into the
State for use in Grade A milk, Grade A lowfat milk, Grade A skim milk, Grade A
non-storable milk products, Grade A goat milk or Grade A sheep milk, have an
acceptable milk sanitation compliance and enforcement rating given by a State
milk sanitation rating officer certified by FDA and have an Interstate Milk
Shippers rating of 90 percent or higher;
(ii) if shipping milk, lowfat milk, skim
milk, non-storable milk products, goat milk or sheep milk into the State shall:
(a) ensure:
(1) that the prepasteurized milk in such
foods was produced on dairy farms in substantial compliance with rules and
regulations substantially the same as the provisions of this Part regulating
the production of Grade A prepasteurized milk;
(2) that such foods were processed or
manufactured in substantial compliance with rules and regulations substantially
the same as the provisions of this Part regulating the processing and
manufacture of Grade A milk, lowfat milk, skim milk, non-storable milk
products, goat milk and sheep milk;
(3) that such foods comply with and meet
applicable provisions and standards set forth in the Agriculture and Markets
Law and this Title; and
(4) that
such foods are not in violation of the provisions of the Agriculture and
Markets Law or of this Title nor is their possession, sale or distribution in
violation of such law or of this Part;
(b) ensure that such foods have been
processed or manufactured in a plant that currently possesses:
(1) an acceptable milk sanitation compliance
and enforcement rating given by a state milk sanitation rating officer
certified by the FDA; and
(2) an
Interstate Milk Shippers rating of 90 percent or higher.
(3) A person who holds a permit to ship milk
and milk products into the State shall also ensure that every milk tank truck
containing commingled milk that he ships or causes to be shipped into the State
contains documents available to the commissioner which set forth:
(i) the name and address of the person who
holds the permit;
(ii) the name and
address of the milk hauler; and
(iii) the weight of the commingled
milk.
(d) Permit to produce milk.
Every dairy farmer who produces prepasteurized milk shall
hold a permit to produce milk issued by the commissioner. A dairy farmer who
holds a permit to produce shall:
(1)
if his prepasteurized milk is to be used in milk, lowfat milk, skim milk,
non-storable milk products, goat milk or sheep milk, operate his dairy farm in
substantial compliance with the provisions of this Part applicable to the
production of Grade A prepasteurized milk;
(2) if his prepasteurized milk is to be used
in storable milk products, operate his dairy farm in substantial compliance
with the provisions of this Part applicable to the production of non-Grade A
prepasteurized milk;
(3) produce no
prepasteurized milk that does not comply with the Agriculture and Markets
Law;
(4) enroll in the Quality Milk
Promotion Services Program ("QMPS") when and as required in section
2.6(d)
of this Part;
(5) review the Milk
and Dairy Beef Residue Prevention Protocol, when and as required in section
2.7(e)(2)
of this Part;
(6) deal in, sell,
offer for sale or otherwise distribute no prepasteurized milk when and as
required in section
2.7(c),
(d) and (e) of this Part; and
(7) deal in, sell, offer for sale or
otherwise distribute no prepasteurized milk that exceeds the temperature
standard or fails to meet the abnormal milk standard set forth in section
2.8 of this
Part.
(e) Granting,
denying the renewal of, revoking and suspending permits.
(1) The provisions of this section shall
apply to the granting, denying the renewal of, revoking and suspending permits
required pursuant to this Part, unless otherwise provided in this Part. An
applicant for a general permit, a permit to sell raw milk, a permit to ship
milk and milk products into the State or a permit to produce shall file an
application upon a blank prepared under the direction of the commissioner and
shall set forth the information deemed necessary by the commissioner for the
administration of this Part. Except for a permit to ship milk and milk products
into the State, a permit shall be effective until revoked or suspended. The
commissioner may decline to grant or renew a permit, or may suspend or revoke a
permit, upon due notice and opportunity for a hearing, when he is satisfied by
substantial evidence that the applicant or permit holder:
(i) is not capable of complying with the
requirements of this Part or of the Agriculture and Markets Law; or
(ii) has failed to comply with or has
violated the requirements of this Part or of the Agriculture and Markets
Law.
(2) A permit may be
summarily suspended without a hearing if the commissioner has reason to believe
that raw milk, prepasteurized milk, commingled milk, milk, lowfat milk, skim
milk, milk products, goat milk, goat milk products, sheep milk or sheep milk
products produced, possessed, processed, manufactured, sold, offered for sale
or otherwise distributed by the permit holder create or appear to create, if
consumed, an immediate hazard to human health. After summarily suspending a
permit, the commissioner shall schedule a hearing to consider revocation of the
permit, which hearing shall be held as soon as reasonably possible after the
date the permit was suspended. The summary suspension shall be effective until
the permit holder satisfies the commissioner that no raw milk, prepasteurized
milk, commingled milk, milk, lowfat milk, skim milk, milk product, goat milk,
goat milk product, sheep milk or sheep milk product creates, or appears to
create, an immediate hazard to the public health.