Current through Register 1531, September 27, 2024
All licensees and permit holders shall comply with the
following requirements.
(A)
Person in Charge. There shall be a person in charge
present in the facility during all hours of operation. The person in charge
shall be responsible for the facility's compliance with all relevant
requirements of
105 CMR 500.000.
(B)
Source of Food;
Ingredients.
(1) All food shall
be obtained from approved sources that comply with law.
(2) Food and ingredients for use in any food
product shall not bear or contain any pesticide chemical or other residues in
excess of levels permitted pursuant to state or federal law.
(C)
Non-food Uses:
Prohibition. No food or food ingredient, including water intended
for bottling, shall be stored, transported, processed, or bottled through
equipment or lines used for any non-food product.
(D)
Source of Water and
Ice. All water and ice used in the manufacture of food products,
whether used in facility or equipment operations or as an ingredient in any
product, shall be from an approved source of water as follows:
(1) Water from a Massachusetts public water
supply source shall meet the quality standards of
310 CMR
22.00: Drinking Water, promulgated by
the Massachusetts Department of Environmental Protection (DEP), and of any
additional maximum contaminant levels promulgated by the U.S. Environmental
Protection Agency (EPA) and in effect.
(2) Water from a private source of water in
Massachusetts, if used:
(a) As an ingredient
in any product, shall meet the standard in 105 CMR 500.005(D)(1), and
(b) Solely in facility or equipment
operations, shall meet standards established by the Department.
(3) Water from a source outside
Massachusetts shall meet the quality standards of 40 CFR Parts 141 and 143:
National Primary and Secondary Drinking Water Regulations,
promulgated by the EPA, and any additional maximum contaminant levels
promulgated by EPA and in effect.
(4) Sea water may be used to deliver, chill,
or hold live or unprocessed seafood, except as otherwise determined by the
Department.
(E)
Major Food Allergens. Whenever a facility uses the
same equipment for processing multiple products and makes a transition from
processing a product containing a major food allergen to a product containing
no major food allergen or a different major food allergen, it shall:
(1) Ensure that all of the product-contact
surfaces of the equipment are fully washed and rinsed in a manner sufficient to
clear the equipment of any residual allergen before the second product is
processed, or
(2) Process products
containing a particular major food allergen on dedicated processing
equipment.
(F)
Ready-to-eat Foods. Food handlers shall not contact
exposed, ready-to-eat food with their bare hands but shall use suitable
utensils such as deli tissue, spatulas, tongs, single-use non-latex gloves, or
dispensing equipment.
(G)
Cooling of Potentially Hazardous Foods.
(1) Food manufacturing shall be conducted
under such conditions and controls as are necessary to minimize the potential
for the growth of microorganisms and for the contamination of food. The
licensee or permit holder shall use processes that are adequate to prevent
adulteration of food and growth of harmful microorganisms.
(2) Specific processes outlined in the
Sanitation Standard Operating Procedure, as required by 105 CMR 500.005(H)(4),
shall be validated by means of laboratory testing or monitoring of specific
control factors such as pH, water activity, temperature, time/temperature,
acidification, flow rate, and similar factors.
(H)
Sanitation Standard Operating
Procedure (SSOP). Each licensee and permit holder shall develop
and implement a Sanitation Standard Operating Procedure (SSOP). The SSOP shall
be modified as necessary and shall adequately address the following areas:
(1) Safety of the operations water in the
facility;
(2) Construction,
condition, maintenance of, and cleaning procedures for the facility, holding
tanks, piping and all related equipment, utensils, washing equipment, and food
transportation vehicles under the control of the licensee or permit
holder;
(3) Prevention of
cross-contamination;
(4)
Manufacturing processes, including thermal processing and product
cooling;
(5) When a major food
allergen is an ingredient of any product, procedures for the use of all
equipment that comes in contact with the allergen, including procedures for
cleaning and flushing/rinsing the equipment in a manner sufficient to clear the
equipment of any residual allergen;
(6) Production records for each production
run, including information on cleaning and sanitizing the equipment;
(7) Maintenance of hand washing, hand
sanitizing, and toilet facilities;
(8) Protection of packaging and product
contact surfaces from contamination;
(9) Proper labeling, storage, and handling of
all toxic substances in the facility;
(10) Sanitization procedures;
(11) Employee health and hygiene;
(12) Employee training;
(13) Exclusion of pests;
(14) Food transportation defense as provided
in
105 CMR
500.007(D); and
(15) Procedures for daily monitoring and
recording compliance with the SSOP.
(I)
Records. At all
times, the facility shall maintain, and make available to inspectors, records
sufficient to conduct trace-back and trace-forward of food products in the
distribution system.
(J)
Emergency Action Plan.
(1) Each facility shall develop, maintain on
file, and follow a written emergency action plan. Appropriate personnel shall
be trained in the implementation of the plan. The plan shall contain, but need
not be limited to:
(a) Contact information
for, and procedures for notification of, local emergency services, the board of
health, the Department, and FDA or USDA as appropriate;
(b) Procedures to be followed in the case of
foreseeable emergency events, including but not limited to loss of water or
power, flood, fire, and intentional or accidental contamination of
food;
(c) Procedures to implement a
product recall; and
(d) Names and
contact information for the primary suppliers of ingredients to the facility
(to enable trace-back) and for the facility's primary customers (to enable
trace-forward).
(2) A
licensee or permit holder shall notify the Department immediately when an
imminent danger to the public health is present in the facility or its
products.
(3) Any licensee or
permit holder may present for advance review and approval by the regulatory
agency a plan to continue operations during an emergency and/or to respond to
an emergency due to natural or man-made causes.
(K)
Product Recall.
(1) A facility operator who knows or has
reason to believe that circumstances exist that may adversely affect the safety
of products, including but not limited to major spills, serious accidents,
introduction of toxins or contaminants, natural disasters, or major breakdowns
in production, shall notify the Program immediately.
(2) Each facility operator shall develop and
maintain on file a current written contingency plan for use in initiating and
accomplishing a product trace and recall, and shall follow the plan as
appropriate. The plan shall include procedures for the notification of the
Program, consumer notification, and recall of the product.
(a) Recalls of meat or poultry products shall
conform to the procedures and policies established by USDA.
(b) Recalls of products other than meat or
poultry products shall conform to the procedures and policies of 21 CFR Part 7
: Enforcement Policy.
(3) The facility shall use sufficient coding
of products to make possible positive lot identification and to facilitate
effective recall of all violative lots. The code shall be designed to remain
affixed to the container during retail distribution and consumer use.
(4) The facility shall maintain such product
distribution records as are necessary to enable location of products if a
recall is initiated. These records shall be maintained for two years after
December 31st of the year in which the product was
processed.
(5) The facility shall
implement the recall procedures as necessary with respect to any product which
the facility or the Department knows or has reason to believe may adversely
affect its safety for the consumer.
(6) If the Department determines that the
circumstances present an imminent danger to the public health and that a form
of consumer notice and/or product recall can effectively avoid or significantly
minimize the threat to public health, the Department may advise the facility:
(a) To initiate a level of product recall
approved by the Department, and/or
(b) If appropriate, to issue a form of
notification to consumers.
1. The facility
shall be responsible for disseminating the notice in a manner designed to
inform consumers who may be affected.
2. The facility shall, where appropriate,
provide the notice to the news media serving the affected public, and/or shall
directly notify affected consumers when doing so effectively avoids or
minimizes the risk to health.
(L)
Maintenance of
Records. All records required to be kept by
105 CMR 500.000 shall be
maintained on file for at least two years, or for the time required by another
specific record-keeping requirement in
105 CMR 500.000, and shall
be made available to agents of the regulatory agency for inspection and copying
upon request.
1 The requirements in 105 CMR
500.005 apply to all facilities that are not subject to USDA inspection, and
are recommended for all facilities that are subject to USDA
inspection
