CHAPTER He-P 2100  BEVERAGES AND BOTTLED WATER

 

PART He-P 2101  DEFINITIONS

 

          He-P 2101.01  Definitions.

 

          (a)  “Adequate” means that which is needed to accomplish the intended purpose.

 

          (b)  “Approved source” means the source(s) of the water and the water therefrom, which has been approved by the New Hampshire department of environmental services (DES) in accordance with RSA 143:16 or RSA 485:3.

 

          (c)  “Artesian water” means “artesian water” as defined in 21 CFR 165.110 (a)(2)(i), namely “water from a well tapping a confined aquifer in which the water level stands at some height above the top of the aquifer.”

 

          (d)  “Beverages” means “beverage” as defined in RSA 143:9, namely “all still and carbonated drinks, fruit juices and all beverages compounded therefrom; all bottled waters, whether for medicinal or table use; and all packaged liquids intended for use in the manner of drink.  Milk and unmixed products thereof, and fruit juices and waters retailed exclusively by the producer or manufacturer direct, are not included.”

 

          (e)  “Bottled water” means “bottled water” as defined in 21 CFR 165.110(a)(1).

 

          (f)  “Bottler” means any person, firm, or corporation engaging in the business of bottling beverages and/or water for sale or distribution.

 

          (g)  “Bulk water” means a source of water, not bottled by its owner, but which is transported via tanker truck or an equivalent means from one area to another for the purpose of treatment, packaging and human consumption.

 

          (h)  “Commissioner” means the commissioner of the New Hampshire department of health and human services or his or her designee.

 

          (i)  “Compliant facility” means a facility that achieves a score of 90 or greater on an inspection, in accordance with He-P 2108.01.

 

          (j) “Corrosion resistant material” means those materials that maintain their original surface characteristics when exposed to the conditions encountered during intended use including expected contact with product and cleaning, sanitizing or sterilization compounds or solutions.

 

          (k)  “Deionized water” means “deionized water” as defined in 21 CFR 165.110(a)(2)(iv), namely water that “has been processed by deionization.”

 

          (l)  “Demineralized water” means “demineralized water” as defined in 21 CFR 165.110(a)(2)(iv), namely “water that has been produced by distillation, deionization or reverse osmosis, or other suitable processes and that meets the definition of ‘purified water’ in the United States Pharmacopeia, 23rd Revision, January 1, 1995.”

 

          (m)  “Department” means the New Hampshire department of health and human services.

 

          (n)  “Distilled water” means “distilled water” as defined in 21 CFR 165.110(a)(2)(iv), namely water that “has been produced by distillation.”

 

          (o)  “Imminent health hazard” means a significant threat or danger to health that is considered to exist when there is evidence sufficient to show that a product, practice, circumstance or event creates a situation that requires immediate correction or cessation of operation to prevent injury, based on the number of potential injuries and the nature, severity and duration of the anticipated injury.

 

          (p)  “Mineral water” means “mineral water” as defined in 21 CFR 165.110(a)(2)(iii), namely “water containing not less than 250 parts per million (ppm) total dissolved solids (TDS) coming from a source tapped at one or more bore holes or springs, originating from a geologically and physically protected underground water source.”

 

          (q)  “Multiservice containers” means containers intended for use more than one time.

 

          (r)  “Natural water” means ground water that is not modified in its mineral content by addition or subtraction except the modification that might occur through minimal treatment such as filtration, aeration, ozonation, ultraviolet light or equivalent disinfection processes intended to remove undesirable elements.

 

          (s)  “Non-compliant facility” means a facility that scores less than 90 on an inspection, in accordance with He-P 2108.01.

 

          (t)  “Nontoxic materials” means materials for product contact surfaces utilized in the transporting, processing, storing and packaging of bottled beverages or drinking water, which are free of substances which could render the water injurious to health or which could adversely affect the flavor, color, odor or bacteriological quality of the beverage or water.

 

          (u)  “Operations water” means water which is delivered under pressure to a plant for container washing, hand washing, plant and equipment cleanup and for other sanitary purposes.

 

          (v)  “Person” means an individual or firm, partnership, company, corporation, trustee, association or any public or private entity.

 

          (w)  “Primary container” means the immediate container in which product water is packaged.

 

          (x)  “Processing authority” means “processing authority” as defined in 9 CFR 318.300 (q), namely “the person(s) or organization(s) having expert knowledge of thermal processing requirements for foods in hermetically sealed containers, having access to facilities for making such determinations, and designated by the establishment to perform certain functions as indicated in this subpart.”

 

          (y)  “Product water” means water that is processed by a plant for bottled drinking water or for the manufacture of beverages.

 

          (z)  “Purified water” means “purified water” as defined in 21 CFR 165.110 (a)(2)(iv), namely “water that has been produced by distillation, deionization, reverse osmosis, or other suitable processes, and which meets the definition of ‘purified water’ in the United States Pharmacopeia, 23rd Revision, January 1, 1995.”

 

          (aa) “Sanitize” means the application of cumulative heat, chemicals or equivalent processes on cleaned product contact surfaces that, when evaluated for efficacy, is sufficient to yield a reduction of 5 logs, which is equal to 99.999% reduction of representative disease microorganisms of public health importance.

 

          (ab)  “Single-service container” means a container intended for one time usage only.

 

          (ac) “Sparkling bottled water” means “sparkling bottled water” as defined in 21 CFR 165:110 (a)(2)(v), namely “water that after treatment and possible replacement with carbon dioxide, contains the same amount of carbon dioxide from the source that it had at emergence from the source.”

 

          (ad)  “Spring water” means “spring water” as defined in 21 CFR 165.110 (a)(2)(vi), namely “water derived from an underground formation from which water flows naturally to the surface of the earth.”

 

          (ae)  “Sterile water” means “sterile water” as defined in 21 CFR 165.110 (a)(2)(vii), namely “water that meets the requirements under ‘Sterility Tests’ in the United States Pharmacopeia, 23rd Revision, January 1, 1995.”

 

          (af)  “Unit package” means a standard commercial package of a beverage or bottled drinking water.

 

          (ag)  “Vended water” means water that is dispensed by a water vending machine that is not placed by a bottler in sealed containers.

 

          (ah) “Wash” means cleaning with a solution that contains soap, detergent, acid cleaner, alkaline cleaner, or other cleaning agents according to the cleaning agents manufacturing label instructions.

 

          (ai)  “Well water” means “well water” as defined in 21 CFR 165.110 (a)(2)(viii), namely “water from a hole bored, drilled, or otherwise constructed in the ground which taps the water of an aquifer.”

 

Source.  #5383, eff 4-22-92, EXPIRED: 4-22-98

 

New.  #6737, Interim, eff 4-25-98, EXPIRED: 8-23-98

 

New.  #7979, eff 10-22-03; ss by #10012, INTERIM, eff 10-22-11, EXPIRES: 4-19-12; ss by #10116, eff 4-19-12; ss by #12680, eff 11-27-18

 

PART He-P 2102  BOTTLED, BULK AND VENDED WATER

 

          He-P 2102.01  Approval of Sources for Bottled, Bulk and Vended Water.

 

          (a)  All in-state sources of water intended for use as bottled water, bulk water or vended water, including mineral water, shall be approved by the Department of Environmental Services (DES) in accordance with RSA 143:16 and Env-Dw 303 or Env-Dw 305 or Env-Dw 302 if applicable.

 

          (b)  All in-state sources of water which have been approved in accordance with Env-Dw 305 or Env-Dw 302 shall obtain written approval from DES stating that the source can be used for bottled water in addition to its previously approved use.

 

          (c)  All out-of-state and foreign water sources shall be licensed or approved by the government agency having jurisdiction.

 

          (d)  All bottled water sources shall be of safe and sanitary quality and be in conformance at all times with the applicable laws and regulations of the government agency or agencies having jurisdiction.

 

          (e)  Bottlers shall not utilize any source for bottled water until written source approval, as required in (a), (b) or (c) above, is obtained from DES or the government agency having jurisdiction if the source is located in another state or country.

 

          (f)  All sources of water approved by the department that have not maintained an annual beverage license with the department shall be required to follow He-P 2102.01(a).

 

Source.  #1930, eff 1-26-82; ss by #2599(E), eff 1-23-84, exp. 5-23-84

 

New.  #5383, eff 4-22-92, EXPIRED: 4-22-98

 

New.  #6737, Interim, eff 4-25-98, EXPIRED: 8-23-98

 

New.  #7979, eff 10-22-03; ss by #10012, INTERIM, eff 10-22-11, EXPIRES: 4-19-12; ss by #10116, eff 4-19-12; ss by #12680, eff 11-27-18

 

          He-P 2102.02  Standards of Quality for Bottled Water.

 

          (a)  All sources of water for bottled, bulk or vended water, under the regulatory authority of DES shall meet the quality standards required by DES in accordance with RSA 485:3.

 

     (b)  All finished bottled water products, regardless of state or country of origin, shall meet the FDA standards of quality for bottled water in 21 CFR 165.110(b).

 

Source.  #1930, eff 1-26-82; ss by #2599(E), eff 1-23-84, exp. 5-23-84

 

New.  #5383, eff 4-22-92, EXPIRED: 4-22-98

 

New.  #6737, Interim, eff 4-25-98, EXPIRED: 8-23-98

 

New.  #7979, eff 10-22-03; ss by #10012, INTERIM, eff 10-22-11, EXPIRES: 4-19-12; ss by #10116, eff 4-19-12; ss by #12680, eff 11-27-18

 

             He-P 2102.03  Spring Water.  Spring water shall meet all requirements set forth in 21 CFR 165.110(a)(2)(vi), as follows:

 

          (a)  Spring water, as defined in He-P 2101.01(ad), shall be collected only at the spring or through a bore hole tapping the underground formation feeding the spring;

 

          (b)  There shall be a natural force causing the water to flow to the surface through a natural orifice;

 

          (c)  The location of the spring shall be identified;

 

          (d)  Spring water collected with the use of an external force shall:

 

(1)  Be from the same underground stratum as the spring, as shown by a measurable hydraulic connection using a hydrogeologically valid method between the borehole and the natural spring; and

 

(2)  Have all the physical properties, before treatment, and be of the same composition and quality, as the water that flows naturally to the surface of the earth;

 

          (e)  If spring water is collected with the use of an external force, water shall continue to flow naturally to the surface of the earth through the spring’s natural orifice; and

 

          (f)  Plants shall demonstrate on request, to appropriate regulatory officials, using hydrogeologically valid methods, that a hydraulic connection exists between the natural orifice of the spring and the borehole.

 

Source.  #1930, eff 1-26-82; ss by #2599(E), eff 1-23-84, exp. 5-23-84

 

New.  #5383, eff 4-22-92, EXPIRED: 4-22-98

 

New.  #6737, Interim, eff 4-25-98, EXPIRED: 8-23-98

 

New.  #7979, eff 10-22-03; ss by #10012, INTERIM, eff 10-22-11, EXPIRES: 4-19-12; ss by #10116, eff 4-19-12; ss by #12680, eff 11-27-18

 

                 He-P 2102.04  Artesian Water.  Artesian water, as defined in He-P 2101.01(c), may be collected with the assistance of external force to enhance the natural underground pressure.

 

Source.  #1930, eff 1-26-82; ss by #2599(E), eff 1-23-84, exp. 5-23-84

 

New.  #5383, eff 4-22-92, EXPIRED: 4-22-98

 

New.  #6737, Interim, eff 4-25-98, EXPIRED: 8-23-98

 

New.  #7979, eff 10-22-03; ss by #10012, INTERIM, eff 10-22-11, EXPIRES: 4-19-12; ss by #10116, eff 4-19-12; ss by #12680, eff 11-27-18

 

          He-P 2102.05  Bottled Water Sample Requirements.

 

          (a)  All samples of bottled water sources or finished product shall be analyzed in a laboratory which has been certified by the Environmental Protection Agency (EPA) or which has been certified or accredited according to Env-C 300.

 

          (b)  To assure that the plant’s production of bottled water is in compliance with the quality standards set forth in He-P 2102.02, the plant ownership shall collect samples of finished product for analysis as follows:

 

(1)  For microbiological standards, analyze, at least once each week, a sample from a batch or segment of the continuous production for each type of finished bottled water produced by the plant; and

 

(2)  For chemical, physical, and radiological standards, analyze, at least once each calendar year, a sample from a batch or segment of a continuous product run for each type of finished bottled water produced by the plant.

 

          (c) The samples required by (1) and (2) above shall be derived from primary containers or unit packages of the product.

 

Source.  #12680, eff 11-27-18

 

          He-P 2102.06  Source Water.  To assure that the source used by a plant for bottled water is in compliance with the quality standards set forth in He-P 2102.02, the plant or bulk source ownership shall collect or direct the collection of samples of source water for analysis, in accordance with 21 CFR 129.35, as follows:

 

          (a)  For chemical and physical standards, samples of source water shall be collected and analyzed at least once each calendar year;

 

          (b)  For radiological standards, samples of source water shall be collected and analyzed at least once every 4 years; and

 

          (c)  For microbiological standards, samples of source water shall be collected and analyzed at least once each calendar year if the source is a public water supply, or once each week if the source is not a public water supply.

 

Source.  #12680, eff 11-27-18

 

          He-P 2102.07  Analysis Results.

 

          (a)  Sample analysis results shall be maintained at the plant for at least 2 years.

 

          (b)  The plant ownership shall make all analysis results available for review by the commissioner or an agent of the commissioner.

 

          (c)  Whenever any sampling result indicates that a water sample contains contaminants above the quality standards set forth in He-P 2102.02 or a bottler has reason to believe that a substance might be present in a water source or finished product that might cause a product to be a reportable food, as defined in 21 USC 350f.417(a)(2), the person responsible for the bottling plant shall:

 

(1)  File an oral report with the department within 24 hours; and

 

(2)  File a written report to the department within 3 days that explains the contamination levels and what action was taken by the ownership because of the contaminant level.

 

          (d)  When a water sample result does not meet the quality standard as set forth in He-P 2102.02, bottling plant personnel shall conduct additional testing as follows:

 

(1)  For microbiological samples test results which show coliform bacteria in the water, samples shall be tested at least 2 times each week on non-consecutive days for one month following the original sample and after any corrective actions have been taken;

 

(2)  For chemical, physical and radiological contaminants, samples shall be tested at least once each month for 3 months following the original sample and after any corrective actions have been taken; and

 

(3) The plant or bulk source ownership shall submit results of all follow-up tests to the department.

 

Source.  #12680, eff 11-27-18

 

PART He-P 2103 BEVERAGE AND BOTTLED WATER FACILITIES, EQUIPMENT AND OPERATIONS

 

          He-P 2103.01  Construction and Design of Building and Facilities.

 

          (a)  Floors, walls and ceilings shall be tight, impervious, easily cleanable, and maintained in good repair.

 

          (b)  Floors in the bottling area shall be graded to drain.

 

          (c)  All drains shall be properly trapped to prevent access of odors and sewer gases into the plant.

 

          (d)  All doors into the bottling area shall be solid, tight, and self-closing.

 

          (e)  All outer openings into the plant operation and storage areas shall be tight to prevent access by insects and rodents.

 

          (f)  All outer doors into the facility shall be solid, tight, and self-closing.

 

          (g)  Ventilation shall be provided to minimize odors and condensation in processing rooms, bottling areas, and in container washing and sanitizing areas.

 

          (h)  The intake of all pressure ventilation systems shall be properly filtered to remove particulate contamination.

 

          (i)  There shall be no cross-connections between beverages or product water and any non-potable water supplies.

 

          (j)  If the product is bottled water, there shall be no cross-connections between the operations water and the product water.

 

          (k)  The washing and sanitizing operation shall be positioned so as to minimize any possible post-sanitizing contamination of the containers before they are filled.

 

          (l)  Rooms in which beverages or water are handled, processed, or held, or in which containers, utensils, or equipment are washed or held, shall not open directly into any living quarters.

 

          (m)  When employee locker and lunch rooms are provided, they shall be kept clean and be separated from plant operations and storage areas with self-closing doors.

 

          (n)  Hand wash stations shall be provided in locations convenient to the processing room, locker rooms, and lunch rooms, and be equipped with soap, paper towels or electric hand dryers, and hot and cold or warm running water.

 

          (o)  Restrooms shall be maintained in a clean and sanitary manner, and in good repair.

 

          (p)  Restrooms shall be equipped as follows:

 

(1)  Hand washing facilities with hot and cold running water, soap and paper towels or air dryers shall be provided;

 

(2)  Doors shall be solid and self-closing;

 

(3)  Adequate ventilation shall be provided to minimize odors and condensation;

 

(4)  Ventilation ducts shall vent to the outside; and

 

(5)  All windows shall be effectively screened against entry by insects when open.

 

          (q)  Signs shall be posted in all rest rooms, locker rooms, and lunch rooms reminding employees to wash hands before starting or returning to work.

 

          (r)  Disposal of sewage and other wastes shall be in a public sewage system or in a manner in compliance with state and local regulations.

 

          (s)  All plumbing shall be sized, installed, and maintained according to the provisions of the State of New Hampshire building code as authorized by RSA 155-A.

 

          (t)  Each facility shall be equipped with a minimum of a 2-compartment sink of adequate size to wash, rinse, and sanitize manually washed equipment and be installed and plumbed according to the State of New Hampshire building code as authorized by RSA 155-A.

 

          (u)  The premises shall be maintained free of insects, rodents, and other pests. The presence of insects, rodents and other pests shall be controlled to eliminate their presence.

 

          (v) Each facility shall provide adequate lighting and proper shielding to prevent product contamination.

 

          (w)  Private water supply wells shall be properly constructed and maintained in accordance with NH water well board rules We 100-1000.

 

          (x)  The beverage facility shall be maintained in clean and good repair.

 

Source.  #1682, eff 12-21-80; ss by #1930, eff 1-26-82; ss by #3069, eff 7-23-85; ss by #4658, eff 7-31-89; ss by #5383, eff 4-22-92, EXPIRED: 4-22-98

 

New.  #7979, eff 10-22-03; ss by #10012, INTERIM, eff 10-22-11, EXPIRES: 4-19-12; ss by #10116, eff 4-19-12; ss by #12680, eff 11-27-18

 

          He-P 2103.02  Equipment.

 

          (a)  All plant equipment and utensils shall be suitable for their intended use and in sound condition.

 

          (b)  Self contained units for washing, sanitizing, and filling multiservice containers shall be located in a properly designed and constructed facility, in accordance with He-P 2103.01.

 

          (c)  All product contact surfaces, including containers and closures, shall be constructed of nontoxic, nonabsorbent and corrosion resistant materials.

 

          (d)  Storage tanks shall be of the type that can be closed to exclude all foreign matter, and have properly protected vents.

 

Source.  #1682, eff 12-21-80; ss by #1930, eff 1-26-82; ss by #3069, eff 7-23-85, EXPIRED: 7-23-91

 

New.  #7979, eff 10-22-03; ss by #10012, INTERIM, eff 10-22-11, EXPIRES: 4-19-12; ss by #10116, eff 4-19-12; ss by #12680, eff 11-27-18

 

          He-P 2103.03  Cleaning and Sanitizing.

 

          (a)  The product contact surfaces of all multiservice containers, utensils, pipes, fillers, and equipment used in the transportation, processing, handling, and storage of beverages or water shall be:

 

(1)  Washed and rinsed after each use and shall be sanitized just prior to being used;

 

(2)  Inspected as often as necessary by plant personnel to maintain the sanitary condition of such surfaces and to assure they are kept free of scale, oxidation, and other residue or foreign matter; and

 

(3)  Cleaned immediately if the inspection shows the presence of any unsanitary condition, scale, residue, or oxidation.

 

          (b)  After cleaning, all multiservice containers, utensils, and disassembled piping and equipment shall be transported and stored in a self draining position.

 

          (c)  Mechanical washers shall be inspected as often as is necessary to assure adequate performance.

 

          (d)  Filling equipment used for bottled beverages shall not be used for any non-beverage foods.

 

          (e)  When filling equipment used for bottled water is also utilized for other beverages, such equipment shall be thoroughly washed, rinsed, and sanitized before being used for water.

 

          (f)  Fillers, storage tanks, piping, and any other processing equipment used for non-food products shall not be used for beverages or bottled water.

 

          (g)  Any methods prescribed in 21 CFR 129.80(d) or any subsequent amendments thereto, shall be considered the minimum levels to effect proper sanitization.

 

          (h)  All chemical sanitizers shall be approved by the EPA, registered, and used according to the label.

 

Source.  #7979, eff 10-22-03; ss by #10012, INTERIM, eff 10-22-11, EXPIRES: 4-19-12; ss by #10116, eff 4-19-12; ss by #12680, eff 11-27-18

 

          He-P 2103.04  Product and Operations Water.

 

          (a)  All product water that is used for bottled water shall be from an approved source as required in He-P 2102.01.

 

          (b)  All product and operations water shall be:

 

(1)  From a source which is properly located, protected, and operated to avoid contamination;

 

(2)  Of adequate quantity; and

 

(3)  Analyzed at least annually for bacteria, nitrates, and nitrite to assure the water is of a safe, sanitary quality.

 

          (c)  All treatment of product water by distillation, ion-exchange, filtration, ultraviolet treatment, ozonation, reverse osmosis, carbonation, mineral addition, or any other process shall be done in a manner so as to be effective in accomplishing its intended purpose and in accordance with section 409 of the Federal Food, Drug, and Cosmetic Act.

 

          (d)  All such treatment processes shall be performed in and by equipment designed for the purpose and with substances which will not adulterate the product water.

 

          (e)  Product water samples shall be taken after processing and prior to bottling by the plant and analyzed as often as necessary to assure uniformity and effectiveness of the treatment processes.

 

          (f)  Water that has been treated with ozone for purposes of disinfection shall not exceed 0.4 mg/l of residual ozone in the bottled water.

 

Source.  #7979, eff 10-22-03; ss by #10012, INTERIM, eff 10-22-11, EXPIRES: 4-19-12; ss by #10116, eff 4-19-12; ss by #12680, eff 11-27-18

 

          He-P 2103.05  Filling and Capping.

 

          (a)  Filling, capping, and sealing of all beverage and bottled water containers shall be done in a sanitary manner.

 

          (b)  The performance of the filler, capper, or sealer shall be monitored and the filled containers visually or electronically inspected.

 

          (c)  Single-service or multiservice containers which are damaged or defective shall not be used.

 

          (d)  Whenever air under pressure is directed at the beverage or product water or a product contact surface:

 

(1)  It shall be from a filtered source and be free of oil, dust, rust, moisture, and extraneous materials;

 

(2)  It shall not affect the bacteriological or chemical quality of the beverage or water; and

 

(3)  It shall not adversely affect the flavor, color or odor of the beverage or water.

 

          (e)  Single-service containers and caps or seals shall be stored in an enclosed container in an area that is clean and dry.

 

          (f)  Packaging or wrapping material or other processing supplies shall not be stored in locker or lunch rooms.

 

          (g) The facility shall have controls in place to ensure containers and closures are free from contamination prior to being used for filling.

 

Source.  #7979, eff 10-22-03; ss by #10012, INTERIM, eff 10-22-11, EXPIRES: 4-19-12; ss by #10116, eff 4-19-12; ss by #12680, eff 11-27-18

 

             He-P 2103.06  Record Keeping.

 

          (a)  The plant shall maintain the following records:

 

(1)  Analysis results of all required testing of the water, along with sampling date, type of product sampled, and production code;

 

(2)  Sanitization records including the date of sanitization, intensity of the sanitizing agent, and the duration of time the agent was in contact with the item or surfaces being sanitized;

 

(3)  Kind of product, volume produced, date produced, production code used, the source(s) used, if the plant bottles water from more than one source, and the distribution of the finished product to wholesale or retail outlets; and

 

(4)  Plants which treat water with methods prescribed in 21 CFR 129.80(d) shall keep a record of the type and date of physical inspections of the treatment equipment, the conditions found and the performance and effectiveness of the treatment equipment.

 

          (b)  All records above shall be kept on file at the plant for at least 2 years.

 

          (c)  The bottling facility shall make records available to the department upon request.

 

Source.  #7979, eff 10-22-03; ss by #10012, INTERIM, eff 10-22-11, EXPIRES: 4-19-12; ss by #10116, eff 4-19-12; ss by #12680, eff 11-27-18

 

          He-P 2103.07  Product Coding.

 

          (a)  Each unit package from a batch or segment of a continuous production run of a beverage or bottled drinking water shall be identified by a production code.

 

          (b)  The production code shall identify a particular batch or segment of a continuous production run and the day produced.

 

Source.  #7979, eff 10-22-03; ss by #10012, INTERIM, eff 10-22-11, EXPIRES: 4-19-12; ss by #10116, eff 4-19-12; ss by #12680, eff 11-27-18 (formerly He-P 2103.08)

 

          He-P 2103.08  Recall Procedure.

 

          (a)  Each bottler shall develop and maintain on file a written procedure for the recall of their product.

 

          (b) The recall procedure shall include procedures for the notification of the department and consumers, and removal of the product from commerce.

 

          (c)  Production records as required in He-P 2103.06(a)(3) shall be used to enable location of products if a recall is initiated.

 

          (d)  A bottler shall recall any product which the bottler or the department knows or has reason to believe might adversely affect the health and safety of the public.

 

          (e)  If the department determines that the circumstances present an imminent health hazard and that consumer notification or product recall can significantly minimize the threat to health and safety of the public, the department shall direct the bottler to initiate a product recall.

 

          (f)  The bottler shall be responsible for disseminating notification of the recall to all wholesale and retail outlets in a manner that allows quick response in an effort to protect the public health.

 

          (g)  If directed by the department, the bottler shall issue notification to consumers who might be affected by the problem using such methods, including the media, as will assure timely notification to the consumers.

 

Source.  #7979, eff 10-22-03; ss by #10012, INTERIM, eff 10-22-11, EXPIRES: 4-19-12; ss by #10116, eff 4-19-12; ss by #12680, eff 11-27-18 (formerly He-P 2103.09)

 

          He-P 2103.09  Storage and Transportation of Bulk Water for Bottling.

 

          (a) Bulk water shall be stored, loaded, transported, and unloaded in a manner that prevents contamination.

 

          (b) Facilities for the storage and transfer of bulk water for bottling shall be constructed and maintained as follows:

 

(1)  Walls and ceilings shall be tight, smooth, easily cleanable, and maintained in good repair;

 

(2)  Floors shall be smooth, impervious, graded to drain, and maintained in good repair;

 

(3)  All drains shall be properly trapped to prevent access of odors and sewer gases;

 

(4)  All outer openings shall be tight to prevent access by insects and rodents;

 

(5)  Doors shall be self-closing;

 

(6)  Ventilation shall be provided to minimize odors and condensation;

 

(7)  The intake of all pressure ventilation systems shall be properly filtered;

 

(8)  The transfer facility shall not open directly into any room which is not used as part of the water operations;

 

(9)  Hand wash stations equipped with soap, paper towels, and hot and cold or warm running water or hand sanitize stations shall be located conveniently to the transfer facility; and

 

(10)  Restrooms shall not open directly into the transfer facility.

 

          (c)  Facilities for the transfer of bulk water for bottling shall be equipped and operated as follows:

 

(1)  All equipment, including storage tanks, piping, pumps, and transport tankers shall be suitable for their intended use;

 

(2)  All product water contact surfaces shall be made of nontoxic, nonabsorbent, and corrosion resistant materials and maintained in good repair;

 

(3)  All equipment shall be cleaned, sanitized, and inspected on a routine basis;

 

(4)  Storage tanks and transport tankers shall be of the type that can be closed to exclude all foreign matter;

 

(5)  All connections, hoses, and pumps used for loading and unloading bulk water shall be stored to prevent contamination;

 

(6)  Vents on storage tanks and transport tankers shall be properly protected during filling and emptying;

 

(7)  Manhole covers on transport tankers shall be closed while filling and emptying;

 

(8)  Transport tankers used for bulk water shall not be used or have previously been used for any non-food products;

 

(9)  If the transport tanker is used for any food product containing fat or protein it shall be cleaned and sanitized immediately after such use and before it is used for bulk water;

 

(10)  Product contact surfaces of all transport tankers, storage tanks, and related equipment shall be cleaned, sanitized, and inspected as frequently as necessary to maintain the sanitary condition of such surfaces and to assure they are kept free of scale, oxidation and other residue or foreign matter; and

 

(11)  A record of all cleaning and sanitizing showing the date, time, place, and signature of person doing the work shall be maintained with the vehicle or at the bulk storage and transfer facility for a minimum of 2 years.

 

          (d)  Each shipment of bulk water shall be accompanied by a shipping statement that provides at least the following information:

 

(1)  Name and address of the owner of the source water;

 

(2)  Site of the water source;

 

(3)  Date of loading;

 

(4)  Name of facility the water is delivered to;

 

(5)  Gallons of water delivered;

 

(6)  Date and time delivered to facility; and

 

(7)  Any treatment, such as ozonation, provided at the bulk water source.

 

          (e)  The shipping statement shall be retained by the plant receiving the bulk water for at least 2 years.

 

          (f)  Upon filling, all access points to the tanker shall be sealed using a tamper evident seal printed with a unique identifier.

 

          (g)  Seals shall only be removed by the receiving plant.

 

Source.  #7979, eff 10-22-03; ss by #10012, INTERIM, eff 10-22-11, EXPIRES: 4-19-12; ss by #10116, eff 4-19-12; ss by #12680, eff 11-27-18 (formerly He-P 2103.10)

 

          He-P 2103.10  Special Requirements for Juices and Non-Carbonated Beverages.

 

          (a)  Manufacturers of juices shall comply with all applicable requirements for Hazard Analysis and Critical Control Point Systems in 21 CFR Part 120.

 

          (b)  Beverage manufacturers of non-carbonated beverages which are not subjected to heat treatment or other steps intended to consistently produce, at a minimum, a 5 log or 99.999% reduction of viable microorganisms for at least as long as the shelf life of the product, shall have a process review conducted by a processing authority on each product prior to its being produced.

 

          (c)  If the processing authority declares in writing that there are no biological concerns with the beverage after conducting the process review, the beverage shall be allowed to be produced.

 

          (d)  All products manufactured in which a process review was conducted shall be required to follow all aspects of the process review and document any required information.

 

          (e)  Manufacturers shall keep all process review information on file and retained on site for as long as the product is being manufactured. All process review information shall be available for review by the department upon request.

 

          (f)  A list of processing authorities described in (b) above, or a website link to the same, shall be available on the department’s website at http://www.dhhs.nh.gov/dphs/fp/beverage/index.htm. More extensive lists of processing authorities may be found through web search or via industry specific manufacturers’ associations.

 

Source.  #7979, eff 10-22-03; ss by #10012, INTERIM, eff 10-22-11, EXPIRES: 4-19-12; ss by #10116, eff 4-19-12; ss by #12680, eff 11-27-18 (formerly He-P 2103.11)

 

          He-P 2103.11  Alcohol Content Review.

 

          (a)  Any product that can produce alcohol shall not exceed 0.5% alcohol by volume and shall be maintained at 0.5% or below for the entirety of the listed shelf life.

 

          (b)  Testing for alcohol shall be performed on the product, at minimum, at the end of the product’s shelf life.

 

          (c)  Testing of products shall be the responsibility of the licensee and shall be tested at an accredited laboratory.

 

Source.  #7979, eff 10-22-03; ss by #10012, INTERIM, eff 10-22-11, EXPIRES: 4-19-12; ss by #10116, eff 4-19-12; ss by #12680, eff 11-27-18

 

          He-P 2103.12  Personnel.

 

          (a)  All employees shall be adequately trained and monitored by responsible supervisory personnel with regards to proper food handling procedures and the danger of poor personal hygiene and unsanitary practices.

 

          (b)  Any person who, by medical examination or supervisory observation, is shown to have, or appears to have, an illness, open lesion, including boils, sores or infected wounds, or any other abnormal source of microbial contamination by which there is a reasonable possibility of the beverage, product water, product contact surfaces, or containers or closures becoming contaminated, shall be excluded from any operations which might be expected to result in such contamination until the condition is corrected.

 

          (c)  Personnel shall report any such health conditions, described in (b) above, to their supervisors.

 

          (d)  Employees shall maintain good personal hygiene to prevent contamination.

 

          (e)  Employees shall thoroughly wash their hands and the exposed portions of their arms in an adequate hand washing facility before starting work, after each absence from the work station, and at any other time when the hands might have become soiled or contaminated.

 

          (f)  Employees shall refrain from eating food, chewing gum, drinking beverages, or using tobacco in areas where beverages or water are processed, packaged, or stored.

 

          (g)  Employees shall wear clean outer clothing.

 

          (h)  Employees shall wear, in an effective manner, hair nets, caps, beard covers, or other effective hair restraints.

 

          (i)  Employees shall remove all unsecured jewelry or other objects that might fall into equipment, or containers.

 

          (j)  Gloves, if used, shall:

 

(1)  Be impermeable;

 

(2)  Be maintained in an intact, clean, and sanitary condition; and

 

(3)  Not be a substitute for handwashing.

 

          (k)  Employees shall store all clothing or other personal belongings in areas other than where the beverages or water are processed, bottled, and stored.

 

          (l)  Employees shall take all precautions necessary to avoid the contamination of the beverages product water, product contact surfaces, containers, and closures with microorganisms or foreign substances that include perspiration, hair, tobacco, chemicals, medicines applied to the skin, and any other microorganisms and foreign substances.

 

Source.  #10116, eff 4-19-12 (from He-P 2103.11); ss by #12680, eff 11-27-18

 

          He-P 2103.13  Labeling of Beverages and Bottled Water.

 

          (a)  All labeling shall be in compliance with the applicable requirements of the federal food labeling regulations, 21 CFR Part 101, and federal bottled water regulations 21 CFR Part 165.110.

 

          (b)  The label shall state the name of the product in accordance with 21 CFR 165.110 and He-P 2103.14.

 

          (c)  When bottled water comes from a community or municipal water system, except when it has been treated by deionization, distillation, or reverse osmosis, or meets the definitions of purified or sterile water, and is labeled as such, the water shall be labeled as follows:

 

(1)  The statement “from a community water system” or, alternatively, “from a municipal source”, as appropriate, shall be on the label’s principal display panel; and

 

(2)  This statement shall immediately and conspicuously precede or follow the name of the water without intervening written, printed, or graphic matter, in type size at least one-half the size of the statement of identity but in no case less than one-sixteenth of an inch.

 

          (d)  Water labeled as sodium free, low sodium, or very low sodium shall be in compliance with labeling requirements for sodium in 21 CFR 101.61.

 

          (e)  Spring water, as defined in He-P 2101.01(ad), shall be labeled as follows:

 

(1)  The term “spring”, “springs”, or “spring water” shall not be used as a product name or a brand name on a label unless the water source meets the definition of spring water in He-P 2101.01(ad); and

 

(2)  If the word “spring” appears in the company name and the water source does not meet the definition of spring water, the word(s) designating the type of water source shall be no smaller than one-half the size of the word “spring” in the company name.

 

          (f)  Mineral water, as defined in He-P 2101.01(p), shall be labeled as follows:

 

(1)  The label for mineral water which contains total dissolved solids of less than 500 ppm shall include the statement “low mineral content”;

 

(2)  The label for mineral water which contains total dissolved solids of 1,500 ppm or higher shall include the statement “high mineral content”; and

 

(3)  Statements of low or high mineral content shall appear on the label’s principal display panel, following the statement of identity, in type size at least one-half the size of the statement of identity but in no case less than one-sixteenth of an inch.

 

          (g)  If the word “natural” appears in the company name on the label and the finished product has been subject to treatment such that it does not meet the definition of natural water in He-P 2101.01(r), the word(s) designating the type of water, such as distilled, deionized, demineralized, or drinking water, shall be no smaller than one-half the size of the word “natural” in the company name.

 

          (h)  The words in the product name on the label shall be in letters of the same style, size, and color on a background of contrasting color.

 

          (i)  Supplemental printed information and graphics on the label concerning recognized uses of the water when appearing on the label shall not infer properties of the product or preparation methods which are not factual.

 

          (j)  When the label or labeling of a bottled water product states or implies through label statements or vignettes that the bottled water is for use in feeding infants, and the product does not meet the definition of “sterile water” in He-P 2101.01(ae), the product label shall bear the statement “not sterile” conspicuously and on the principal display panel.

 

          (k)  Bottled water which has on its principal display panel, or primary label, a statement of identity such as spring water, purified water, or drinking water and contains added ingredients, including minerals, caffeine, flavorings, or any other additional ingredients, shall be clearly labeled as containing additional ingredients.

 

Source.  #12680, eff 11-27-18 (formerly He-P 2104.01)

 

          He-P 2103.14  Name of Product.

 

          (a)  The term “natural” may be used on the label with mineral, spring, artesian, or well water provided that the particular product also meets the definition of natural water in He-P 2101.01(r).

 

          (b)  All bottled water labeling shall comply with the standard of identity of the water source as defined in 21 CFR 165.110, He-P 2101, and as follows:

 

(1)  Artesian water as defined in He-P 2101.01(c) shall be labeled “artesian water” or “artesian well water”;

 

(2)  Deionized water as defined in He-P 2101.01(k) shall be labeled as “deionized water” or “deionized drinking water”;

 

(3)  Demineralized water as defined in He-P 2101.01(l) shall be labeled as “demineralized water” or “demineralized drinking water”;

 

(4)  Distilled water as defined in He-P 2101.01(n) shall be labeled as “distilled water” or “distilled drinking water”;

 

(5)  Mineral water as defined in He-P 2101.01(p) shall be labeled “mineral water”;

 

(6)  Purified water as defined in He-P 2101.01(z) shall be labeled “purified water” or “purified drinking water”;

 

(7)  Spring water as defined in He-P 2101.01(ad) shall be labeled “spring water”;

 

(8)  Sterile water as defined in He-P 2101.01(ae) shall be labeled as “sterile water” or “sterile drinking water”; and

 

(9)  Well water as defined in He-P 2101.01(ai) shall be labeled as “well water”.

 

Source.  #12680, eff 11-27-18 (formerly He-P 2104.03)

 

PART He-P 2104  APPLICATION AND LICENSING OF IN-STATE BEVERAGE AND BOTTLED WATER FACILITIES

 

          He-P 2104.01  Initial License Application Requirements.

 

          (a)  All applicants for licensure under RSA 143:10 shall complete and submit to the department, Form ISB APP “Application for Beverage and Bottled Water License” (November2018 Edition), obtained from the department at https://www.dhhs.nh.gov/dphs/fp/beverage/license.htm, affirming and certifying the following:

 

“I certify that all information provided in or attached to this application is complete, accurate and up-to-date as of the date specified below. I further certify that there are no willful misrepresentations of the answers to questions herein, and that I have made no omissions with response to any of my answers to the questions presented. I understand that it is my responsibility to immediately notify the Food Protection Section with regard to any changes, corrections or updates to the information provided.”

 

          (b)  The applicant shall include the following in the application submittal:

 

(1)  Copies of all types of labels to be used in New Hampshire;

 

(2)  Copies of any FDA approval issued relative to labels making claims of medicinal or health giving properties;

 

(3)  Laboratory results of the water analysis required by He-P2102, with the exception of He-P 2102.05 (b) (1) for both the source and the finished product, if the product is bottled water, or source water analysis if the product is a beverage; and

 

(4)  Cash, check, money order, or on-line payment for the applicable fees, in accordance with He-P 2104.04.

 

Source.  #1685, eff 12-21-80; 1930, eff 1-26-82; 2638(E), eff 3-2-84; #3000, eff 4-2-85; #3069, eff 7-23-85; ss by #4658, eff 7-31-89, EXPIRED: 7-31-95

 

New.  #7979, eff 10-22-03; ss by #10012, INTERIM, eff10-22-11, EXPIRES: 4-19-12; ss by #10116, eff 4-19-12, ss by #12680, eff 11-27-18 (formerly He-P 2106.01)

 

          He-P 2104.02  Processing of Initial Applications and Issuance of Licenses.

 

          (a)  An application shall be processed in accordance with RSA 541-A:29.

 

          (b)  An application for an initial license shall be complete when the department determines that all items required by He-P 2104.01 have been received.

 

          (c)  If an application does not contain all of the items required by He-P 2104.01, the department shall:

 

(1)  Not process that application; and

 

(2)  Notify the applicant in writing of which items are required to be submitted before the application can be processed.

 

          (d)  Any licensing fee submitted to the department in the form of a cash, check, money order, or online payment and returned to the state for any reason shall be processed in accordance with RSA 6:11-a.

 

          (e)  Licensing fees shall not be transferable to any other application(s).

 

          (f)  Following an inspection, conducted pursuant to RSA 143:11 and in accordance with He-P 2105, a provisional license shall be issued if the department determines that an applicant is in compliance with RSA 143,and these rules.

 

          (g)  Pursuant to RSA 143:11:

 

(1)  A provisional license shall expire 90 days after the date of issuance; and

 

(2)  If a license is not issued following the expiration of a provisional license, the beverage or bottled water facility shall cease operation the day after the provisional license expires and not operate until a license is obtained.

 

          (h)  All licenses and provisional licenses issued in accordance with RSA 143-A shall be issued for a specific license classification under He-P 2104.04.

 

          (i)  License holders shall operate in accordance with the class of license issued.

 

          (j)  Laboratory analysis of the source water, as required in He-P 2102.06, shall show the source water to be in compliance with the standards set forth in He-P 2102.02, provided the plant is bottling water.

 

          (k)  The labels shall be in compliance with He-P 2103.

 

          (l)  An inspection of the facility while in operation shall be conducted by the department within the 90 days that the provisional license is in effect.

 

          (m)  If the operational inspection and the analysis results of the finished product determine that the facility is in compliance with He-P 2100, a full annual license shall be issued.

 

Source.  #1685, eff 12-21-80; 1930, eff 1-26-82; 2638(E), eff 3-2-84; #3000, eff 4-2-85; #3069, eff 7-23-85; ss by #4658, eff 7-31-89, EXPIRED: 7-31-95

 

New.  #7979, eff 10-22-03; ss by #10012, INTERIM, eff10-22-11, EXPIRES: 4-19-12; ss by #10116, eff 4-19-12; ss by #12680, eff 11-27-18 (formerly He-P 2106.02)

 

          He-P 2104.03  License Expirations and Procedures for License Renewal.

 

          (a)  Licenses issued following a provisional license shall expire on the first day of January of the year following issuance unless revoked prior to that date.

 

          (b)  Each licensee shall apply to renew his or her license at least 30 days prior to the expiration of the current license.

 

          (c)  The licensee shall submit all requirements listed in 2104.01 (b) and any changes to information provided to the department in the initial application.

 

          (d)  A license shall be renewed if the department determines that the licensee:

 

(1) Submitted the renewal information containing all the items required by (c) above, as applicable, at least 30 days prior to the expiration of the current license;

 

(2) Has submitted a compliance agreement that has been accepted by the department and implemented by the licensee if the deficiencies were cited at the last licensing inspection; and

 

(3)  Is found to be in compliance with RSA 143 and He-P 2100.

 

          (e)  If a license holder fails to submit all required information and documentation  required for the renewal process as required under (b) and (c) above, the facility shall cease operation  the day after the license expires , and shall not operate until a license is obtained.

 

          (f)  License renewal applications shall be processed and issued or denied in accordance with He-P 2104.02 and 2106.04.

 

Source.  #1685, eff 12-21-80; 1930, eff 1-26-82; 2638(E), eff 3-2-84; #3000, eff 4-2-85; #3069, eff 7-23-85; ss by #4658, eff 7-31-89, EXPIRED: 7-31-95

 

New.  #7979, eff 10-22-03; ss by #10012, INTERIM, eff10-22-11, EXPIRES: 4-19-12; ss by #10116, eff 4-19-12; ss by #12680, eff 11-27-18

 

          He-P 2104.04  Beverage License Classes and In State Beverage Fees.

 

          (a)  Licensure fees shall be non-refundable and graduated by class in accordance with the following schedule:

 

(1)  “Class 1” means bottlers of 5,000 gallons or more per day, averaged over a period of one years. Bottlers in class 1 shall pay a licensure fee of $300;

 

(2) “Class 2” means bottlers of 500 gallons or more but less than 5000 gallons per day, averaged over a period of one year. Bottlers in class 2 shall pay a licensure fee of $175; and

 

(3)  “Class 3” means bottlers of less than 500 gallons per day, averaged over a one year period. Bottlers in class 3 shall pay a licensure fee of $75;

 

        (b)  Fees shall be due and payable prior to the issuance of a license.

 

Source.  #12680, eff 11-27-18

 

        He-P 2104.05  Change in Ownership of a Beverage or Bottled Water Facility.

 

        (a)  When there is a change of ownership of a bottled water or beverage facility, the new owner shall submit the items required for initial license applicants under He-P 2104.01 to the department at least 30 days prior to the change of ownership.

 

(b)  Upon receipt and processing of the items required by (a) above, and after an inspection conducted in accordance with He-P 2105.01 which shall also determine compliance with the beverage rules He-P 2100, the department shall issue a provisional license reflecting the change in ownership.

 

          (c)  The issuance of a provisional license due to a change in ownership shall void the license of the previous owner on the date the change of ownership occurs.

 

Source.  #12680, eff 11-27-18

 

          He-P 2104.06  Change in Name of a Beverage or Bottled Water Facility.

 

          (a)  When a license holder intends to change the name of a bottled water or beverage facility, that license holder shall submit a written request to the department for a new license at least 30 days prior to the intended date of change in name.

 

          (b)  The written request shall include:

 

(1)  The reason for requesting a new license;

 

(2)  The name of the bottled water or beverage facility as it appears on the existing license;

 

(3)  The name of the bottled water or beverage facility as the license holder requests it to appear on the new license; and

 

(4)  The date upon which the change in name is intended to occur.

 

           (c)  Following receipt of the items required by (b) above, the commissioner shall issue a revised license reflecting the change in name.  The establishment number and expiration date shall remain the same as it was on the immediately preceding license.

 

Source.  #12680, eff 11-27-18

 

          He-P 2104.07  Change in Location of a Bottled Water or Beverage Facility.

 

          (a)  When there is a change of location of a bottled water or beverage facility, the license holder shall submit the items required for initial license applicants under He-P 2104.01 to the department at least 30 days prior to the change of location.

 

          (b)  Upon receipt and processing of the items required under (a) above, and after an inspection conducted in accordance with He-P 2105.01 , the department shall issue a provisional license reflecting the change of location.

 

          (c)  The issuance of a provisional license due to a change in location shall void the previous license on the date the change of location occurs.

 

Source.  #12680, eff 11-27-18

 

          He-P 2104.08  Change in License Class.

 

          (a)  A license holder wishing to request an upgrade to a higher-level class of license listed in He-P 2104.04 shall:

 

(1)  Be treated as an applicant for a new license; and

 

(2)  Apply for a new license in accordance with He-P 2104.01.

 

          (b)  The issuance of a provisional license due to an upgrade in license class shall void the previous license on the date the upgrade occurs.

 

          (c)  A license holder wishing to request a downgrade to a lower level class of license listed in He-P 2104.04 shall submit a written request for downgrade to the department.

 

          (d)  The written request in (c) above shall include:

 

(1)  The reason for requesting a downgrade; and

 

(2)  The date upon which the downgrade is intended to occur.

 

          (e)  Following receipt of the request under (c) above, the licensee shall be issued a revised license reflecting the downgrade in class of license.  The establishment number and expiration date shall remain the same as it was on the immediately preceding license.

 

Source.  #12680, eff 11-27-18

 

          He-P 2104.09  Submission of Plans and Specifications for New or Remodeled Beverage Facilities.

 

          (a)  A new applicant or a current license holder undergoing remodeling of a beverage facility shall complete and submit to the department Form BBFPAPP “Plan Review Application”(October 2018 Edition).

 

          (b)  In addition to submitting a completed application in (a) above, an applicant or license holder shall provide  with the application a copy of the plans and specifications for the beverage facility that include:

 

(1)  Location of all equipment which clearly identifies the piece of equipment;

 

(2)  Location of all refrigeration;

 

(3)  Location of all sinks; and

 

(4)  Location of all restrooms, employee locker, and lunch rooms.

 

          (c)  The application and attachments in (a) and (b) above shall be submitted at least 45 days prior to:

 

(1)  Constructing a new beverage facility;

 

(2)  Remodeling  an existing structure for use as a beverage facility;

 

(3)  Remodeling a beverage facility; or

 

(4)  Relocating a beverage facility when the relocation also involves (1), (2), or (3) above.

 

          (d)  An applicant or licensee shall pay a fee of $75, in the form of cash, check, money order or online payment, submitted with the application, for each plan review application submitted.

 

          (e)  The department shall review plans for construction, remodeling  or structural alterations of a beverage facility for compliance with all applicable sections of RSA 143 and He-P 2100 and notify the applicant or licensee as to whether the plan complies with the requirements set forth therein.

 

Source.  #12680, eff 11-27-18

 

          He-P 2104.10  Variances.

 

          (a)  Applicants or license holders seeking variances from specific rules shall contact the department by telephone at (603) 271-4589 or by mail, to obtain a VR Form “Beverage and Bottled Water License Variance Request Form” (October 2018 Edition).

 

          (b)  Applicants or license holders shall complete and submit VR Form “Beverage and Bottled Water License Variance Request Form” (October 2018 Edition) to the department by mailing to:

 

Department of Health and Human Services

Division of Public Health Services

Food Protection Section

29 Hazen Dr.

Concord, NH 03301

 

          (c)  The commissioner shall approve a request for variance if:

 

(1)  The commissioner concludes that authorizing deviation from strict compliance with the rule item from which a variance is sought does not contradict the intent of the rule; and

 

(2)  The alternative proposed by the applicant or license holder ensures that the objective or intent of the rule item from which a variance is sought will be accomplished.

 

          (d)  If a variance is approved, the license holder’s subsequent compliance with the alternatives approved in the variance shall be considered equivalent to complying with the rule item from which a variance was sought.

 

          (e)  A variance shall be approved until the expiration of the current license or as specified by the department.

 

          (f)  No request for a variance concerning the rules of other state agencies which are referred to in this chapter shall be approved.

 

Source.  #12680, eff 11-27-18

 

PART He-P 2105  INSPECTIONS AND COMPLIANCE

 

          He-P 2105.01   Inspection of Beverage Facilities.

 

          (a)  Inspections shall be conducted:

 

(1)  Prior to issuance of a license;

 

(2)  At least once annually; or

 

(3)  Whenever the department has reason to believe a condition exists that places the bottling facility in non-compliance with RSA 143 and He-P 2100.

 

          (b)  Inspections shall be scored by a point system with the following points being assigned to each item:

 

(1)  Floors, walls, ceilings, 2 points;

 

(2)  Outer openings and doors, 2 points;

 

(3)  Lighting and ventilation, 2 points;

 

(4)  Plumbing, constructed and installed, 4 points;

 

(5)  Plumbing in good repair, 2 points;

 

(6)  Sewage disposal, 4 points;

 

(7)  Handwash stations, 2 points;

 

(8)  Restrooms, 2 points;

 

(9)  Separate rooms, 2 points;

 

(10)  Plant cleanliness, 2 points

 

(11)  Evidence of insects or rodents, 2 points;

 

(12)  Well head maintenance and construction, 2 points;

 

(13)  Equipment properly, designed and stored, 2 points;

 

(14)  Proper tank ventilation, 2 points;

 

(15)  Contact surfaces cleaned, 4 points;

 

(16)  Contact surfaces sanitized, 4 points;

 

(17)  Preventing contamination, 2 points;

 

(18)  Facilities for storage, 2 points;

 

(19)  Facilities for transfer, 2 points;

 

(20)  Shipping statements, 2 points

 

(21)  Filling access points and seals, 2 points;

 

(22)  Process review on site, 2 points;

 

(23)  Process review followed, 4 points;

 

(24)  Records maintained and properly retained, 2 points

 

(25)  Approved treatment, 4 points;

 

(26)  Container integrity, 2 points;

 

(27)  Performance of filler, capper and sealer monitored, 2 points;

 

(28)  Air under pressure cleaned and filled, 2 points;

 

(29)  Operation conducted to preclude the contamination of product, 2 points;

 

(30)  Container and cap storage, 2 points;

 

(31)  Product properly labeled, 2 points;

 

(32)  Date coding, 2 points;

 

(33)  Source water testing, 4 points;

 

(34)  Finished product testing, 4 points;

 

(35)  Recall procedure developed, 4 points;

 

(36)  Sanitizing log, 2 points;

 

(37)  Records maintained and properly retained, 2 points;

 

(38)  Health and reporting, 4 points;

 

(39)  Personal cleanliness, 2 points; and

 

(40)  Proper handwashing, 4 points.

 

          (c)  The license holder shall be notified in writing of violations and the compliance status of the facility.

 

          (d)  Follow-up inspections shall be conducted on noncompliant facilities.

 

          (e)  If a second follow-up inspection determines the facility is still non-compliant, the licensee shall enter into a compliance agreement in accordance with He-P 2105.02

 

Source.  #1685, eff 12-21-80; 1930, eff 1-26-82; 2638(E), eff 3-2-84; #3000, eff 4-2-85; #3069, eff 7-23-85; ss by #4658, eff 7-31-89, EXPIRED: 7-31-95

 

New.  #7979, eff 10-22-03; ss by #10012, INTERIM, eff 10-22-11, EXPIRES: 4-19-12; ss by #10116, eff 4-19-12; ss by #12680, eff 11-27-18

 

          He-P 2105.02  Compliance Agreements.

 

          (a)  Compliance agreements shall be completed at the conclusion of an inspection or at a mutually agreed upon time and place between the license and inspector, with in a time period not to exceed one week. 

 

          (b)  The following shall be provided in the compliance agreement:

 

(1)  The date of the agreement;

 

(2)  The name of the establishment;

 

(3)  The license number of the establishment;

 

(4)  The name of the person in charge of the establishment;

 

(5)  Attestation to the agreement to make repairs, corrections or changes that are necessary to bring the establishment into compliance with He-P 2100;

 

(6) A list of each repair, correction, or change to be made including the date of intended completion;

 

(7)  The signature of the person in charge;

 

(8)  The title of the signee; and

 

(9)  The signature of the inspector or department representative making the agreement.

 

          (c)  Failure on the part of the license holder to comply with the signed compliance agreement shall result in action against the license as specified in He-P 2105.01(e) and He-P 2106.02.

 

Source.  #1685, eff 12-21-80; 1930, eff 1-26-82; 2638(E), eff 3-2-84; #3000, eff 4-2-85; #3069, eff 7-23-85; ss by #4658, eff 7-31-89, EXPIRED: 7-31-95

 

New.  #7979, eff 10-22-03; ss by #10012, INTERIM, eff 10-22-11, EXPIRES: 4-19-12; ss by #10116, eff 4-19-12; ss by #12680, eff 11-27-18 

 

PART He-P 2106  ENFORCEMENT ACTIONS

 

                 He-P 2106.01  Enforcement Actions and Notice of Right to Appeal.

 

          (a)  The department shall impose enforcement actions for violations of RSA 143, or He-P 2100, including the following:

 

(1)  Imposing fines upon an applicant, licensee, or unlicensed individual;

 

(2)  Denying a license application;

 

(3)  Revoking a license; or

 

(4)  Immediately closing the beverage facility.

 

          (b)  When imposing a fine, denying a license application, or revoking a license, the department shall send to the applicant or licensee a written notice that sets forth:

 

(1)  The action to be taken by the department;

 

(2)  The reasons for the action, including the identification of each deficiency as applicable; and

 

(3)  The right of the applicant or licensee to request a hearing in accordance with RSA 541-A, He-C 200, and He-P 2106 prior to the enforcement action becoming final.

 

          (c)  No ongoing enforcement action shall preclude the imposition of any remedy available to the department under RSA 143, RSA 541-A:30, III, or He-P 2100.

 

Source.  #1685, eff 12-21-80; 1930, eff 1-26-82; 2638(E), eff 3-2-84; #3000, eff 4-2-85; #3069, eff 7-23-85; ss by #4658, eff 7-31-89, EXPIRED: 7-31-95

 

New.  #7979, eff 10-22-03; ss by #10012, INTERIM, eff 10-22-11, EXPIRES: 4-19-12; ss by #10116, eff 4-19-12; ss by #12680, eff 11-27-18

 

          He-P 2106.02  Schedule of Administrative Fines.  The department shall impose administrative fines not to exceed the specified amounts for the following violations:

 

          (a)  For willful submission of fraudulent or materially false information on or with an application, in violation of He-P 2104.01 or He-P 2107.01, the fine shall be $1,000;

 

          (b)  For failure to cooperate during an inspection of a beverage or water bottling facility, the fine shall be $2,000;

 

          (c)  For operating a beverage or water bottling facility in the state without first obtaining a license, as required in RSA 143:10, the fine shall be $1,000.  Each day that an individual or business continues to operate without obtaining a license shall be considered a separate offense subject to an additional $500 fine;

 

          (d)  For failure to cease operation upon notification by the department to do so, the fine shall be $1,000. Each day that a license holder fails to cease operation shall be considered a separate offense subject to an additional $500 fine;

 

          (e)  For failure to cease operation after a license has expired when an application has been denied or when a license has been revoked, the fine shall be $1,000. Each day that a license holder fails to cease operation shall be considered a separate offense subject to an additional $500 fine;

 

          (f)  For failure to notify the department within 24 hours of receiving an analysis result indicating that a quality standard as set forth in He-P 2102.02 has been exceeded or identifying other circumstances that might adversely affect the safety of the bottled product as required in He-P 2103.08 (e) and He-P 2102.07 the fine shall be $100;

 

          (g)  For failure to obtain a registration before offering for sale within the state any beverage or bottled water which is bottled outside New Hampshire, the fine shall be $500. Each day the beverage or bottled water is offered for sale in New Hampshire shall be considered a separate offense subject to an additional $250 fine;

 

          (h)  For failure to remove a product from commerce in New Hampshire when a registration has been revoked, the fine shall be $1,000. Each day the beverage or bottled water is offered for sale after revocation shall be considered a separate offense subject to an additional $500 fine;

 

          (i)  For failure to submit a timely license renewal application in accordance with He-P 2104.03 (c), the fine shall be $75;

 

          (j)  For failure to submit a timely registration renewal application in accordance with He-P 2104.03, the fine shall be $75;

 

          (k)  For failure to notify the department by telephone within 24 hours of any fire or other disaster that jeopardizes the safety or sanitation of bottled product in a bottled beverage establishment establishments, in violation of He-P 2106.06(a), the fine shall be $250;

 

          (l)  For failure to notify the department pursuant to He-P 2104.05(a) at least 30 days prior to a beverage facility ownership change, the fine shall be $500;

 

          (m)  For failure to notify the department pursuant to He-P 2104.07(a) at least 30 days prior to the change of location of a beverage facility, the fine shall be $500;

 

          (n)  For failure to submit a plan for review as required in He-P 2104.09(a) and (b), the fine shall be $300;

 

          (o)  For failure to cease operation upon notification by the department to do so, the fine shall be $1,000.  Each day that a license holder fails to cease operation shall be considered a separate offense subject to an additional $500 fine;

 

          (p)  For failure to cease operation after a license has expired, when an application has been denied, or when a license has been revoked, the fine shall be $1,000.  Each day that a license holder fails to cease operation shall be considered a separate offense subject to an additional $500 fine;

 

          (q)  For failure to pay an administrative fine within 30 days of its imposition, or within 30 days of the decision to uphold the imposition of a fine that was appealed, the fine shall be $500. Each day until the expiration of the current license, that a license holder fails to pay such a fine shall be considered a separate offense subject to an additional $500 fine;

 

          (r)  For a failure to comply with any compliance agreement that has been accepted by the department, the fine shall be $500;

 

          (s)  For violating a variance approved in accordance with He-P 2104.10, the fine shall be $500; and

 

          (t)  For failure to enter into a compliance agreement, when required by He-P 2105.02, the fine shall be $500.

 

Source.  #1685, eff 12-21-80; 1930, eff 1-26-82; 2638(E), eff 3-2-84; #3000, eff 4-2-85; #3069, eff 7-23-85; ss by #4658, eff 7-31-89, EXPIRED: 7-31-95

 

New. #7979, eff 10-22-03; ss by #10012, INTERIM, eff 10-22-11, EXPIRES: 4-19-12; ss by #10116, eff 4-19-12; ss by #12680, eff 11-27-18

 

          He-P 2106.03  Form of Payment of Fees and Administrative Fines.  Whenever an applicant or license or registration holder makes a payment to the department in satisfaction of a fee or administrative fine, the following shall apply:

 

          (a)  Payment shall be made in the form of cash, check or money order for the exact amount due;

 

          (b)  Cash, money order or certified check shall be required when an applicant or license or registration holder has issued payment to the department by check, and such check was returned for insufficient funds;

 

          (c)  Any instrument described in (a) or (b) above shall be made payable to the “Treasurer–State of New Hampshire”; and

 

          (d)  Any payment made to the department by check which is returned for insufficient funds, and which an applicant or license or registration holder has not made good by submitting cash, money order or certified check within 2 business days of notification by the department, including any penalty assessment required by RSA 6:11-a, shall result in denial of the application or revocation of the license or registration after notice and opportunity for a hearing.

 

Source.  #1685, eff 12-21-80; 1930, eff 1-26-82; 2638(E), eff 3-2-84; #3000, eff 4-2-85; #3069, eff 7-23-85; ss by #4658, eff 7-31-89, EXPIRED: 7-31-95

 

New.  #7979, eff 10-22-03; ss by #10012, INTERIM, eff 10-22-11, EXPIRES: 4-19-12; ss by #10116, eff 4-19-12; ss by #12680, eff 11-27-18

 

          He-P 2106.04  Denial or Revocation of License.

 

          (a)  The department shall deny an application or revoke a license if:

 

(1)  Inspection of the facility indicates that conditions or operations are such that contamination of the beverages or water is occurring or might occur which might cause a threat to the public health and safety and steps are not taken immediately to bring the conditions or operations into compliance;

 

(2)  An applicant or licensee has failed to pay any applicable fee in accordance with He-P 2104.04 or any administrative fine imposed under He-P 2106.02 or any other court authorized sanction or fee;

 

(3)  An applicant or a licensee has had a check returned to the department for insufficient funds and has not re-submitted the outstanding fee and additional charges in the form of money order or certified check within 2 business days of notification by the department;

 

(4)  After being notified of and given an opportunity to supply missing information, an applicant or licensee fails to submit an application that meets the requirements of He-P 2104.01(b);

 

(5)  An applicant, licensee or any representative or employee of the applicant or licensee:

 

a.  Provides false or misleading information to the department;

 

b.  Prevents or interferes, or fails to cooperate with any inspection or investigation conducted by the department; or

 

c.  Fails to provide, upon request, information or documents to the department;

 

(6)  There is a deficiency identified in the inspection report and the applicant or licensee does not either correct it or complete a compliance agreement in accordance with He-P 2105.02;

 

(7)  The licensee fails to implement or continue to implement a compliance agreement that has been accepted by the department in accordance with He-P 2105.02;

 

(8)  The licensee fails, without prior notification to the department, to attend a compliance meeting; or

 

(9)  The licensee is bottling water and analysis of the source or finished product water indicates one or more parameters of public health significance exceed the quality standards set forth in He-P 2102.02 and immediate steps are not taken to remove the contaminants.

 

          (b)  The department shall revoke a license in accordance with RSA 143:14 and RSA 541-A:30, II.

 

          (c)  Hearings and appeals of decisions of the department resulting from an adjudicative proceeding shall be in accordance with He-C 200.

 

Source.  #1685, eff 12-21-80; 1930, eff 1-26-82; 2638(E), eff 3-2-84; #3000, eff 4-2-85; #3069, eff 7-23-85; ss by #4658, eff 7-31-89, EXPIRED: 7-31-95

 

New.  #7979, eff 10-22-03; ss by #10012, INTERIM, eff 10-22-11, EXPIRES: 4-19-12; ss by #10116, eff 4-19-12; ss by #12680, eff 11-27-18

 

          He-P 2106.05  Effect of Denial of Application or Revocation.

 

          (a)  Any applicant who has been denied a license or renewal license shall not operate or shall cease operation of the beverage facility for which the license or renewal license was denied within 10 calendar days after receipt of the denial notice, unless a timely appeal is submitted.

 

          (b)  If a license is revoked by the department, the beverage facility shall cease operation of the beverage production within 10 calendar days after receipt of the revocation notice, unless a timely appeal is submitted.

 

          (c)  If a beverage facility is subject to immediate closure as defined in RSA 143:13, the beverage facility shall immediately cease operation pending reinspection and pursuant to the adjudicative proceedings provisions of RSA 541-A.

 

          (d)  If a license expires without a timely application for renewal having been made, the beverage facility shall immediately cease operation of the beverage production.

 

Source.  #1685, eff 12-21-80; 1930, eff 1-26-82; 2638(E), eff 3-2-84; #3000, eff 4-2-85; #3069, eff 7-23-85; ss by #4658, eff 7-31-89, EXPIRED: 7-31-95

 

New.  #7979, eff 10-22-03; ss by #10012, INTERIM, eff 10-22-11, EXPIRES: 4-19-12; ss by #10116, eff 4-19-12; ss by #12680, eff 11-27-18 (formerly He-P 2107.06)

 

          He-P 2106.06  Closures.

 

          (a)  A licensee shall immediately discontinue operations and notify the department at 603-271-4589, or if at night or during weekends at 603-271-5300, if an imminent health hazard might exist because of an emergency such as:

 

(1)  A failed sewer system or a sewage backup into the beverage or bottled water facility;

 

(2)  A fire affecting a beverage or bottled water facility;

 

(3)  Flooding in a beverage or bottled water facility;

 

(4)  Chemical exposure in a beverage or bottled water facility;

 

(5)  Any other natural disaster or catastrophic event that could result in contamination of the beverage or bottled water; and

 

(6)  Any other severe unsanitary conditions that threaten to contaminate the beverage or bottled water or its ingredient supply.

 

          (b)  A licensee shall not be required to discontinue operations in an area of the beverage or bottled water facility that is unaffected by the imminent health hazard.

 

          (c)  If operations are discontinued as specified in (a) above, the licensee shall obtain approval from the department before resuming operations.

 

          (d)  The department shall approve the resumption of operations if the imminent health hazard no longer exists or the licensee has offered a plan to mitigate all threats to health or safety.

 

          (e)  The failure to include other violations, practices, circumstances, or events in this section shall not be construed as a determination that other violations, practices, circumstances, or events are not or shall not be considered an imminent health hazard.

 

          (f)  The commissioner’s order of an immediate closure of a beverage or bottled water facility shall be in accordance with the provisions of RSA 143:13.

 

Source.  #1685, eff 12-21-80; 1930, eff 1-26-82; 2638(E), eff 3-2-84; #3000, eff 4-2-85; #3069, eff 7-23-85; ss by #4658, eff 7-31-89, EXPIRED: 7-31-95

 

New.  #7979, eff 10-22-03; ss by #10012, INTERIM, eff 10-22-11, EXPIRES: 4-19-12; ss by #10116, eff 4-19-12; ss by #12680, eff 11-27-18 (formerly He-P 2155.06)

 

PART He-P 2107  REGISTRATION OF OUT-OF-STATE BEVERAGES AND BOTTLED WATER

 

          He-P 2107.01  Submission of Initial Registration Applications.

 

             (a)  All applicants registering their products in accordance with RSA 143:12 shall complete and submit to the department Form OSB APP “Application for Beverage and Bottled Water Registration” (October 2018 Edition), obtained from the department or available at https://www.dhhs.nh.gov/dphs/fp/beverage/license.htm, affirming and certifying the following:

 

“I certify that all information provided in or attached to this application is complete, accurate and up-to-date as of the date specified below. I further certify that there are no willful misrepresentations of the answers to questions herein, and that I have made no omissions with respect to any of my answers to the questions presented. I understand that it is my responsibility to immediately notify the Food Protection Section with regard to any changes, corrections or updates to the information provided.

 

          (b)  The applicant shall include the following information in the application submittal:

 

(1)  A copy of a sanitary inspection conducted within the previous 12 months by the regulatory authority with jurisdiction or a recognized national third party audit organization, a letter from the regulatory authority confirming compliance with local regulations or a health certificate for the bottling facility issued within the previous 12 months; and

 

(2)  If the product is bottled water, a copy of the approval of the source for bottled water, including the approval for the designation “spring water”, if the product is labeled as such, issued by the federal, state, local, provincial or other government agency with the authority to approve sources for bottled water.

 

          (c)  Cash, check, money order, or online payment for the application fee of $400, in accordance with RSA 143:12 shall be submitted with the registration application.

 

          (d)  Upon receipt of an application for registration and appropriate registration fee, the commissioner shall approve or deny the application in accordance with He-P 2107.04.

 

Source.  #1685, eff 12-21-80; 1930, eff 1-26-82; 2638(E), eff 3-2-84; #3000, eff 4-2-85; #3069, eff 7-23-85; ss by #4658, eff 7-31-89, EXPIRED: 7-31-95

 

New.  #7979, eff 10-22-03; ss by #9589, eff 11-5-09; amd by #10956, eff 10-22-15, paras (a), (b), (d), and (e) EXPIRED: 11-5-17; ss by #12680, eff 11-27-18

 

     He-P 2107.02  Processing of Out of State Registration Applications.

 

          (a)  An application shall be processed in accordance with RSA 541-A:29.

 

          (b)  If the application does not contain all of the items required by He-P 2107.01, the department shall:

 

(1)  Not process that application; and

 

(2)  Notify the applicant in writing that all required items must be submitted within 30 days in order for the application to be processed.

 

          (c)  If all the items required by He-P 2107.01 are received, the application shall be deemed to be complete.

 

Source.  #1685, eff 12-21-80; 1930, eff 1-26-82; 2638(E), eff 3-2-84; #3000, eff 4-2-85; #3069, eff 7-23-85; ss by #4658, eff 7-31-89, EXPIRED: 7-31-95

 

New.  #7979, eff 10-22-03; ss by #10012, INTERIM, eff 10-22-11, EXPIRES: 4-19-12; ss by #10116, eff 4-19-12; ss by #12680, eff 11-27-18

 

          He-P 2107.03  Registration Issuance and Duration.

 

          (a)  A registration shall be issued if the following are met:

 

(1)  The application meets the requirements of He-P 2107.01; and

 

(2)  The inspection report or health certificate submitted with the application indicates that the bottling facility meets the equivalent requirements of He-P 2100.

 

          (b)  All registrations shall remain in effect until the first day of January of the year following issuance unless revoked prior to that date.

 

          (c)  Registrations shall not be transferable with respect to persons or locations.

 

          (d)  Information required with the registration application, including water sources, product labels or FDA labeling approvals, which changes before the registration expires shall be submitted to the department for review at the time the change is made.

 

Source.  #1685, eff 12-21-80; 1930, eff 1-26-82; 2638(E), eff 3-2-84; #3000, eff 4-2-85; #3069, eff 7-23-85; ss by #4658, eff 7-31-89, EXPIRED: 7-31-95

 

New.  #7979, eff 10-22-03; ss by #10012, INTERIM, eff 10-22-11, EXPIRES: 4-19-12; ss by #10116, eff 4-19-12; ss by #12680, eff 11-27-18

 

     He-P 2107.04 Denial of Registration Applications. The department shall deny a registration application when:

 

          (a)  The application submitted is incomplete and the information requested in accordance with He-P 2107.01 is not provided; or

 

          (b)  The inspection of the facility submitted with the application shows noncompliance with He-P 2100.

 

Source.  #1685, eff 12-21-80; 1930, eff 1-26-82; 2638(E), eff 3-2-84; #3000, eff 4-2-85; #3069, eff 7-23-85; ss by #4658, eff 7-31-89, EXPIRED: 7-31-95

 

New.  #7979, eff 10-22-03; ss by #10012, INTERIM, eff 10-22-11, EXPIRES: 4-19-12; ss by #10116, eff 4-19-12; ss by #12680, eff 11-27-18

 

          He-P 2107.05  Revocation of Registrations.

 

          (a)  The department shall revoke a registration if the department has reason to believe that the beverage or bottled water being sold in the State of New Hampshire represents a threat to the public health and safety and there is no effort to correct the situation on behalf of the regulatory authority with control over the bottling facility.

 

          (b)  The department shall revoke a registration in accordance with the procedures set forth in RSA 143:14 and RSA 541-A:30, II.

 

          (c)  Hearings and appeals of decisions of the department, resulting from an adjudicative proceeding shall be in accordance with He-C 200.

 

Source.  #1685, eff 12-21-80; 1930, eff 1-26-82; 2638(E), eff 3-2-84; #3000, eff 4-2-85; #3069, eff 7-23-85; ss by #4658, eff 7-31-89, EXPIRED: 7-31-95

 

New.  #7979, eff 10-22-03; ss by #10012, INTERIM, eff 10-22-11, EXPIRES: 4-19-12; ss by #10116, eff 4-19-12; ss by #12680, eff 11-27-18

 

          He-P 2107.06  Effect of Denial of Application or Revocation.

 

          (a)  Any applicant who has been denied a registration shall not sell beverages or bottled water in the State of New Hampshire.

 

          (b)  If a registration has been revoked, the registrant shall immediately remove all product from commerce in the State of New Hampshire.

 

Source.  #1685, eff 12-21-80; 1930, eff 1-26-82; 2638(E), eff 3-2-84; #3000, eff 4-2-85; #3069, eff 7-23-85; ss by #4658, eff 7-31-89, EXPIRED: 7-31-95

 

New.  #7979, eff 10-22-03; ss by #10012, INTERIM, eff 10-22-11, EXPIRES: 4-19-12; ss by #10116, eff 4-19-12; ss by #12680, eff 11-27-18

 

          He-P 2107.07  Renewal of Registrations.

 

          (a)  A request to renew the registration shall be made to the department at least 30 days prior to the expiration of the registration.

 

          (b)  To renew, an applicant shall supply the requirements with supporting documentation required in He-P 2107.01, any changes to information provided to the department on the initial application, and payment as specified in He-P 2701.01(c), except the description of the source shall not need to be resubmitted unless the source has changed.

 

          (c)  Registration renewals shall be processed and issued or denied in accordance with He-P 2107.02, He-P 2107.03, and He-P 2107.04.

 

Source.  #1685, eff 12-21-80; 1930, eff 1-26-82; 2638(E), eff 3-2-84; #3000, eff 4-2-85; #3069, eff 7-23-85; ss by #4658, eff 7-31-89, EXPIRED: 7-31-95

 

New.  #7979, eff 10-22-03; ss by #10012, INTERIM, eff 10-22-11, EXPIRES: 4-19-12; ss by #10116, eff 4-19-12; ss by #10956, eff 10-22-15; ss by #12680, eff 11-27-18

 

PART He-P 2108  ADMINISTRATIVE FINES – RESERVED

 

          He-P 2108.01  Procedure for Administrative Fines.  Reserved

 

Source.  #1685, eff 12-21-80; 1930, eff 1-26-82; 2638(E), eff 3-2-84; #3000, eff 4-2-85; #3069, eff 7-23-85; ss by #4658, eff 7-31-89, EXPIRED: 7-31-95

 

New.  #7979, eff 10-22-03; ss by #10012, INTERIM, eff 10-22-11, EXPIRES: 4-19-12; ss by #10116, eff 4-19-12; rpld by #12680, eff 11-27-18

 

          He-P 2108.02  Schedule of Administrative Fines.  Reserved

 

Source.  #1685, eff 12-21-80; 1930, eff 1-26-82; 2638(E), eff 3-2-84; #3000, eff 4-2-85; #3069, eff 7-23-85; ss by #4658, eff 7-31-89, EXPIRED: 7-31-95

 

New.  #7979, eff 10-22-03; ss by #9589, eff 11-05-09; ss by #10116, eff 4-19-12; ss by #10956, eff 10-22-15; rpld by #12680, eff 11-27-18

 

          He-P 2108.03  Form of Payment of Fees and Administrative Fines.  Reserved

 

Source.  #1685, eff 12-21-80; 1930, eff 1-26-82; 2638(E), eff 3-2-84; #3000, eff 4-2-85; #3069, eff 7-23-85; ss by #4658, eff 7-31-89, EXPIRED: 7-31-95

 

New.  #7979, eff 10-22-03; ss by #10012, INTERIM, eff 10-22-11, EXPIRES: 4-19-12; ss by #10116, eff 4-19-12; rpld by #12680, eff 11-27-18

 

PART He-P 2109 through He-P 2149 - RESERVED

 

PART He-P 2150 NEW HAMPSHIRE SHELLFISH SANITATION RULES: DECLARATION OF PURPOSE

 

Statutory Authority: RSA 143:20-28

 

REVISION NOTE:

 

            Document #10704, effective 10-23-14, readopted with amendments the former rules He-P 2150, titled “New Hampshire Shellfish Sanitation Rules”, and renumbered them as Part He-P 2150 through Part He-P 2159.  Document #10704 made extensive changes to the wording, numbering, and format of rules in the former He-P 2150.

 

            Document #10704 replaces all prior filings for rules in the former He-P 2150.  The filings affecting the former He-P 2150 include the following documents:

 

            #3069, eff 7-23-85, EXPIRED: 7-23-91

            #4229, eff 2-23-87

            #4658, eff 7-31-89, EXPIRED: 7-31-95

            #6587, eff 9-26-97

            #7653, eff 2-21-02

            #8899, eff 6-9-07

            #9589, eff 11-5-09

 

            The Part numbers for former Part He-P 2151 through former Part He-P 2159 had been reserved prior to the filing of Document # 10704 because the rules filed in those Parts had expired.  The filings affecting the former He-P 2151 through He-P 2159 had included the following documents:

 

          He-P 2151  Titled: “Sanitation of Shellfish Growing Areas – Laboratory Procedures

          #3069, eff 7-23-85

          #4229, eff 2-23-87

          #4658, eff 7-31-89, EXPIRED: 7-31-95

 

          He-P 2152  Titled “Sanitation of Shellfish Growing Areas – Growing Area Survey and Classification

          #3069, eff 7-23-85

          #4128, eff 9-10-86;

          #4229, eff 2-23-87

          #4658, eff 7-31-89, EXPIRED: 7-31-95

 

          He-P 2153  Titled: Sanitation of Shellfish Growing Areas – Preparation of Shellfish for Marketing

          #3069, eff 7-23-85

          #4229, eff 2-23-87

          #4658, eff 7-31-89, EXPIRED: 7-31-95

 

          He-P 2154  RESERVED

          #3069, eff 7-23-85

          #4229, eff 2-23-87

          #4658, eff 7-31-89, EXPIRED: 7-31-95

 

          He-P 2155 Titled: “Sanitation of Shellfish Growing Areas – Bacteriological Criteria for Shucked Oysters at the Wholesale Market Level

          #4229, eff 2-23-87

          #4658, eff 7-31-89, EXPIRED: 7-31-95

 

          He-P 2156 through 2159 RESERVED

          #3069, eff 7-23-85

          #4229, eff 2-23-87

          #4658, eff 7-31-89, EXPIRED: 7-31-95

 

He-P 2150.01  Declaration of Purpose.

 

(a)  RSA 143:20-28 requires the New Hampshire department of health and human services to ensure the safety of shellfish being sold for food within the State of New Hampshire.

 

(b)  RSA 143:26 enables the commissioner of the department of health and human services and the commissioner of the department of environmental services to make all necessary regulations for the proper enforcement of the respective duties of each agency.

 

(c)  The purpose of these rules is:

 

(1)  To ensure that shellfish being sold for food complies with the provisions of RSA 143:20-28;

 

(2)  To outline the procedures for the certification of persons, firms or corporations processing or packing shellfish either shucked or in the shell; and

 

(3)  To outline the procedures for the denial of an application for a shellfish certificate, suspension or revocation of any shellfish certificate, or other enforcement action.

 

Source.  (See Revision Note at part heading for He-P 2150) #10704, eff 10-23-14

 

PART He-P 2151  NEW HAMPSHIRE SHELLFISH SANITATION RULES:  DEFINITIONS

 

          He-P 2151.01  Definitions.

 

          (a)  “Adequately iced” means that the amount and application of the ice is sufficient to ensure that immediate cooling begins and continues for all shellfish.  If ice slurry is used and the shellfish are submerged, the presence of ice in the slurry indicates adequate ice.

 

          (b)  “Approved” means a classification used as an identifier for a growing area where harvest for direct marketing is allowed.

 

          (c)  “Aquaculture” means the cultivation of seed in natural or artificial growing areas, or the cultivation of shellstock other than seed in growing areas.

 

          (d)  “Authority” means the state or local shellfish control authority or authorities or their designated agents, which are responsible for the enforcement of the National Shellfish Sanitation Program (NSSP) Guide for the Control of Molluscan Shellfish, 2013 Revision, as incorporated by reference and amended in He-P 2152.01.

 

          (e)  “Back siphonage” means the flowing back of used, contaminated, or polluted water from a plumbing fixture, vessel, or other source into potable water supply pipes because of negative pressure in the water supply pipes.

 

          (f)  “Backflow” means the flow of water or other liquids, mixtures, or substances into the distribution pipes of a potable water supply from any source or sources other than the intended source.

 

          (g)  “Certificate” means the document issued by the authority to a person to harvest or transport shellstock for commercial sale.

 

          (h)  “Certification” means the issuance of a numbered certificate to a person for a particular activity or group of activities that indicates:

 

(1)  Permission from the department to conduct the activity; and

 

(2)  Compliance with the provisions of RSA 143:22 and the requirements of these rules including the NSSP Guide for the Control of Molluscan Shellfish, 2013 Revision, as incorporated by reference and amended in He-P 2152.01.

 

          (i)  “Certification number” means the unique identification number issued by the authority to each dealer for each location, which consists of a one to 5 digit Arabic number preceded by the 2 letter state abbreviation and followed by a 2 letter abbreviation for the type of activity or activities the dealer is qualified to perform in accordance with these rules and the NSSP Guide for the Control of Molluscan Shellfish, 2013 Revision, as incorporated by reference in He-P 2152.01, using the following terms:

 

(1)  Shellstock shipper (SS);

 

(2)  Shucker-packer (SP);

 

(3)  Repacker (RP);

 

(4)  Reshipper (RS); and

 

(5)  Depuration processor (DP).

 

          (j)  “Commingling” means the act of combining different lots of shellfish.

 

          (k)  “Commissioner” means the commissioner of the New Hampshire department of health and human services, or his or her designee.

 

          (l)  “Compliance schedule” means a written schedule that provides a correction time period to eliminate key and other deficiencies.

 

          (m)  “Conditional area management plan” means a plan developed by the NH department of environmental services (DES) which establishes a strict set of criteria to be met for the growing area to remain in the open status.

 

          (n)  “Conditionally approved” means a classification used to identify a growing area that meets the criteria for the approved classification except under certain conditions described in a conditional area management plan.

 

          (o)  “Conditionally restricted” means a classification used to identify a growing area that meets the criteria for the restricted classification except under certain conditions described in a conditional area management plan.

 

          (p)  “Conveyance” means any type of container used to transport shellfish.

 

          (q)  “Critical control point (CCP)” means a point, step, or procedure in a food process at which control may be applied, and a food safety hazard may as a result be prevented, eliminated, or reduced to acceptable levels.

 

          (r)  “Critical deficiency” means a condition or practice which:

 

(1)  Results in the production of a product that is unwholesome; or

 

(2)  Presents a threat to the health or safety of the consumer.

 

          (s)  “Critical limit” means the minimum or maximum value at which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.

 

          (t)  “Cull” means to remove dead or unsafe shellstock from a lot of shellstock.

 

          (u)  “Dealer” means a person to whom certification is issued for the activities of shellstock shipper, reshipper, shucker-packer, repacker, or depuration processor.

 

          (v)  “Department” means the New Hampshire department of health and human services.

 

          (w)  “Depuration” means the process of reducing the pathogenic organisms that may be present in shellstock by using a controlled aquatic environment as the treatment process.

 

          (x)  “Depuration processor (DP)” means a person who harvests or receives shellstock from growing areas in the approved classification or conditionally approved classification, restricted classification, or conditionally restricted classification in the open status and submits such shellstock to an approved depuration process.

 

          (y)  “Direct marketing” means the sale for human consumption of shellfish which:

 

(1)  Does not require depuration or relaying prior to sale; or

 

(2)  Has been subjected to depuration or relaying activities.

 

          (z)  “Dry storage” means the storage of shellstock out of water.

 

          (aa)  “Facility” means an establishment, equipment, and premises designed, built, or installed to perform a specific function.

 

          (ab)  “Float aquaculture” means open water aquaculture where the shellfish product is suspended at the water surface using floats.

 

          (ac)  “Growing area” means any site which supports or could support the propagation of shellstock by natural or artificial means.

 

          (ad)  “Harvest” means the act of removing shellstock from growing areas and its placement on or in a manmade conveyance or other means of transport.

 

          (ae)  “Harvest area” means an area that contains commercial quantities of shellstock and may include aquaculture sites and facilities.

 

          (af)  “Harvester” means a person who takes shellstock by any means from a growing area.

 

          (ag)  “Hazard analysis critical control point (HACCP)” means a systematic, science-based approach used in food production as a means to ensure food safety which is based upon the 7 principles identified by the National Advisory Committee on Microbiological Criteria for Foods.

 

          (ah)  “Hazard analysis critical control point (HACCP) plan” means a written document that delineates the formal procedures that a dealer follows to implement the HACCP requirements set forth in 21 CFR 123.6 as adopted by the Interstate Shellfish Sanitation Conference.

 

          (ai)  “Heat shock” means the process of subjecting shellstock to any form of heat treatment prior to shucking, including steam, hot water, or dry heat, to facilitate removal of the meat from the shell without substantially altering the physical or organoleptic characteristics of the shellfish.

 

          (aj)  “In-shell product” means non-living, processed shellfish with one or both shells present.

 

          (ak)  “In-shell product packing” means the process of placing in-shell product into containers for introduction into commerce.

 

          (al)  “Inspection item” means one of the standard criteria listed in the NSSP Plant Inspection Form under which single or multiple observations of specific critical, key, or other deficiencies may be debited.

 

          (am)  “Interstate Certified Shellfish Shippers List (ICSSL)” means a United States Food and Drug Administration (FDA) publication of shellfish dealers, domestic and foreign, who have been certified by a state or foreign authority as meeting the public health control measures specified in the NSSP Guide for the Control of Molluscan Shellfish, 2013 Revision.

 

(an)  “Interstate Shellfish Sanitation Conference (ISSC)” means the organization which consists of agencies from shellfish producing and receiving states, the FDA, the shellfish industry, the National Marine Fisheries Service of the United States, the US Department of Commerce, and the US Environmental Protection Agency (EPA).  The ISSC provides the formal structure wherein state regulatory authorities, with FDA concurrence, can establish updated guidelines and procedures for sanitary control of the shellfish industry.

 

          (ao)  “Key deficiency” means a condition or practice that might result in adulterated, decomposed, misbranded, or unwholesome product.

 

          (ap)  “Label” means any written, printed, or graphic matter affixed to or appearing upon any package containing shellfish.

 

          (aq)  “Landing” means the point at which shellstock is put on land or a dock.

 

          (ar)  “Lot of in-shell product” means a single type of container of in-shell product of no more than one day’s harvest from a single defined growing area.

 

          (as)  “Lot of shellstock” means a single type of bulk shellstock or containers of shellstock of no more than one day’s harvest from a single defined growing area gathered by one or more harvesters.  A lot may also be used to segregate the harvest times and intended uses of shellstock for the purposes of complying with time to temperature requirements.

 

          (at)  “Lot of shellstock for depuration” means shellstock harvested from a single defined growing area during a single day’s harvest and delivered to one depuration plant.

 

          (au)  “Lot of shuck shellfish” means a collection of containers of no more than one day’s shucked shellfish product produced under conditions as nearly uniform as possible, and designated by a common container code or marking.

 

          (av)  “Marina” means any water area with a structure, such as docks, basins, and floating docks, which is:

 

(1)  Used for docking or otherwise mooring vessels; and

 

(2)  Constructed to provide temporary or permanent docking space for more than 10 boats.

 

          (aw)  “Monoculture” means the culture of a single bivalve species.

 

          (ax)  “National Shellfish Sanitation Program (NSSP)” means the cooperative program between the states, the FDA, and the shellfish industry for the sanitary control of shellfish that is adequate to ensure that the shellfish produced in accordance with the NSSP Guide for the Control of Molluscan Shellfish, 2013 Revision, will be safe and sanitary.

 

          (ay)  “Open water aquaculture” means the cultivation of bivalve shellfish in natural shellfish growing areas.

 

          (az)  “Organoleptic” means aspects of a food substance that stimulate the senses, including taste, touch, color, odor, and feel, in cases where dryness, moisture, and stale-fresh factors are to be considered.

 

          (ba)  “Other deficiency” means a condition or practice that is not defined as a critical or key deficiency and is not in accordance with the requirements of NSSP Guide for the Control of Molluscan Shellfish, 2013 Revision, as incorporated by reference and amended in He-P 2152.01.

 

          (bb)  “Performance based inspection” means when a dealer who has demonstrated a history of no critical deficiencies, no more than one key deficiency, and no more than 2 other deficiencies in any one inspection for a 3-year period, and therefore requires no more than one inspection per certification period.

 

          (bc)  “Person” means any individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind, and any partnership, association, corporation, or other entity.  Person includes the federal government, the state, and any other public or private entity.

 

          (bd)  “Poisonous or deleterious substance” means a toxic substance occurring naturally or added to the environment for which a regulatory tolerance limit or action level has been established in shellfish to protect public health.

 

          (be)  “Polyculture” means the cultivation of:

 

(1)  Two or more species of shellfish; or

 

(2)  Shellfish with other species in a common environment.

 

          (bf)  “Post harvest processing” means any process that has been validated using NSSP validation procedures which reduces the levels of pathogenic hazards to below the appropriate FDA action level or, in the absence of such a level, below the appropriate level as determined by the ISSC.

 

          (bg)  “Post harvest processor” means a designation given to a shellfish dealer that has incorporated a post harvest process.

 

          (bh) “Primary dealer” means those certified dealers who receive, purchase, and/or pack shellfish directly from harvesters.

 

          (bi)  “Processing” means any activity associated with the handling, shucking, freezing, packing, labeling, or storing of shellfish in preparation for distribution.  This term includes the activities of a shellstock shipper, shucker-packer, repacker, reshipper, or depuration processor.

 

          (bj)  “Prohibited” means a classification used to identify a growing area where the harvest of shellstock for any purpose, except depletion or gathering of seed for aquaculture, is not permitted.

 

          (bk)  “Raw” means shellfish that have not been thermally processed:

 

(1)  To an internal temperature of 145ş Fahrenheit or greater for 15 seconds, or the equivalent; or

 

(2)  Otherwise altering the organoleptic characteristics.

 

          (bl)  “Receipt of shellfish” means the critical control point where a shellfish dealer takes possession of shellfish at a location where it will be processed and/or will be shipped to another dealer or retail establishment, monitors the receiving critical control points to ensure compliance with critical limits, and monitors storage and shipping critical control points.

 

          (bm)  “Relay” means to transfer shellstock from a growing area classified as restricted or conditionally restricted to a growing area classified as approved or conditionally approved for the purpose of reducing pathogens as measured by the coliform indicator group or poisonous or deleterious substances that may be present in the shellstock by using the ambient environment as the treatment process.

 

          (bn)  “Repacker (RP)” means a person other than the original certified shucker-packer who repackages shucked shellfish into other containers.

 

          (bo)  “Repacking in-shell product” means the practice of removing in-shell product from containers and placing it into other containers.

 

          (bp)  “Repacking shellstock” means the practice of removing shellstock from containers and placing it into other containers.

 

          (bq)  “Reshipper (RS)” means a person who purchases shellfish from dealers and sells the product without repacking or relabeling to other dealers, wholesalers, or retailers.

 

          (br)  “Restricted” means a classification used to identify a growing area where harvesting shall be by special certificate and the shellstock, following harvest, is subjected to a suitable and effective treatment process through relaying or depuration.

 

          (bs)  “Restricted use shellstock” means shellstock that is harvested from growing areas classified as approved or conditionally approved in the open status and under conditions that do not allow the sale of the shellstock for direct marketing for raw consumption. Restricted use shellstock is identified with a tag indicating that the shellstock is intended for further processing prior to distribution to retail or food service.

 

          (bt)  “Sanitary survey” means the written evaluation report of all environmental factors, including actual and potential pollution sources, which have a bearing on the water quality in a shellfish growing area.

 

          (bu)  “Sanitation control record” means records that document the monitoring of sanitation practices and conditions during processing.

 

          (bv)  “Sanitize” means to adequately treat food contact surfaces by a process that is effective in:

 

(1)  Destroying vegetative cells of microorganisms of public health significance;

 

(2)  Substantially reducing the numbers of other undesirable microorganisms; and

 

(3)  Not adversely affecting the product or its safety for the consumer.

 

          (bw)  “Seed” means shellstock that is less than market size.

 

          (bx)  “Shellfish” means all species of:

 

(1)  Oysters, clams or mussels, whether:

 

a.  Shucked or in the shell;

 

b.  Raw, including post harvest processed;

 

c.  Frozen or unfrozen; or

 

d.  Whole or in part; and

 

(2)  Scallops in any form, except when the final product form is the abductor muscle only.

 

          (by)  “Shellstock” means live molluscan shellfish in the shell.

 

          (bz)  “Shellstock packing” means the process of placing shellstock into containers for introduction into commerce.

 

          (ca)  “Shellstock shipper” means a dealer who grows, harvests, buys, or repacks and sells shellstock, who is not authorized to shuck shellfish nor to repack shucked shellfish, and who is permitted to buy, repack, and sell in-shell product as well as ship shucked shellfish.

 

          (cb)  “Shucker-packer (SP)” means a person who shucks and packs shellfish.  A shucker-packer may act as a shellstock shipper or reshipper or may repack shellfish originating from other certified dealers.

 

          (cc)  “State shellfish standardization officer” means a person that has successfully completed the FDA standardization training course and the field evaluation phase of shellfish plant inspection with an FDA standardization officer.

 

          (cd)  “Swing deficiency” means a deficiency that, depending upon the severity and circumstances, may be either a critical or key deficiency.

 

          (ce)  “Transaction record” means the form or forms used to document each purchase or sale of shellfish at the wholesale level, and includes shellfish harvest and sales records, ledgers, purchase records, invoices, and bills of lading.

 

          (cf)  “Trip records” means a form of written documentation that includes the date and time of each lot of shellfish harvested.

 

          (cg)  “Vehicle” means a machine or conveyance, including watercraft and aircraft, used to move or transport shellfish.

 

          (ch)  “Wet storage” means the storage, by a dealer, of shellstock from growing areas in the approved classification or in the open status of the conditionally approved classification in containers or floats in natural bodies of water or in tanks containing natural or synthetic seawater at any permitted land-based activity or facility.

 

Source.  (See Revision Note at part heading for He-P 2150) #10704, eff 10-23-14

 

PART He-P 2152  NEW HAMPSHIRE SHELLFISH SANITATION RULES:  INCORPORATION OF THE NATIONAL SHELLFISH SANITATION PROGRAM GUIDE FOR THE CONTROL OF MOLLUSCAN SHELLFISH

 

He-P 2152.01  Incorporation of the NSSP Guide for the Control of Molluscan Shellfish, 2013 Revision.

 

          (a)  All certificate holders shall comply with the United States Department of Health and Human Services, Public Health Services, Food and Drug Administration, National Shellfish Sanitation Program (NSSP) Guide for the Control of Molluscan Shellfish, 2013 Revision, henceforth referred to as the “NSSP Guide (2013),” available as noted in Appendix A.

 

          (b)  The following amendments shall apply to the NSSP Guide (2013) incorporated in (a) above:

 

(1)  Notwithstanding Chapter 13.01.A.(3), all shipments of shellstock shall be required to have a continual time/temperature recording device.

 

(c) The NSSP Guide (2013) may be viewed on the FDA website at http://www.fda.gov/downloads/Food/GuidanceRegulation/FederalStateFoodPrograms/UCM415522.pdf, or a copy may be obtained from the Interstate Shellfish Sanitation Conference, 209-2 Dawson Road, Columbia, SC 29223.

 

Source.  (See Revision Note at part heading for He-P 2150) #10704, eff 10-23-14

 

PART He-P 2153  NEW HAMPSHIRE SHELLFISH SANITATION RULES: APPLICATION AND CERTIFICATE PROCEDURE

 

          He-P 2153.01  Initial Certificate Application Requirements.

 

          (a)  Each applicant for a certificate shall submit the following to the department:

 

(1)  A completed application form entitled “Application for Shellfish Certification” (SSAPP 10-01-14), signed and dated by the applicant or the person who represents the applicant and certifying the following:

 

“I certify that all information provided in or attached to this application is complete, accurate and up-to-date as of the date specified below. I further certify that there are no willful misrepresentations of the answers to questions herein, and that I have made no omissions with respect to any of my answers to the questions presented. I understand that it is my responsibility to immediately notify the Food Protection Section with regard to any changes, corrections or updates to the information provided.”;

 

(2)  A check or money order for the applicable fees, in accordance with He-P 2153.05(a) and (d);

 

(3)  Water system documentation, which meets the requirements outlined in He-P 2153.06;

 

(4)  Wastewater system documentation, which meets the requirements outlined in He-P 2153.07;

 

(5)  A completed “Plan Review Application” (SSFPAPP 10-01-14), signed and dated by the applicant or the person who represents the applicant, if required by He-P 2153.12(a) and (b), and if not already submitted for review; and

 

(6)  A HACCP plan as required in He-P 2153.13.

 

          (b)  The applicant shall mail or hand deliver the documents to:

 

Department of Health and Human Services

Bureau of Finance/Receipts Unit – Food Protection

129 Pleasant Street

Concord, NH 03301

 

Source.  (See Revision Note at part heading for He-P 2150) #10704, eff 10-23-14

 

          He-P 2153.02  Processing of Initial Applications and Issuance of Certificates.

 

          (a)  Applications shall be processed in accordance with RSA 541-A:29.

 

          (b)  An application for an initial certificate shall be complete when the department determines that all items required by He-P 2153.01(a) have been received.

 

          (c)  If an application does not contain all of the items required by He-P 2153.01(a), the department shall notify the applicant in writing within 10 business days specifying any information or supporting documentation required to be submitted before the application can be processed.

 

          (d)  If after written notice in (b) above the applicant fails to provide the missing information or supporting documentation, including payment of the required fee, within 30 days of such notice:

 

(1)  The application shall be considered incomplete and shall not be processed; and

 

(2)  The applicant may reapply by submitting a new initial application in accordance with He-P 2153.01(a).

 

          (e)  Application fees shall not be transferable to any other application(s).

 

          (f)  Application fees shall be nonrefundable.

 

          (g)  Following an application and inspection, conducted pursuant to RSA 143:4, and in accordance with He-P 2154 an initial certification shall be issued if the department determines that an applicant is in compliance with RSA 143:20–28 and these rules.

 

          (h)  All certificates issued in accordance with RSA 143:22 shall be issued for a specific certificate classification under He-P 2153.04.

 

          (i)  All certificates shall be non-transferable by person or location.

 

          (j)  Certificates shall be posted at all times in an area that is conspicuous to patrons.

 

Source.  (See Revision Note at part heading for He-P 2150) #10704, eff 10-23-14

 

          He-P 2153.03  Certificate Expirations and Procedures for Renewals.

 

          (a)  All certificates issued shall expire pursuant to RSA 143:22.

 

          (b)  Each dealer shall apply for recertification via an application form pursuant to He-P 2153.01(a)(1) at least 30 days prior to the expiration of the current certificate.

 

          (c)  The certificate holder shall submit with the renewal application:

 

(1)  The materials required by He-P 2153.01(a)(1) through (a)(4);

 

(2)  The materials required by He-P 2153.01(a)(5) and (6) if these have been updated within the most recent certification period and not submitted in accordance with He-P 2153.12 and He-P 2153.13, respectively;

 

(3)  A request for renewal of any existing variances previously granted by the department, in accordance with He-P 2153.14, if applicable; and

 

(4)  Every other year, documentation of training required by He-P 2153.15.

 

          (d)  A certificate shall be renewed if the department determines that the certificate holder:

 

(1)  Has submitted a completed application containing all the items required by (c) above, as applicable, prior to the expiration of the current certificate;

 

(2)  Meets the requirements of He-P 2154.01(c) and (e);

 

(3) Has submitted a compliance schedule that has been accepted by the department and implemented by the certificate holder to address any new deficiencies not corrected during the inspection;

 

(4)  Is found to be in compliance with RSA 143, RSA 143:20–28, and He-P 2150–2159 at a renewal inspection, as applicable;

 

(5)  Has paid all outstanding fees and fines in full; and

 

(6)  Has, every other year, met the training requirement in He-P 2153.13.

 

          (e)  If a certificate holder fails to submit a complete application for renewal as required under (b) and (c) above, the dealer shall cease operation the day after the certificate expires, and shall not operate until a certificate is obtained.

 

Source.  (See Revision Note at part heading for He-P 2150) #10704, eff 10-23-14

 

          He-P 2153.04  Designations and Permits.

 

          (a)  When the department certifies a person to become a dealer, the department shall notify the FDA for the purposes of having the dealer listed in the Interstate Certified Shellfish Shippers List (ICSSL).  The department shall include any permit designation to be included in the ICSSL.

 

          (b)  Certification classifications and permit designations shall be as follows:

 

(1)  Certification classifications:

 

a.  RS – Reshipper;

 

b.  SS – Shellstock shipper;

 

c.  RP – Repacker;

 

d.  SP – Shucker-packer; and

 

e.  DP – Depuration processor; and

 

(2)  Permit designations:

 

a.  PHP – Post harvest processing;

 

b.  AQ – Aquaculture; and

 

c.  WS – Wet storage.

 

          (c)  The department shall issue only one certification number to an individual dealer for a particular location.

 

          (d)  The department shall issue more than one certification number to an individual dealer provided that each business is maintained as a separate entity and does not operate at the same location, each of which shall require separate applications and separate fees.

 

          (e)  The department shall allow separately certified dealers to share a facility at a single location.

 

Source.  (See Revision Note at part heading for He-P 2150) #10704, eff 10-23-14

 

          He-P 2153.05  Fees.

 

          (a)  For each classification of certification, the applicant shall pay the following annual fees:

 

(1)  Reshipper, $175;

 

(2)  Shellstock shipper, $350;

 

(3)  Repacker, $875;

 

(4)  Shucker-packer, $1,100, and

 

(5)  Depuration processor, $1,750.

 

          (b)  For each permit, the applicant shall pay the following annual fees:

 

(1)  Shellstock relaying permit, $50; and

 

(2)  Wet storage permit, $50.

 

          (c)  Certificate holders shall be responsible for payment of a $100 fee for each inspection conducted after the second inspection conducted in any licensing period, except that the minimum number of inspections conducted during the period of certification as are required by the NSSP Guide (2013) shall not be included in this count.

 

          (d)  An applicant or certificate holder shall pay a fee of $75 for each plan review submitted under He-P 2153.12.

 

          (e)  All fees shall be non-transferable and non-refundable.

 

          (f)  Payment of any fee to the department shall meet the following requirements:

 

(1)  Payment shall be made in the form of check or money order made payable to the “Treasurer, State of New Hampshire” in the exact amount due;

 

(2)  Money order or certified check shall be required when an applicant or certificate holder has issued payment to the department by check, and such check was returned for insufficient funds; and

 

(3)  Any payment made to the department by check which is returned for insufficient funds, and which an individual, applicant, or certificate holder has not made good by submitting a money order or certified check within 2 business days of notification by the department, including any penalty assessment allowed by RSA 6:11-a, shall be grounds for denial or revocation of the certificate.

 

Source.  (See Revision Note at part heading for He-P 2150) #10704, eff 10-23-14

 

          He-P 2153.06  Water System Requirements.

 

          (a)  Certificate holders which own and operate their own public water systems, as defined by RSA 485:1-a, XV, shall indicate, as part of their application, the Public Water System (PWS) identification number which has been assigned by the New Hampshire department of environmental services (DES).

 

(b)  For an application to be approved, certificate holders which own and operate their own public water systems regulated by DES shall:

 

(1)  Maintain compliance with all applicable water quality standards and monitoring and reporting requirements of Env-Dw 717 or successor rules in subtitle Env-Dw; or

 

(2)  Maintain compliance with the requested actions in a letter of deficiency, or the required actions of an administrative order, issued by DES and established to obtain compliance with the regulations cited in (1) above.

 

          (c)  Certificate holders which are classified as public water systems, as defined by RSA 485:1-a, XV, but whose water system infrastructure is owned by another party, shall indicate, as part of their application, the private water system (PWS) identification number which has been assigned by DES.

 

          (d) For an application under this paragraph to be approved, the owner of the water system infrastructure shall:

 

(1) Maintain compliance with all applicable water quality standards and monitoring and reporting requirements of Env-Dw 717 or successor rules in Env-Dw; or

 

(2)  Maintain compliance with the requested actions in a letter of deficiency, or the required actions of an administrative order, issued by the DES and established to obtain compliance with the regulations cited in (1) above.

 

          (e)  Certificate holders which purchase their water from other public water systems, as defined by RSA 485:1-a, XV, and therefore do not fall under (a) above, shall provide proof of their water source along with the application.

 

          (f)  Certificate holders which do not fall under (a) through (e) above, and are instead served by a water source other than a public water system, shall submit with the initial and renewal applications the written results of a laboratory analysis of the water intended for use, which tests the level of the following:

 

(1)  Bacteria;

 

(2)  Nitrates; and

 

(3)  Nitrites.

 

          (g)  The analyses required by (f) above shall be conducted not more than 6 months prior to the date of the application by a laboratory accredited by DES to perform such tests in accordance with Env-C 300.

 

          (h)  For an application to be approved, the results of the water analysis shall be as follows:

 

(1)  The bacteria test required under (f) above shall not exceed the maximum contaminant level (MCL) for drinking water prescribed by Env-Dw 700; and

 

(2)  The nitrate and nitrite tests required under (f) above shall not exceed the MCL for drinking water prescribed by Env-Dw 700 for those 2 contaminants.

 

Source.  (See Revision Note at part heading for He-P 2150) #10704, eff 10-23-14

 

          He-P 2153.07  Wastewater System Requirements.

 

          (a)  Certificate holders which discharge their wastewater to either public or private wastewater systems which hold either a state surface water discharge permit or a groundwater discharge permit issued by the New Hampshire department of environmental services (DES), shall provide a copy of this information along with the application.

 

          (b)  Certificate holders which do not discharge their wastewater as described in (a) above shall submit, as part of their application, one of the following:

 

(1)  Both:

 

a.  A copy of the construction approval for the sewage or waste disposal system that indicates that the system is sufficient in capacity to serve the subject shellfish processing plants issued by DES in accordance with RSA 485-A:29 and Env-Wq 1000; and

 

b.  A written statement signed by the applicant containing the following language: “I certify that there has been no increase in the loading on the wastewater system which would cause an exceedance of the capacity of the system approved by the New Hampshire Department of Environmental Services under the provisions of Env-Wq 1000”; or

 

(2)  A written statement signed by the applicant containing the following language: “I certify that the private sewage or waste disposal system serving this certificate holder was constructed prior to 1971 and is presently not in failure.  I further certify that I have not been notified by either the New Hampshire Department of Environmental Services or the local health officer that the system serving this certificate holder is in violation of any state or local statute, administrative rule, ordinance, or bylaw.”

 

          (c)  If there is no increase in the loading of the waste disposal system serving the certificate holder in (b) above, and the applicant is unable to produce the documentation required, the department shall inform DES that the applicant has not complied with (b)(1) above.  In this case, the requirement of (b)(1) above shall be waived.

 

Source.  (See Revision Note at part heading for He-P 2150) #10704, eff 10-23-14

 

          He-P 2153.08  Change in Ownership.

 

          (a)  When there is a change in ownership, the new owner shall submit the items required for initial applicants under He-P 2153.01 to the department at least 30 days prior to the change in ownership.

 

          (b)  Upon receipt and processing of the items required by (a) above, and after an inspection conducted in accordance with He-P 2155, which determines compliance with the NSSP Guide (2013), as incorporated by reference and amended in He-P 2152.01, the department shall issue an initial certification reflecting the change in ownership.

 

          (c)  The issuance of an initial certification due to a change in ownership shall void the certificate of the previous owner on the date the change of ownership occurs.

 

Source.  (See Revision Note at part heading for He-P 2150) #10704, eff 10-23-14

 

          He-P 2153.09  Change in Name.

 

          (a)  When a certificate holder intends to change the name of its business, the certificate holder shall submit a written request to the department for a new certificate at least 30 days prior to the intended date of name change.

 

          (b)  The written request shall include:

 

(1)  The reason for requesting a new certificate;

 

(2)  The name of the business as it appears on the existing certificate;

 

(3)  The name of the business as the certificate holder requests it to appear on the new certificate; and

 

(4)  The date upon which the change in name is intended to occur.

 

          (c)  Following receipt of the items required by (b) above, the department shall issue a revised certificate reflecting the change in name.  The certificate number and expiration date shall remain the same as it was on the immediately preceding certificate.

 

Source.  (See Revision Note at part heading for He-P 2150) #10704, eff 10-23-14

 

          He-P 2153.10  Change in Location.

 

          (a)  When there is a change in location, the certificate holder shall submit the items required for initial certification under He-P 2153.01 to the department at least 30 days prior to the change in location.

 

          (b)  Upon receipt and processing of the items required under (a) above, and after an inspection conducted in accordance with He-P 2155, the department shall issue an initial certification reflecting the change of location.

 

          (c)  The issuance of an initial certification due to a change in location shall void the previous certificate on the date the change of location occurs.

 

          (d)  This section shall not apply to vehicles used to sell wholesale or retail shellfish.

 

Source.  (See Revision Note at part heading for He- P 2150) #10704, eff 10-23-14

 

          He-P 2153.11  Change in Certificate Classification.

 

          (a)  A certificate holder wishing to request an upgrade to a higher-level of certificate as listed in He-P 2153.04 shall:

 

(1)  Be treated as an applicant for a new certificate; and

 

(2)  Apply for a new certificate in accordance with He-P 2153.01.

 

          (b)  The issuance of an initial certification due to an upgrade in certificate classification shall void the previous certificate on the date the upgrade occurs.

 

          (c)  A certificate holder wishing to request a downgrade to a lower level of certificate listed in He-P 2153.04 shall submit a written request for downgrade to the department.

 

          (d)  The written request in (c) above shall include:

 

(1)  The reason for requesting a downgrade; and

 

(2)  The date upon which the downgrade is intended to occur.

 

          (e)  Following receipt of the request under (c) above, the certificate holder shall be issued a revised certificate reflecting the downgrade in the certificate classification.  The certification number and expiration date shall remain the same as it was on the immediately preceding certificate.

 

Source.  (See Revision Note at part heading for He-P 2150) #10704, eff 10-23-14

 

          He-P 2153.12  Submission of Plans and Specifications for New or Remodeled Plants.

 

          (a)  An applicant or certificate holder shall complete and submit a “Plan Review Application” (SSFPAPP 10-01-14) to the department for review and approval.

 

(b)  The application in (a) above shall be submitted at least 45 days prior to:

 

(1)  Constructing a new shellfish processing plant;

 

(2)  Converting an existing structure for use as a shellfish processing plant;

 

(3)  Remodeling a shellfish processing plant; or

 

(4)  Relocating a shellfish processing plant when the relocation also involves (1), (2), or (3) above.

 

          (c)  An applicant or certificate holder shall pay a fee of $75 for each plan review application submitted.

 

          (d)  The department shall review plans for construction, renovation, or structural alterations of a shellfish processing plant for compliance with all applicable sections of RSA 143:20-28 and He-P 2150–2159 and notify the applicant or certificate holder as to whether the plan complies with these requirements.

 

Source.  (See Revision Note at part heading for He-P 2150) #10704, eff 10-23-14

 

He-P 2153.13  Hazard Analysis and Critical Control Point (HACCP) Plan and Sanitation Standard Operating Procedure (SSOP) Requirements.

 

          (a) Every dealer shall establish and implement a written hazard analysis critical control point (HACCP) plan which is specific to:

 

(1)  Each location where shellfish products are processed by that dealer; and

 

(2)  Each kind of shellfish product processed by the dealer.

 

          (b)  At a minimum, the HACCP plan shall include:

 

(1)  A list of the food safety hazards that are reasonably likely to occur for each kind of shellfish product processed by that dealer and identification of preventative measures that shall be applied to control those hazards; and

 

(2) A statement of standard operating procedures for the plan under consideration clearly identifying:

 

a.  Each critical control point;

 

b.  The critical limits for each critical control point;

 

c.  The method and frequency for monitoring and controlling each critical control point by an individual who has successfully completed training in the application of HACCP principles to shellfish processing or who is otherwise qualified through job experience to perform these functions;

 

d. The method and frequency to routinely verify that the dealer is following standard operating procedures and monitoring critical control points;

 

e.  Action to be taken by the dealer if the critical limits for each critical control point are not met; and

 

f.  Records to be maintained by the dealer to demonstrate that the HACCP plan is properly operated and managed.

 

          (c)  The department shall review HACCP plans for compliance with all applicable sections of RSA 143:20-28 and He-P 2150–2159 and notify the applicant or certificate holder as to whether the plan complies with these requirements.

 

          (d)  The dealer shall submit an updated or new HACCP plan 45 days prior to whenever a change in the process, location, or product will occur.

 

          (e)  The dealer shall monitor conditions and practices that are both appropriate to the facility and the food being processed and shall maintain sanitation control records in compliance with 21 CFR 123.

 

          (f)  The dealer shall maintain possession of the HACCP plan at all times.

 

Source.  (See Revision Note at part heading for He-P 2150) #10704, eff 10-23-14

 

          He-P 2153.14  Variances.

 

          (a)  Applicants or certificate holders seeking variances from specific rules, or from items in the NSSP Guide (2013), as incorporated by reference in He-P 2152.01, shall submit a “Variance Request Form” (SSVARFORM 10-01-14) to the:

 

NH Department of Health and Human Services

Division of Public Health Services

Food Protection Section

29 Hazen Drive

Concord, NH  03301

(603) 271-4589

 

          (b)  The variance request shall also include submission of a HACCP plan if required under He-P 2154.13.

 

          (c)  The commissioner shall approve a request for variance if:

 

(1)  The commissioner concludes that authorizing deviation from strict compliance with the rule or the item in the NSSP Guide (2013), as incorporated by reference and amended in He-P 2152.01, from which a variance is sought does not contradict the intent of the rule or the NSSP Guide (2013) item; and

 

(2)  The alternative proposed by the applicant or certificate holder ensures that the objective or intent of the rule or item in the NSSP Guide (2013), as incorporated by reference and amended in He-P 2152.01, from which a variance is sought will be accomplished.

 

          (d)  The commissioner shall deny a request for a variance if:

 

(1)  The request does not meet the requirements of (a) and (b) above; or

 

(2)  The request does not meet the criteria for approval in accordance with (c) above.

 

          (e)  If a variance is approved, the certificate holder’s subsequent compliance with the alternatives approved in the variance shall be considered equivalent to complying with the rule or the NSSP Guide (2013), as incorporated by reference and amended in He-P 2152.01.

 

          (f)  A variance shall be approved for one year or until the expiration of the current certificate, unless otherwise specified by the department.

 

          (g)  The certificate holder shall reapply for a variance along with each annual request for recertification.

 

          (h)  No request for a variance concerning any statutory provision or the rules of other state agencies referred to in this chapter shall be approved.

 

Source.  (See Revision Note at part heading for He-P 2150) #10704, eff 10-23-14

 

          He-P 2153.15  Training.

 

          (a)  Dealers shall complete department approved training every 2 years.  The training shall include required processing, handling, and transportation practices as determined by the department.

 

          (b)  A dealer shall provide proof of successful completion of the required training to the department within 90 days of initial certification and prior to each annual recertification.

 

          (c)  At a minimum, one individual involved in the dealer’s shellfish operations shall obtain the required training.

 

          (d)  The dealer shall maintain records of the completed training.

 

          (e)  Failure to submit confirmation of the training certificate shall result in enforcement pursuant to He-P 2155.03.

 

Source.  (See Revision Note at part heading for He-P 2150) #10704, eff 10-23-14

 

PART He-P 2154  NEW HAMPSHIRE SHELLFISH SANITATION RULES:  INSPECTIONS AND COMPLIANCE

 

          He-P 2154.01  Inspections.

 

          (a)  For the purpose of determining compliance with RSA 143:20-28 and He-P 2150–2159, as authorized by RSA 143:4 and RSA 143:22, the applicant or certificate holder shall admit and allow any department representative at any time to enter and inspect the facilities, activities, or equipment.

 

          (b)  An applicant requesting certification shall be subject to a comprehensive, onsite inspection in order to determine compliance with RSA 143:20-28 and He-P 2150–2159.

 

          (c)  Certification shall be given only to applicants who meet the following requirements:

 

(1)  Does not exceed the following HACCP plan and HACCP plan implementation deficiency limits:

 

a.  No critical deficiencies;

 

b.  Not more than 2 key deficiencies; and

 

c.  Not more than 2 other deficiencies; and

 

(2)  Does not exceed the following sanitation and additional NSSP Guide (2013) deficiency limits:

 

a.  No critical deficiencies;

 

b.  Not more than 2 key deficiencies; and

 

c.  Not more than 3 other deficiencies.

 

          (d)  A compliance schedule shall be issued with the certification if there are any deficiencies identified which were not corrected by the dealer during the inspection.

 

          (e)  A dealer shall make application for certification renewal annually at the time specified by the department.  The department shall not renew the certification for any dealer until the requirements of (c) above are met.  The number of deficiencies from an existing compliance schedule approved by the department shall be combined with any new deficiencies identified during the certification renewal inspection when determining compliance with (c) above.

 

          (f)  The dealer shall agree to a compliance schedule to address any new deficiencies not corrected by the dealer during the inspection.

 

          (g)  After the dealer is certified, the department shall make unannounced inspections of the dealer’s facilities during periods of activity, and at the following minimum frequencies:

 

(1)  Within 30 days of beginning production if the dealer was certified on the basis of a pre-operational inspection;

 

(2)  At least monthly for dealer facilities certified as depuration processors;

 

(3)  At least quarterly for production activities certified as shucker-packer or repacker; and

 

(4)  At least semiannually for other dealer activities.

 

          (h)  To be eligible for the department’s performance based inspection program (PIP), the dealer shall have demonstrated a history of satisfactory compliance for the previous 3-year period, including, but not limited to, the following:

 

(1)  Full compliance with the minimum inspection frequency listed in (g) above;

 

(2)  Annual recertification of the dealer by the department, with no lapses in certification;

 

(3)  Verification that no critical deficiencies, no more than one key deficiency, and no more than 2 other deficiencies have occurred in any one inspection;