reglab/statecodes huggingface dataset:
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Section 500.002 - Scope

Current through Register 1525, July 5, 2024
(A)
								105 CMR 500.000 applies to
			 every person who prepares, manufactures, packs, repacks, cans, bottles, keeps,
			 exposes, stores, handles, sells, transports, or distributes food in
			 Massachusetts, whether or not for profit. It applies to wholesale food
			 processing operations within food establishments licensed by local boards of
			 health, but does not apply to activities regulated by
			 105 CMR 590.000:
State Sanitary Code, Chapter X - Minimum Sanitation Standards for Food
			 Establishments
.
(B) The
			 requirements of
			 105 CMR 500.000 include but
			 are not limited to every person who:
(1)
			 Operates a residential kitchen to prepare or process food for wholesale
			 sale;
(2) Operates as a retail
			 seafood dealer, a wholesale seafood dealer, or a wholesale seafood
			 truck;
(3) Cooks, smokes, or
			 otherwise processes seafood, or combines seafood with non-seafood
			 ingredient(s), for sale at wholesale;
(4) Engages in the business of slaughtering
			 livestock or poultry or processing meat or poultry for sale at wholesale;
			 engages in the business of custom slaughtering of livestock or poultry; or
			 engages in the business of custom processing of meat or poultry;
(5) Operates a milk pasteurization
			 plant;
(6) Manufactures butter or
			 cheese for sale at wholesale;
(7)
			 Manufactures within Massachusetts frozen desserts or frozen dessert mix, or
			 manufactures frozen desserts or frozen dessert mix outside Massachusetts and
			 sells such products in Massachusetts;
(8) Manufactures or bottles within
			 Massachusetts carbonated non-alcoholic beverages or bottled water, whether
			 carbonated or non-carbonated, for human consumption; or engages in such
			 business outside Massachusetts and sells such products in
			 Massachusetts;
(9) Manufactures
			 juice or apple cider for sale at wholesale;
(10) Operates a cold storage or refrigerating
			 warehouse, or a food warehouse;
(11) Transports or causes to be transported
			 any bakery product into Massachusetts for the purpose of sale; or
(12) Manufactures, processes, or distributes
			 any food not specifically named in 105 CMR 500.002(B)(1) through (11),
			 including dietary supplements, for sale at wholesale.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Section 500.004 - Federal Regulations Applicable to All Licensees and Permit Holders

Current through Register 1525, July 5, 2024
All licensees and permit holders shall comply with all federal
				regulations that are applicable to the type of food processing that they
				conduct. Such regulations include but are not necessarily limited to the
				following.
(A)
Food
			 Processing
.
(1) 21 CFR Part 106:
			 Infant Formula Quality Control Procedures;
(2) 21 CFR Part 110.00:
Current Good
			 Manufacturing Practice in Manufacturing, Packing or Holding Human
			 Food
;
(3) 21 CFR Part 111:
Current Good Manufacturing Practice in Manufacturing, Packaging,
			 Labeling, or Holding Operations for Dietary Supplements
;
(4) 21 CFR Part 113.00:
Thermally
			 Processed Low-acid Foods Packaged in Hermetically Sealed Containers
,
			 and
			 21
			 CFR §
										108.35:
Thermal Processing
			 of Low-acid Foods Packaged in Hermetically Sealed
			 Containers;
(5) 21 CFR
			 Part 114.00:
Acidified Foods
, and
			 21 CFR §
										108.25:
Acidified
			 Foods
;
(6)
									21
			 CFR 173.315:
Chemicals Used in
			 Washing or to Assist in the Peeling of Fruits and
			 Vegetables
;
(7)
Enforcement of
			 105
			 CMR 500.005(A)(1) through
			 (6)
. When the Department
			 receives a complaint alleging a violation of any provision of 105 CMR
			 500.004(A)(1) through (6) with respect to a business that participates in
			 interstate commerce, the Department may refer the complainant to the U.S. Food
			 and Drug Administration or take other appropriate action.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Section 500.005 - Additional Requirements for Good Manufacturing Practices Applicable to All Licensees and Permit Holders[1]

Current through Register 1525, July 5, 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.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Section 500.006 - Labeling of Food

Current through Register 1525, July 5, 2024
(A) All packaged
			 food products shall comply with the federal labeling regulations specified in
			 105
			 CMR 500.004(B) and (C), and
			 shall be labeled in accordance with all additional relevant state and/or
			 federal labeling requirements.
(B)
Open Date Labeling
.
(1)
Open Dating of Perishable and
			 Semi-perishable Food Products
.
(a) No person shall sell, offer for sale, or
			 have in his or her possession with intent to sell any prepackaged perishable or
			 semi-perishable food products unless it is identified with an open date
			 determined by the manufacturer, processor, packer, repacker, retailer, or other
			 person who packaged such food products, and which is displayed in the form
			 specified in 105 CMR 500.006(B)(5).
(b) No person receiving a perishable or
			 semi-perishable product in bulk intended for use as a repacked product or as a
			 component of a larger food item shall offer such item for prepackaged retail
			 self-service sale without placing an open date on such product, and the date
			 shall be no later than the date specified on the bulk container from which it
			 was obtained.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Section 500.007 - Transportation of Food

Current through Register 1525, July 5, 2024
(A) The licensee or
			 permit holder shall ensure that the following requirements are observed,
			 whether the vehicle is operated by the licensee or permit holder, or by a
			 contracted transporter.
(B)
Design, Construction, and Maintenance
.
(1) Vehicles and trailers shall:
(a) Be designed and built to facilitate
			 locking and sealing and to prevent infestation by pests.
(b) Permit effective inspection, cleaning,
			 disinfection, and temperature control.
(c) Be maintained in a clean and sanitary
			 condition to protect the food from contamination.
(d) Be constructed to prevent waste products
			 such as iced poultry wastes from leaking onto the ground.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Section 500.008 - Prevention of Disease Transmission 2

Current through Register 1525, July 5, 2024
All licensees and permit holders shall comply with the
				following requirements.
(A) In
			 accordance with
			 21 CFR
			 110.10:
Personnel
, it is the
			 responsibility of the licensee to protect the integrity of food products by:
(1) Developing and implementing a written
			 plan for personnel health and hygiene (as part of the SSOP developed pursuant
			 to
			 105
			 CMR 500.005(H)) that ensures
			 that all personnel report to their supervisors illnesses or health conditions
			 through which there is a reasonable possibility of products, product-contact
			 surfaces, or packaging materials becoming contaminated; and
(2) Taking appropriate protective steps in
			 accordance with Department policies or directives.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Section 500.015 - Supplemental Regulations for Residential Kitchens: Wholesale Sale

Current through Register 1525, July 5, 2024
(A)
Scope
.
(1) Persons who operate a residential kitchen
			 to prepare food for sale at wholesale shall comply with 105 CMR 500.015 in
			 addition to
			 105
			 CMR 500.004 through
			 500.008.
(2) Persons who prepare food in a residential
			 kitchen for sale at retail are subject to
			 105 CMR 590.000:
State Sanitary Code Chapter X - Minimum Sanitation Standards for Food
			 Establishments
, and should consult their board of health about any
			 additional requirements and restrictions.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Section 500.016 - Supplemental Regulations for the Production of Juice and Apple Cider

Current through Register 1525, July 5, 2024
(A)
General
			 Requirements
.
(1) No person
			 shall manufacture juice or apple cider in Massachusetts for sale at wholesale
			 without a license issued by the Department or in violation of any of the
			 requirements specified in
			 105 CMR 500.000.
(2) Persons who manufacture juice in
			 Massachusetts for sale at wholesale shall comply with 21 CFR Part 120:
Hazard Analysis and Critical Control Point (HACCP)
			 Systems
.
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 500.020 - General Requirements

Current through Register 1525, July 5, 2024
(A)
Permit Requirements
. No person shall operate as a
				wholesale seafood dealer, retail seafood dealer, or wholesale seafood truck 
				3 without a valid permit issued jointly
				by the Department and the Division of Marine Fisheries. No person shall operate
				as such a dealer in violation of applicable laws or in violation of any of the
				requirements specified in
				105 CMR 500.000.
(B)
Explanation of Permit
				Categories, Additional Requirements, and Restrictions
.
(1)
Wholesale Dealer
.
(a) Allows the permit holder to acquire,
				handle, store, distribute, process, fillet, ship, and sell raw seafood
				products, whether frozen or unfrozen, in bulk or for resale from a single,
				fixed location;
(b) Allows the
				purchasing of seafood products from a harvester or commercial
				fisherman;
(c) Allows retail sales
				from a single, fixed location;
(d)
				Requires an inspection and approval from the Department before initial
				permitting; and
(e) The wholesale
				dealer is prohibited from engaging in any activity not specifically inspected
				for and approved by the Department, and endorsed on the permit.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Supplemental Regulations for Meat and Poultry Slaughter and Processing › Section 500.030 - General Requirements and Exemptions

Current through Register 1525, July 5, 2024
(A)
				All persons who operate a meat or poultry slaughter and/or processing facility
				shall comply with 105 CMR 500.030 through 500.031.
(1) Included are custom slaughter and custom
				processing operations, and persons who slaughter or process wild animals that
				have been raised commercially for wholesale, such as, but not limited to,
				rabbits, buffalo, deer, elk, and emus. These animals are included in the
				definition of livestock or poultry, and their products are included in the
				definition of meat or poultry.
(2)
				Wild-caught animals such as deer, moose,
etc
. may be processed
				at a custom facility after notification to the Department as required by 105
				CMR 500.031(K)(9)(a).
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Supplemental Regulations for Meat and Poultry Slaughter and Processing › Section 500.031 - Slaughter and Processing Facilities That Are Exempt from USDA Inspection

Current through Register 1525, July 5, 2024
(A) Any person who operates a custom
				slaughter and/or processing facility, or a facility that is otherwise exempt
				from inspection by USDA, shall comply with the additional requirements in 105
				CMR 500.031.
(B)
Transportation Cages
.
(1) Live animal holding cages shall be
				thoroughly cleaned and sanitized after each use.
(2) Live animal holding cages in facilities
				shall be equipped with waste material catch pans at the bottom of each
				cage.
(3) Transportation cages
				shall be held in an area separate from the processing area within the
				facility.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Supplemental Fluid Milk and Milk Products Regulations › Section 500.060 - General Requirements

Current through Register 1525, July 5, 2024
(A) Requirements
				for pasteurization of dairy products shall be established as administrative
				guidelines by the Department, based on the Grade "A" Pasteurized Milk Ordinance
				(PMO) published by the United States Department of Health and Human Services.
				All pasteurization plants in Massachusetts, as well as all facilities in
				Massachusetts that produce milk products, butter, or cheese, shall comply with
				the administrative guidelines. Excluded from the pasteurization requirements is
				the production of cheese made from unpasteurized milk, which must be aged a
				minimum of 60 days.
(B) No person
				shall operate a pasteurization plant without a valid license granted by the
				board of health or in violation of any of the requirements specified in
				105 CMR
				500.000.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Supplemental Fluid Milk and Milk Products Regulations › Section 500.061 - Laboratory and Analyst Certification

Current through Register 1525, July 5, 2024
Pursuant to M.G.L. c. 111, § 184A, the Department shall
				  issue certificates of approval for laboratories, and individual analysts within
				  such laboratories, to perform tests upon milk and milk products, Grade A
				  condensed or dry milk products, and Grade A condensed or dry whey. Such
				  certification shall be accomplished in accordance with administrative
				  guidelines of the Department based on the standards and procedures described in
Evaluation of Milk Laboratories, Recommendations of the United States
				  Department of Health and Human Services, Public Health Service/Food and Drug
				  Administration
.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Supplemental Fluid Milk and Milk Products Regulations › Section 500.063 - Grade A Milk and Milk Products Which May Be Sold from Outside Massachusetts

Current through Register 1525, July 5, 2024
Grade A milk and milk products from pasteurization plants
				  outside Massachusetts may be sold or served within Massachusetts if such Grade
				  A milk and milk products comply with the standards set forth in the
				  PMO.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Supplemental Fluid Milk and Milk Products Regulations › Section 500.064 - Review of Plans for Construction or Remodeling of a Pasteurization Plant, or Change in, or Expansion of, Operations at a Pasteurization Plant

Current through Register 1525, July 5, 2024
(A) When a pasteurization plant is to be
				constructed or extensively remodeled, or an existing structure is to be
				converted for use as a pasteurization plant, or an operation is to be changed
				or added, properly prepared plans and specifications for such construction,
				remodeling, or alteration, showing layout, arrangement, and construction
				materials of work areas, and the location, size, and type of fixed equipment
				and facilities, shall be submitted to the Department for approval before such
				work is begun. No work shall be started until approval is granted.
(B) After the work has been completed, the
				Department shall inspect the pasteurization plant prior to the start of
				operations to ascertain compliance with the approved plans and specifications
				and with the requirements of
				105 CMR 500.000.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Supplemental Fluid Milk and Milk Products Regulations › Section 500.065 - Certification for Interstate Shipment

Current through Register 1525, July 5, 2024
(A) In
				certifying pasteurization plants for listing on the Interstate Milk Shippers
				List (IMS List), the Department shall follow the procedures in administrative
				guidelines of the Department based on:
(1)
Procedures Governing the Cooperative State-Public Health Service/Food
				and Drug Administration Program of the National Conference on Interstate Milk
				Shipments
, published by the U. S. Department of Health and Human
				Services, the U. S. Public Health Service, the U. S. Food and Drug
				Administration, and the National Conference on Interstate Milk Shipments;
				and
(2)
Methods of Making
				Sanitation Ratings of Milk Shippers
, published by the U.S. Public
				Health Service and the U.S. Food and Drug Administration.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Supplemental Regulations for Manufacturers of Frozen Desserts, Frozen Dessert Mixes, Butter, and Cheese › Section 500.080 - Exemption for Retail Manufacture of Non-milk-based Frozen Desserts

Current through Register 1525, July 5, 2024
(A) A person who operates a retail machine
				for the manufacture of non-milk-based frozen desserts only, including but not
				limited to so-called slush or water ice, shall obtain a permit pursuant to
				105 CMR 590.000:
State Sanitary Code Chapter X - Minimum Sanitation Standards for Food
				Establishments
. Such a permit, when valid, shall be deemed to satisfy
				the requirements of
				105 CMR 500.000, and no
				separate license pursuant to
				105 CMR 500.000 shall be
				required.
(B) If such person
				already has a valid permit pursuant to
				105 CMR 590.000:
State Sanitary Code Chapter X - Minimum Sanitation Standards for Food
				Establishments
because he or she operates a food establishment, no
				separate permit for non-milk-based frozen desserts shall be required.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Supplemental Regulations for Manufacturers of Frozen Desserts, Frozen Dessert Mixes, Butter, and Cheese › Section 500.081 - General Requirements

Current through Register 1525, July 5, 2024
(A)
Regulated Activities
.
(1) Persons who engage in any of the
				following activities shall comply with 105 CMR 500.081 through 500.083, as
				appropriate, in addition to
				105
				CMR 500.004 through
				500.008.
(a) Manufacturing frozen desserts or frozen
				dessert mix within Massachusetts;
(b) Manufacturing frozen desserts or frozen
				dessert mix outside Massachusetts and selling such product(s) within
				Massachusetts;
(c) Manufacturing
				butter within Massachusetts for wholesale; or
(d) Manufacturing cheese within Massachusetts
				for wholesale.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Supplemental Regulations for Manufacturers of Frozen Desserts, Frozen Dessert Mixes, Butter, and Cheese › Section 500.082 - Testing Requirements; Enforcement

Current through Register 1525, July 5, 2024
(A)
Raw Milk to be Used in Frozen Desserts, Frozen Dessert Mixes,
				Butter, or Cheese
.
(1)
Drug Residues
.
(a)
				All manufacturers shall test for drug residues, or have evidence of a previous
				test for drug residues, on all incoming unpasteurized milk and milk products
				received for processing into frozen desserts, frozen dessert mixes, butter, or
				cheese.
(b) Drug residue tests
				shall be performed as required by the Department's administrative guidelines
				based on the PMO.
(c) The
				manufacturer shall not use any item tested until it receives a negative test
				result, provided that when drug residues have been found in a second sample of
				raw milk or a raw milk product, the manufacturer shall destroy such milk or
				milk product.
(d) Any positive drug
				residue test shall be reported to the Department of Agricultural
				Resources.
(e) Whenever a drug
				residue test is confirmed positive, the manufacturer shall investigate to
				determine the cause, and shall correct the cause in accordance with the
				guidelines.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Supplemental Regulations for Manufacturers of Frozen Desserts, Frozen Dessert Mixes, Butter, and Cheese › Section 500.083 - Chemical, Physical, Bacteriological, and Temperature Standards

Current through Register 1525, July 5, 2024
The items listed in 105 CMR 500.083:
Table 1
shall comply with the standards specified.
TABLE 1
(A) Grade "A" raw milk for pasteurization for use
								for butter or cheese (not frozen desserts)
Drug residues
No positive results as specified in administrative
								guidelines of the Department
Pesticide residues
No positive results
Freezing point
0.530 H maximum
(B) Grade "A" raw milk for pasteurization for use
								for frozen desserts
Bacterial limits
Not to exceed 100,000 per ml for individual
								supplies.
Not to exceed 300,000 per ml for commingled
								milk.
Somatic cell count
Not to exceed 750,000 per ml
Drug residues
No positive results as specified in administrative
								guidelines of the Department
Pesticide residues
No positive results
(C) Butter, whipped butter
% Butterfat
Not less than 80%
Temperature
Maintained at a temperature of 45°F (7.2°C)
								or less when in storage
Proteolytic count
Not more than 50 per gram
Yeast and mold
Not more than ten per gram
Coliform count
Not more than ten per gram
Keeping quality
Satisfactory after seven days at 70°F
								(21°C)
(D) Pasteurized milk, cream, and other fluid dairy
								products for use for frozen desserts
Bacterial limit
Not to exceed 20,000 per ml
Coliform count
Not to exceed ten per gram, except in the case of
								bulk milk transport tank shipments not to exceed 100 per ml.
Storage temperature
No higher than 45°F (7.2°C)
(E) Frozen dessert mix
Bacterial limit
30,000 per ml
Coliform count
Not to exceed ten per gram, except in the case of
								bulk milk transport tank shipments not to exceed 100 per ml.
Storage temperature
No higher than 45°F (7.2°C), except that
								sterile or aseptic mix has no storage temperature requirement.
(F) Frozen desserts
Bacterial limit
30,000 per ml
Coliform count
Other than soft-serve: not to exceed 20 per gram
								Soft-serve: not to exceed 50 per gram
Storage temperature
No higher than 10°F (-12°C)
Milkfat
Standards listed in 21 CFR Part 135
(G) Private water supplies for milk pasteurization
								plants; Recirculated cooling water (sweet water); Glycol for cooling
Coliform count
than 1.1 per 100 ml as MPN or equivalent method
								less than 1 per 100 ml
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Supplemental Regulations for the Manufacture, Collection, Bottling, and Labeling of Bottled Water and Carbonated Non-alcoholic Beverages › Section 500.090 - General Requirements

Current through Register 1525, July 5, 2024
(A) No person
				within Massachusetts shall manufacture or bottle carbonated non-alcoholic
				beverages or bottled water, whether carbonated or non-carbonated, for human
				consumption without a license issued by the board of health or in violation of
				the terms of the license or any of the requirements specified in
				105 CMR 500.000.
(B) No person engaged outside Massachusetts
				in the business of manufacturing or bottling carbonated non-alcoholic beverages
				or water, whether carbonated or non-carbonated, for human consumption shall
				sell any such product in Massachusetts without a license issued by the
				Department or in violation of the terms of the license or any of the
				requirements specified in
				105 CMR 500.000.
(C) No person shall use water from a
				particular water source in bottling bottled water or carbonated non-alcoholic
				beverages unless that source and any treatment of that source have a current
				approval from the Department or the relevant out-of-state
				jurisdiction.
(D) No person shall
				sell or exchange, deliver, advertise, or offer for sale or exchange any bottled
				water or carbonated non-alcoholic beverage unless the manufacturer and bottler
				of such product hold a valid license from the board of health or the
				Department.
(E) All persons who
				manufacture or bottle bottled water, whether carbonated or non-carbonated, for
				human consumption shall comply with all applicable federal regulations,
				including but not limited to the following sections of the federal regulation
				21 CFR Part 129:
Processing and Bottling of Bottled Drinking
				Water
:
(1) Subpart A -
General Provisions
;
(2) Subpart B -
Buildings and
				Facilities
, sections 129.20, 129.35(a)(4)(iii), and 129.37;
(3) Subpart C -
Equipment
;
				and
(4) Subpart E -
Production and Process Controls
.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Supplemental Regulations for the Manufacture, Collection, Bottling, and Labeling of Bottled Water and Carbonated Non-alcoholic Beverages › Section 500.092 - Quality Standards for Bottled Water and Carbonated Non-alcoholic Beverages

Current through Register 1525, July 5, 2024
(A)
Source Water
.
				All source water shall comply with applicable requirements of
				310 CMR
				22.00:
Drinking Water
, promulgated by
				DEP, and with any additional maximum contaminant levels promulgated by EPA and
				in effect. Source water may be treated to reduce the level of a contaminant or
				drinking water constituent.
(B)
Finished Products: Bottled Water
.
(1) The finished product shall conform to the
				standards of quality in
				21
				CFR §
											165.110(b).
(2) Finished products, the quality of which
				is below that prescribed by any standard of quality in
				21
				CFR §
											165.110(b)
				(
i.e
. substandard products), shall not be sold or distributed
				in any manner in Massachusetts.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Supplemental Regulations for the Manufacture, Collection, Bottling, and Labeling of Bottled Water and Carbonated Non-alcoholic Beverages › Section 500.093 - Sampling and Testing Requirements for Bottled Water and Carbonated Non-alcoholic Beverages

Current through Register 1525, July 5, 2024
(A)
Sampling and Testing Procedures
.
(1)
Source Water
.
				105 CMR 500.093(A)(1) applies to both bottled water and carbonated
				non-alcoholic beverages, except that 500.093(A)(1)(d) applies only to bottled
				water.
(a) The raw water from the source
				shall be sampled immediately after it is withdrawn from the source, and
				analyzed to characterize its microbiological, physical, radiological, and
				chemical quality. If any of the analyses show the water not to be in compliance
				with the quality requirements specified in 105 CMR 500.092(A), the water shall
				be treated to meet the requirements of 105 CMR 500.092(A) and shall be tested
				after treatment. Sampling and analysis shall be performed as often as
				necessary, but at a minimum frequency of:
1.
				Once each year for chemical and physical contaminants;
2. Once every four years for radiological
				contaminants, or as otherwise specified by the Department; and
3. Once each week for microbiological
				contaminants.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Supplemental Regulations for the Manufacture, Collection, Bottling, and Labeling of Bottled Water and Carbonated Non-alcoholic Beverages › Section 500.094 - Bulk Storage and Transportation of Water

Current through Register 1525, July 5, 2024
All bottled water and carbonated non-alcoholic beverage
				  facilities shall comply with the following requirements in addition to the
				  transportation requirements in
				  105 CMR
				  500.007.
(A)
General
. A
				bottled water or carbonated non-alcoholic beverage facility shall not accept
				water for use in its products unless the facility and the bulk water
				transporter, as appropriate, comply with the following requirements.
(1) Bulk storage tanks and related equipment
				shall be cleaned, sanitized, and inspected internally for integrity on a
				routine basis in compliance with the sanitary standards in 21 CFR Parts 110:
Current Good Manufacturing Practice in Manufacturing, Packaging or
				Holding Human Food
and 129:
Processing and Bottling of Bottled
				Drinking Water
. A record of all cleaning and sanitizing showing the
				date, time, place, and signature or initials of the person doing the work shall
				be maintained with the storage tank. If someone other than an employee of the
				licensee does the work, a copy of the record shall be given to the licensee and
				kept at the facility for at least six months. The facility shall provide these
				records to the Department upon request.
(2) Equipment used for transport of bulk
				water shall not be used, and shall not have been used previously, for any
				non-food product. Such equipment shall not be used for any dairy product or
				non-beverage food except in an emergency. If the equipment is used for any food
				or beverage other than bulk potable water, it shall be cleaned and sanitized as
				required by 21 CFR Parts 110:
Current Good Manufacturing Practice in
				Manufacturing, Packaging or Holding Human Food
and 129:
Processing and Bottling of Bottled Drinking Water
immediately
				before the water is loaded.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Administration and Enforcement › Section 500.200 - General Administration

Current through Register 1525, July 5, 2024
(A) The following
				provisions shall govern the administration and enforcement of
				105 CMR 500.000, except
				when an applicable statute requires a different procedure.
(B) The Department may publish
				interpretations of
				105 CMR 500.000 and
				guidelines as it deems necessary to promote uniform application of
				105 CMR 500.000, and may
				make them available to those persons subject to
				105 CMR 500.000.
(C) In addition to the specific enforcement
				provisions in 105 CMR 500.021(G), 500.065, 500.082, and 500.093, the regulatory
				agency may enforce
				105 CMR 500.000 by issuing
				a Notice of Violation/Order to Correct Violations and/or an Order to Cease and
				Desist operation of a facility and/or a specific operation within a facility,
				or by commencing an enforcement action pursuant to 105 CMR 500.207 and
				500.208.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Administration and Enforcement › Section 500.202 - Operating Without a License, Permit, Approval, or Certification

Current through Register 1525, July 5, 2024
(A) The regulatory agency may inspect any
				facility which it has reason to believe contains an operation subject to
				regulation pursuant to
				105 CMR 500.000.
(B) The regulatory agency may issue an Order
				to Cease and Desist to any person engaged in an activity subject to regulation
				pursuant to
				105 CMR 500.000 who is
				operating without a required license, permit, approval, or
				certification.
(C) The regulatory
				agency may deny an application for a license, permit, approval, or
				certification when the applicant was previously engaged in an activity subject
				to regulation pursuant to
				105 CMR 500.000 without a
				required license, permit, approval, or certification.
(D) If allowed by statute, the Department may
				impose civil monetary penalties against a facility subject to licensure that is
				found to be operating without the required license, permit, approval, or
				certification.
(E) The regulatory
				agency may petition the Superior Court to enjoin the operation of a facility
				operating without a required license, permit, approval, or
				certification.
(F) The regulatory
				agency may take such other steps as required to bring a person operating
				without a required license, permit, approval, or certification into compliance,
				or to terminate the operation of the facility or any portion of the facility,
				in order to protect the health and safety of the public.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Administration and Enforcement › Section 500.203 - Inspections

Current through Register 1525, July 5, 2024
(A)
Inspections; Applicable
				Regulatory Agency
. The following types of food-related operations
				are routinely subject to inspection by the following regulatory agencies.
(1) A person who operates a residential
				kitchen that prepares food for wholesale sale: inspection by the
				Department.
(2) A person who
				operates as a retail seafood dealer: inspection by the board of health or the
				Department.
(3) A person who
				operates as a wholesale seafood dealer or who operates a wholesale seafood
				truck: inspection by the Department.
(4) A person who cooks, smokes, or otherwise
				processes seafood, or combines seafood with non-seafood ingredient(s) for sale
				at wholesale: inspection by the Department.
(5) A person who slaughters livestock or
				poultry, processes meat or poultry for sale at wholesale, custom slaughters
				livestock or poultry, or custom processes meat or poultry: inspection by the
				Department.
(6) A person who
				operates a milk pasteurization plant: inspection by the Department.
(7) A person who manufactures butter or
				cheese in Massachusetts for sale at wholesale in a facility separate from a
				pasteurization plant: inspection by the Department.
(8) A person who manufactures frozen desserts
				or frozen dessert mix within Massachusetts for sale at wholesale: inspection by
				the Department.
(9) A person who
				manufactures frozen desserts or frozen dessert mix within Massachusetts for
				sale at retail: inspection by the board of health.
(10) A person who, within Massachusetts,
				manufactures or bottles carbonated non-alcoholic beverages or bottled water,
				whether carbonated or non-carbonated, for human consumption: inspection by the
				Department.
(11) A person who
				manufactures juice or apple cider for sale at wholesale: inspection by the
				Department.
(12) A person who
				manufactures or processes any food not specifically named in 105 CMR
				500.203(A)(1) through (11) for sale at wholesale: inspection by the
				Department.
(13) A person who
				operates a cold storage or refrigerating warehouse: inspection by the
				Department or the local board of health.
(14) A person who operates a food warehouse:
				inspection by the Department.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Administration and Enforcement › Section 500.204 - Notice of Violations/Order to Correct

Current through Register 1525, July 5, 2024
(A)
				Whenever the regulatory agency finds upon inspection, investigation of a
				complaint, or through information in its possession that an applicant,
				licensee, or permit holder is not in compliance with any of the provisions of
				105 CMR 500.000, the
				regulatory agency shall notify such person of each violation or deficiency. The
				notice shall include a statement of the violations or deficiencies found; the
				provisions of the law relied upon; the level of severity of the violation or
				deficiency, when appropriate; a reasonable period of time for correction; and
				notice that a violation or deficiency may result in a refusal to issue or renew
				or a suspension or revocation of a license, permit, or approval; a modification
				or limitation of a license, permit, or approval; an order to cease and desist;
				and/or the imposition of fines and/or administrative penalties, as
				applicable.
(B) The reasonable
				period of time for correction shall be within the discretion of the regulatory
				agency to establish in each instance, and shall be based on an evaluation of
				the type and the severity of each violation or deficiency.
(C) The inspection report may, if so stated,
				constitute the Notice of Violations/Order to Correct all violations or
				deficiencies indicated, or the regulatory agency may issue a separate
				Notice/Order. Both the inspection report and the Notice of Violations/Order to
				Correct shall constitute
prima facie
evidence of the
				violations stated therein.
(D) If
				critical violations are found, or if after review or reinspection the
				regulatory agency finds that the violations have not been corrected, the
				regulatory agency may issue a prescriptive order stating specific actions that
				the facility must take to correct the violations. The regulatory agency shall
				document the conditions that necessitate the specific actions.
(E)
Service of the Notice of
				Violations/Order to Correct
.
(1)
				Service shall be in person to the person in charge at the time of the
				inspection; or by certified mail, return receipt requested, to the address on
				file with the regulatory agency; or by any officer of the Commonwealth
				authorized to make service.
(2) If
				served personally, notice is deemed to be served on the date when the Notice of
				Violations/Order to Correct is delivered personally.
(3) If served by certified mail, return
				receipt requested, notice is deemed to be served on the second business day
				after it is mailed.
(4) Notice is
				deemed served if the applicant, licensee, permit holder, or person in charge
				has actual notice.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Administration and Enforcement › Section 500.205 - Plan of Correction

Current through Register 1525, July 5, 2024
(A) The applicant,
				licensee, or permit holder, within the time specified in the Notice of
				Violations/Order to Correct, shall file a written plan of correction, certified
				under the pains and penalties of perjury.
(B) Each plan of correction shall:
(1) State the name of the applicant,
				licensee, or permit holder and the name of the individual and address for
				receipt of notices;
(2) Reference
				each violation or deficiency cited, and for each indicate:
(a) The specific corrective action completed
				and the date the work was completed; and/or
(b) Where corrective action was not yet
				completed, the specific corrective action planned and the timetable and date
				for completion, which is in accordance with the date indicated in the Notice of
				Violations/Order to Correct; and
(3) Include the date and the signature of the
				applicant, licensee, or permit holder or his or her official designee, sworn to
				under the pains and penalties of perjury.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Administration and Enforcement › Section 500.206 - Order to Cease and Desist

Current through Register 1525, July 5, 2024
(A) An Order to
				Cease and Desist may be issued to the licensee, permit holder, person in
				charge, or operator upon belief that:
(1) An
				operator is conducting a food operation without the required license, permit,
				approval, or certification; or
(2)
				A licensee or permit holder is conducting its operation in violation of the
				law, regulations, and/or standards applicable to it; or
(3) A licensee or permit holder refuses
				access to the premises and/or records to authorized enforcement agents;
				or
(4) A licensee or permit holder
				is operating in a manner that may pose an imminent danger to the public health;
				or
(5) The licensee or permit
				holder has violated an embargo order; or
(6) The licensee or permit holder has failed
				to comply with an Order to Correct within the time specified; or
(7) The licensee or permit holder is
				operating in a manner that is unsafe, unsanitary, or otherwise below the
				accepted standards for the type of operation for which the license, permit, or
				approval was issued and summary closure is authorized by statute on these
				grounds.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Administration and Enforcement › Section 500.207 - Grounds for Administrative Enforcement Action

Current through Register 1525, July 5, 2024
(A)
Grounds for Refusal to Issue
				a License, Permit, or Certification
.
(1) The regulatory agency may refuse to issue
				a license, permit, or certification based on any one or more of the following
				grounds. Each of the following grounds shall constitute full and adequate
				grounds to refuse to issue a license or permit.
(a) Failure to submit a timely application in
				accordance with the regulatory agency's procedures;
(b) Failure to submit the required
				fee;
(c) Failure to comply with any
				applicable statute, with any applicable provision of
				105 CMR 500.000, or with
				any lawful order of the regulatory agency or the Commissioner;
(d) Denial of entry to agents of the
				regulatory agency, or any attempt to impede the work of a duly authorized agent
				or representative of the regulatory agency;
(e) Providing a false or misleading statement
				to the regulatory agency, or keeping or submitting any misleading or false
				records or documents pertaining to the subject business, or failing to keep
				records required to be kept;
(f)
				The applicant operated the business or any business without a required license
				or permit or after the expiration of the same;
(g) The applicant or, if the applicant is a
				corporation, a corporate officer or the owner of the business has been
				convicted of, pled guilty or
nolo contendere
to, or has, in a
				judicial proceeding, admitted facts sufficient to find that he or she is guilty
				of a crime relating to the procuring, possessing, processing, storage,
				distribution, or sale of food in connection with the business;
(h) The applicant or, if the applicant is a
				corporation, a corporate officer or the owner of the business has engaged in
				conduct that endangers the public health;
(i) A business owned or operated by the
				applicant is, or was, the subject of a proceeding(s) which is still ongoing or
				resulted in the suspension, denial, or revocation of a license or permit, or
				refusal to renew the same;
(j)
				Failure to comply with all Massachusetts laws relating to taxes, reporting of
				employees and contractors, and withholding and remitting of child support as
				required by M.G.L. c. 62C, § 49A;
(k) Failure to pay administrative penalties
				or fines assessed by the regulatory agency in a timely manner; or
(l) Failure to comply with local regulations,
				bylaws, or ordinances related to the operation of the business.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Administration and Enforcement › Section 500.208 - Procedures for Administrative Enforcement Action

Current through Register 1525, July 5, 2024
(A)
Notice of Agency
				Action
.
(1) Whenever the
				regulatory agency determines to suspend with notice, revoke, refuse to issue,
				or refuse to renew a license, permit, or certification or to assess civil
				monetary penalties, it shall issue a Notice of Agency Action. The Notice of
				Agency Action shall be in writing and shall specify:
(a) The specific reasons(s) for which the
				particular Agency Action is to be taken, and the applicable provisions of
				law;
(b) When the particular Agency
				Action will take effect; and
(c)
				The procedure for requesting a hearing, unless no hearing is required pursuant
				to M.G.L. c. 30A, § 13 or other applicable state or federal law.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Administration and Enforcement › Section 500.209 - Embargo

Current through Register 1525, July 5, 2024
(A) Pursuant to M.G.L. c. 94, § 189A,
				the Commissioner or his or her agent may place an embargo on any product which
				he or she finds or has probable cause to believe is adulterated or misbranded
				provided that:
(1) A written notice is issued
				to the licensee, permit holder, or the person in charge at the facility, or if
				no one is present at the facility, conspicuously posted at the facility;
				and
(2) The notice specifies the
				reason(s) for the embargo order.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Administration and Enforcement › Section 500.211 - Nonexclusivity of Enforcement Procedures

Current through Register 1525, July 5, 2024
None of the enforcement procedures contained in
				  105 CMR 500.000 is mutually
				  exclusive. Any enforcement procedures may be invoked simultaneously if the
				  situation so warrants.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Administration and Enforcement › Section 500.212 - Variance

Current through Register 1525, July 5, 2024
(A) The Department may vary the application
				of any provision of
				105 CMR 500.000 with
				respect to any particular case when, in its opinion, the enforcement thereof
				would do manifest injustice; provided that the decision of the Department shall
				not conflict with the purpose of
				105 CMR 500.000. The
				Department may place reasonable conditions on any variance.
(B) Copies of all variances shall be
				available to the public.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Administration and Enforcement › Section 500.213 - Severability

Current through Register 1525, July 5, 2024
The provisions of
				  105 CMR 500.000 are
				  severable. If a court of competent jurisdiction declares any section,
				  subsection, paragraph, or provision unconstitutional or invalid, the validity
				  of the remaining provisions shall not be affected.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 515.000 - Reserved

Current through Register 1525, July 5, 2024
REGULATORY AUTHORITY
105 CMR 515.000: M.G.L. c. 94, §§ 186 and 192; M.G.L.
				c. 111, §§ 5 and 6.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 520.000 - Repealed

Current through Register 1525, July 5, 2024
REGULATORY AUTHORITY
105 CMR 520.000: M.G.L. c. 94, §§ 192, 126, 10I, 65S
				through 65U, 73A, 91, 119, 125; M.G.L. c. 111, § 6.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 533.000 - Repealed

Current through Register 1525, July 5, 2024
REGULATORY AUTHORITY
105 CMR 533.000: M.G.L. c. 94, §§ 88C, 192, 305A;
				M.G.L. c. 111, §§ 3 and 5; M.G.L c. 130, § 80.