Alabama Administrative Code › Title 420 - ALABAMA STATE BOARD OF HEALTH › Chapter 420-3-16 - PRODUCTION, PROCESSING, HANDLING OR DISTRIBUTION OF MILK, MILK PRODUCTS AND FROZEN DESSERTS › APPENDICES › Appendix J - STANDARDS FOR THE FABRICATION OF SINGLE-SERVICE CONTAINERS AND CLOSURES FOR MILK AND MILK PRODUCTS

Current through Register Vol. 42, No. 9, June 28, 2024
PREFACE
Single-service containers and closures have been used in the
				  dairy industry for many years. Industry applied quality assurance controls for
				  manufacturing and handling of the materials have made it possible for these
				  products to reach the point of use in a sanitary condition free from toxic
				  materials which may migrate into milk or milk products.
Within recent years, single-service container manufacturers
				  have introduced new materials, equipment, and design concepts for these
				  containers and closures. Evaluation of the industry's basic manufacturing and
				  handling techniques and establishment of sanitation criteria assure that
				  single-service containers and closures and the materials from which they are
				  formed are safe and in compliance with bacteriological standards of
				  420-3-16-.10(12).
STANDARDS FOR THE FABRICATION OF SINGLE-SERVICE
				  CONTAINERS AND CLOSURES FOR MILK AND MILK PRODUCTS
A.
PURPOSE AND SCOPE
These rules will serve to ensure the production of sanitary
				  containers and closures for milk and milk products, as defined in Rule
				  420-3-16.
The requirements of these rules shall apply to all blank
				  fabricators, pre-form bottle manufacturers, single-service glass container
				  manufacturers, converters, printers, closure manufacturers, plastic laminators,
				  sheet formers, blow molders, vacuum formers, plastic extruders, injection
				  molders, pre-formers, manufacturers of valves, tubes, dispensing devices,
				  non-sterile sample containers, and any other similar plants. These also apply
				  to fabricating plants producing a component part(s), including fabricators of
				  film and/or closures which may become a product-contact surface and plants
				  assembling components into a final assembled product. These requirements shall
				  not apply to paper mills or resin manufacturing plants.
Milk and food plants manufacturing and/or selling containers
				  to other milk plants, as defined in Rule 420-3-16, excluding milk plants that
				  condense and/or dry milk or milk products, shall meet all the requirements of
				  this rule.
Grade "A" milk plants, as defined in the
Grade "A"
				  Pasteurized Milk Ordinance (PMO)
excluding milk plants that condense
				  and/or dry milk or milk products, shall use single-service containers and
				  closures from plants certified and listed in the electronic publication of the
Sanitation Compliance and Enforcement Ratings of Interstate Milk
				  Shippers
(IMS List).
The
PMO
provides certain criteria for the
				  listing of certified single-service manufacturers in the current publication of
				  the IMS List (refer to Section E).
B.
DEFINITIONS
The following definitions shall be employed in the
				  application of these sanitation standards:
1. "
Broke and Trim
" shall mean paper and
				  paperboard that have been discarded anywhere in the process of manufacture,
				  such as on paper-making machines in the form of trim. This may also include
				  unprinted trim from the converting process, provided the trim has been handled,
				  treated, and transported in a clean, sanitary manner.
2. "
Certified Single-Service Consultant (SSC)"
shall mean an individual who has been certified by the Public Health
				  Service/Food and Drug Administration (PHS/FDA), has a valid certificate of
				  qualification to conduct the certification and listing of foreign
				  single-service containers and/or closures for milk and/or milk products
				  manufacturers on the IMS List, and does not have direct responsibility for the
				  routine regulatory inspection and enforcement or regulatory auditing of the
				  foreign single-service containers and/or closures manufacturer to be
				  certified.
3. "
Closure
" shall mean a cap, lid, seal, tube,
				  valve, lid material, or other device in or on a container used for the purpose
				  of enclosing or dispensing the contents.
4. "
Coatings
" shall mean any layer or covering
				  which is applied to the product-contact surface.
5. "
Component Part
" shall mean any item that by
				  itself, does not perform any function, but when assembled with one (1) or more
				  component parts or closures, becomes a part of the single- service container or
				  closure. These may include, but are not limited to blanks, sheeting, valves and
				  valve parts, tubes, dispensing devices, and sampling containers. All material
				  used for fabrication of a component part shall meet the requirements of the
FFD& CA
as amended.
6. "
Manufacturer
" shall mean any person or
				  company in the business of manufacturing a single-service container or closure
				  for the packaging or sampling of a Grade "A" milk and/or milk product.
7. "
Manufacturing Line
" shall mean a
				  manufacturing process such as injection molding, extrusion, blow-molding,
				  etc.
8. "
Metals
" shall mean those metals that are
				  non-toxic, nonabsorbent, and corrosion-resistant under conditions of intended
				  use.
9. "
Non-toxic Materials
" shall mean materials
				  that are free of substances which may render the product injurious to health or
				  which may adversely affect the flavor, odor, composition, or bacteriological
				  quality of the product and meet the requirements of the
FFD&CA
as amended.
10. "
Paper Stock
" shall mean any paper made from
				  the following materials:
a. Paper and paperboard manufactured from clean, sanitary,
				  virgin chemical or mechanical pulp or from "broke and trim" of such paper and
				  paperboard, provided they have been handled, treated, and stored in a clean,
				  sanitary manner or reclaimed fiber using acceptable or approved protocol in
				  compliance with 21 CFR
				  176.260.
b. Components meeting the requirements of the
FFD&CA
as amended.
11.
"Plastic Molding, Forming, Extrusion, and
				  Laminating Resins"
shall mean:
a. Resins or an intimate admixture of resins with other
				  ingredients which meet the requirements of the
FFD&CA
as
				  amended.
b. Plastic composed solely of clean cuttings or regrind,
				  provided they have been handled and maintained in a clean, sanitary
				  manner.
c. Recycled plastic material when it complies with a protocol
				  that has been reviewed and accepted by FDA.
12. "
Pre-forms
" shall mean a component not in
				  final form for filling.
13. "
Product-Contact Surface
" shall mean those
				  surfaces of the container or closure with which the product comes in
				  contact.
14. "
Production Scrap
" shall mean material which
				  remains from the manufacture of single-service containers or closures that has
				  been handled or treated in such a manner that it does not comply with the
				  definition for "broke and trim" or "regrind," but may be collected for
				  recycling. It may contain material such as containers or trim that have fallen
				  on the floor.
15. "
Regrind
" shall mean clean plastic material
				  that is trimmed from the container or closure, and imperfectly formed
				  containers or closures, which result from the manufacture of single-service
				  containers and closures, provided it is handled in a clean, sanitary manner.
				  This may be in its trimmed or molded form and ground in a suitable grinder
				  within the plant. It shall not include any material, container, or closure
				  which comes from an unapproved source or whose source chemical content or
				  treatment is unknown, or which may have poisonous or deleterious material
				  retained in the plastic which migrates to the food at levels exceeding
				  regulatory levels. Regrind, when transported from one (1) approved plant to
				  another, shall be shipped in suitable, clean, sealed, properly labeled
				  containers. This definition shall not preclude the use of regrind plastic
				  material when it complies with a protocol that has been reviewed and accepted
				  by FDA.
16. "
Sample Set
" shall mean:
a. For the rinse test, a minimum of four (4) containers shall
				  be tested.
b. For the swab test, a minimum of four (4), 50 square
				  centimeter areas of surface from separate containers shall be tested. In the
				  case of containers or closures with a product-contact surface area smaller than
				  50 square centimeters, more than four (4) containers or closures to equal at
				  least 50 square centimeters times four (4) shall be required to be
				  swabbed.
17. "
Sanitization
" shall mean the application of
				  any effective method or substance to properly cleaned surfaces for the
				  destruction of pathogens and other microorganisms as far as is practicable.
				  Such treatment shall not adversely affect the equipment, the milk and/or milk
				  product, or the health of consumers, and shall be acceptable to the Health
				  Officer. Methods of sanitization shall meet the requirements contained in
				  Appendix F.
18. "
Single-Service Articles
" shall mean
				  articles that are constructed wholly, in part, or in combination from paper,
				  paperboard, molded pulp, plastic, metals, coatings, or similar materials and
				  intended by the manufacturer for one (1) usage only.
19. "
Single-Service Container
" shall mean any
				  container having a milk or milk product-contact surface and used in the
				  packaging, handling, or storage of Grade "A" milk and/or milk products which is
				  intended for one (1) use only.
20.
"Single-Service Containers and/or Closures
				  Manufacturer Certification"
shall mean the certification conducted by a
				  Milk Sanitation Rating Officer (SRO) for U.S. manufacturers of single-service
				  containers and/or closures for milk and/or milk products; or a Third Party
				  Certifier's (TPC's) Milk Sanitation Rating Officer (SRO) or a Certified
				  Single-Service Consultant (SSC) for foreign manufacturers of single-service
				  containers and/or closures for milk and/or milk products, which measures the
				  degree to which the provisions of Appendix J of this rule are being complied
				  with by the single-service containers and/or closures manufacturer for
				  inclusion on the IMS List. The certification is based on compliance with the
				  requirements of Appendix J of this rule and is conducted in accordance with the
				  procedures set forth in the
Methods of Making Sanitation Ratings of
				  Milk Shippers and the Certifications/Listings of Single-Service Containers
				  and/or Closures for Milk and/or Milk Products Manufacturers
				  (MMSR).
C.
BACTERIAL STANDARDS AND EXAMINATION OF
				  SINGLE-SERVICE CONTAINERS AND CLOSURES
1. Paper stock shall meet the bacteriological standard of not
				  more than two hundred fifty (250) colonies per gram as determined by the
				  disintegration test. The paper stock supplier shall certify that their paper
				  stock was manufactured in compliance with this standard. This applies only to
				  the paper stock prior to lamination.
2. Where a rinse test can be used, the residual microbial
				  count shall not exceed fifty (50) per container, except that in containers less
				  than 100 mL, the count shall not exceed ten (10), or when using the swab test,
				  not over fifty (50) colonies per 8 square inches (1 per square centimeter) of
				  product-contact surface in three (3) out of four (4) samples taken at random on
				  a given day. All single-service containers and closures shall be free of
				  coliform organisms.
3. During any consecutive six (6) months, at least four (4)
				  sample sets shall be collected in at least four (4) separate months, except
				  when three (3) months show a month containing two (2) sampling dates separated
				  by at least twenty (20) days, and analyzed at an Official, Commercial, or
				  Industry Laboratory approved by the Milk Laboratory Control Agency specifically
				  for the examinations required under these standards (refer to
				  420-3-16-.10(12)
				   for sampling of containers and closures in
				  milk plants).
4. When a single-service container or closure is made from
				  one (1) or more component parts as defined in this document, only those final
				  assembled products that may have product-contact surface(s) shall be sampled
				  and tested for compliance with Section C.
5. A sample set from each manufacturing line, as defined in
				  these rules, shall consist of a minimum of four (4) containers or closures,
				  when the rinse test is used, or a minimum of four (4) 50 square centimeters
				  (cm2) areas of surface, when the swab test is
				  used.
6. The following criteria pertain to manufacturers of
				  pre-forms and bottles preformed at one (1) plant and molded at a second
				  plant:
a. The pre-forming plant shall be IMS Listed but sampling of
				  the pre-forms is not required at this plant.
b. If the first pre-forming plant is also molding the
				  containers into their final form, this plant shall be listed and the containers
				  shall be sampled at this plant.
c. If the second plant, where containers are molded into
				  their final form is a single-service manufacturer, this plant shall be listed
				  and the containers shall be sampled at this plant.
d. If the second plant is a milk plant where containers are
				  molded into their final form, for use only in that milk plant, the milk plant
				  listing is sufficient, but the containers shall be sampled at this
				  plant.
Procedures for obtaining samples and for the laboratory
				  examination of these products are contained in the latest edition of
SMEDP
and shall be in substantial compliance with these
				  methods. Such procedures and examinations shall be evaluated in accordance with
				  the current revision of the
EML.
A list of approved
				  laboratories may be found in the current IMS List which is published by FDA
				  (http://www.fda.gov/food/guidanceregulation/ federalstatefoodprograms/ucm20079
				  65.htm).
D.
FABRICATION PLANT STANDARDS
Note:
To be used in conjunction with Form
				  ADPH-FML-229 (Alabama Department of Public Health Manufacturing Plant
				  Inspection Report [Single-Service Containers, refer to Appendix M]).
1.
FLOORS
a. The floors of all fabricating areas shall be smooth,
				  impervious, and maintained in a state of good repair. The floors of storage
				  rooms may be constructed of tightly joined wood.
b. The joints between the walls and floor shall be tight,
				  impervious and shall have covered or sealed joints.
c. Where floor drains are provided, they shall be properly
				  trapped and floors sloped to drain.
2.
WALLS AND CEILINGS
a. Walls and ceilings of fabricating areas shall have a
				  smooth, cleanable, light-colored surface.
b. Walls and ceilings in fabricating and storage areas shall
				  be kept in good repair.
c. The opening around pipes, tubes, and similar items that
				  extend through the walls and/or ceiling shall be effectively sealed.
3.
DOORS AND WINDOWS
a. All outside openings shall be effectively protected
				  against the entry of insects, rodents, dust, and airborne contamination.
b. All outer doors shall be tight and self-closing.
4.
LIGHTING AND VENTILATION
a. All rooms shall be adequately lighted either by natural
				  light, artificial light, or both. A minimum of twenty (20) foot-candles (220
				  lux) should be maintained in fabricating areas and five (5) foot-candles (55
				  lux) in storage areas. Packaging, sealing, wrapping, labeling, and similar
				  procedures are considered part of the fabricating area.
b. Ventilation shall be sufficient to prevent excessive odors
				  and the formation of excessive water condensation.
c. The intake of all pressure ventilation systems in
				  fabricating areas, whether they are positive or exhaust, shall be properly
				  filtered.
5.
SEPARATE ROOMS
a. All fabricating areas shall be separate from
				  non-fabricating areas to protect against contamination; provided, that if the
				  entire plant meets all sanitation requirements and no source of cross
				  contamination exists, separation between areas is not required.
b. All regrinding of plastic and the shredding, packaging, or
				  baling of paper trim shall be conducted in rooms separate from the fabricating
				  room, except that they may be conducted within the fabricating room, provided
				  such operations are kept clean and free of dust.
6.
TOILET FACILITIES - SEWAGE DISPOSAL
a. Disposal of sewage and other wastes shall be in a public
				  sewage system or in a manner in compliance with applicable state and local
				  regulations.
b. All plumbing shall comply with the applicable state and
				  local regulations.
c. Toilet rooms shall have solid, tight-fitting doors that
				  are self-closing.
d. The toilet room and fixtures shall be maintained in a
				  clean and sanitary condition and kept in good repair.
e. Each toilet room shall be well lighted and adequately
				  ventilated. Air ventilation ducts from toilet facilities shall vent to the
				  outside.
f. Proper handwashing facilities with hot and cold and/or
				  warm running water shall be provided in toilet rooms.
g. All windows shall be effectively screened when
				  open.
h. Signs shall be posted in all toilet rooms reminding
				  employees to wash their hands before returning to work.
i. Eating and/or storage of food are prohibited in toilet
				  rooms.
7.
WATER SUPPLY
a. The water supply, if from a public system, shall be
				  approved as safe by the applicable Government Authority responsible for water
				  quality, and in the case of individual water systems, comply with at least the
				  specifications outlined in Appendix D. and the bacteriological standards
				  outlined in Appendix G.
b. There shall be no cross-connection between a safe water
				  supply and any unsafe or questionable water supply or any source of pollution
				  through which the safe water supply might become contaminated.
c. Samples for bacteriological testing of individual water
				  supplies are taken upon the initial approval of the physical structure; each
				  twelve (12) months thereafter; and when any repair or alteration of the water
				  supply system has been made. The examination of the sample shall be conducted
				  in an Officially Designated Laboratory.
d. Water baths utilizing re-circulated water for cooling
				  product-contact surfaces shall comply with the bacteriological standards
				  outlined in Appendix G. and shall be tested semi-annually.
e. Records of all required water tests shall be maintained at
				  a location acceptable to the Health Officer for a period of two (2)
				  years.
8.
HANDWASHING FACILITIES
a. Hot and cold and/or warm running water, soap, individual
				  sanitary towels or other approved hand-drying devices shall be convenient to
				  all fabricating areas; provided, that solvent or soft soap dispensers,
				  containing sanitizers, may be used if water is not available. When individual
				  sanitary towels are used, covered trash containers shall be provided.
b. Handwashing facilities shall be kept clean.
9.
PLANT CLEANLINESS
a. The floors, walls, ceilings, overhead beams, fixtures,
				  pipes and ducts of production, storage, regrind, baling and compacting rooms
				  shall be clean.
b. All production areas, warehouse, toilet, lunch and locker
				  rooms shall be free of evidence of insects, rodents, and birds.
c. Machines and appurtenances shall be kept clean; provided,
				  that minor accumulations of paper, plastic, or metal dust and other production
				  soils incidental to normal fabricating operations do not violate this
				  requirement.
10.
LOCKER AND LUNCHROOMS
a. Locker and lunchrooms shall be separate from plant
				  operations and be equipped with self-closing doors.
b. Eating and/or storage of food are prohibited in
				  fabricating and storage areas.
c. Locker and lunchrooms shall be kept in a clean and
				  sanitary condition.
d. Cleanable refuse containers, properly labeled, shall be
				  provided, which are covered, impervious, leak-proof, and readily
				  accessible.
e. Proper handwashing facilities shall be convenient to
				  locker and lunchrooms.
f. Signs shall be posted reminding employees to wash their
				  hands before returning to work.
11.
DISPOSAL OF WASTES
a. All refuse and garbage shall be stored in covered,
				  impervious, and leak-proof containers. This requirement does not pertain to
				  production scrap.
b. All waste containers shall be clearly labeled for their
				  intended purpose and contents.
c. Where possible, garbage and assorted rubbish should be
				  stored outside the building in covered, impervious, cleanable containers. If
				  stored inside the building, it shall be contained in similar receptacles, but
				  in an area separate from fabricating areas.
12.
PERSONNEL - PRACTICES
a. Hands shall be thoroughly washed before commencing plant
				  functions and as often as may be required to remove soil and contamination, and
				  before returning to work after visiting the toilet room or lunchroom.
b. All personnel shall wear clean outer garments and
				  effective hair restraints.
c. No person affected with any disease in a communicable
				  form, or while a carrier of such disease, and no person with an infected cut or
				  lesion shall work in any processing area in any capacity where there is a
				  likelihood of such person contaminating product or product-contact surfaces
				  with pathogenic organisms (refer to
				  420-3-16-.10(16).
d. The use of tobacco products is prohibited in fabricating,
				  regrind, and storage areas.
e. Insecured jewelry shall not be permitted in fabricating
				  areas.
13.
PROTECTION FROM CONTAMINATION
a. All product-contact surfaces of containers, closures, and
				  all materials in process are covered or otherwise protected to prevent the
				  access of insects, dust, condensation, and other contamination.
b. Whenever air under pressure is directed at resin, regrind,
				  colorants, and similar materials or a product-contact surface, it shall be free
				  of oil, dust, rust, excessive moisture, extraneous materials, and odor and
				  shall otherwise comply with the applicable requirements of Appendix H.
c. Air that is directed at product or product-contact
				  surfaces by fans or blowers shall be filtered and shall otherwise comply with
				  the applicable requirements of Appendix H.
d. Only pesticides approved for use in food plants and
				  registered with the EPA shall be used for insect and rodent control.
e. Pesticides shall be used in accordance with the
				  manufacturer's directions and used so as to preclude the contamination of
				  containers or closures.
f. Single-service articles in process shall be protected from
				  contamination by use of a single-service cover sheet or other protective
				  device. This includes chipboard, dividers, separators, bags, and other items
				  that can become contact surfaces.
g. Single-service containers and closures for milk and milk
				  products shall not be fabricated on equipment used for the manufacture of
				  products made of non-food-grade materials, unless such equipment has been
				  thoroughly cleaned and/or purged of all non-food-grade material by a process
				  that will not contaminate the food-grade material.
h. The manufacture of single-service containers and closures
				  for milk and milk products shall be carried on in such a manner that there
				  shall be no cross contamination of raw material or regrind with non-food-grade
				  materials.
i. Equipment and operations are so located within the plant
				  as to prevent overcrowding and allow for cleaning and maintenance
				  procedures.
j. All toxic chemicals, including cleaning and maintenance
				  compounds, shall be adequately segregated from raw materials and finished
				  product.
k. Food containers manufactured by the facility shall not be
				  used for storing miscellaneous items or chemicals.
14.
STORAGE OF MATERIALS AND FINISHED
				  PRODUCT
a. Blanks, roll stock, and all other single-service
				  containers, closures, and articles shall be kept in a clean, dry place until
				  used, stored, and handled in a sanitary manner; and away from any wall a
				  sufficient distance to facilitate inspection, cleaning, and pest control
				  activities. Any roll stock having dirty or soiled outer turns and/or edges
				  shall have sufficient turns discarded prior to use and the edges trimmed to
				  provide protection from contamination.
b. Appropriate clean, dry storage facilities shall be
				  provided for single-service containers, closures, paper for wrapping,
				  adhesives, blanks, and other production material to provide protection from
				  splash, insects, dust, and other contamination.
c. Where containers and closures are pre-formed in plants
				  other than the original fabricating facility:
(1) Containers, blanks, and closures shall be stored in the
				  original cartons and sealed until used.
(2) Partially used cartons of containers, blanks, and
				  closures shall be re-sealed until used.
d. Containers used for the storage of resin and other raw
				  materials, regrind, broke and trim, intended for use in the process, shall be
				  covered, clean, impervious, and properly identified. Reuse of storage
				  containers such as gaylords is permitted provided single-use plastic liners are
				  used.
e. In-process storage bins that touch the product-contact
				  surface of containers or closures shall be constructed of cleanable,
				  nonabsorbent material and kept clean.
15.
FABRICATING EQUIPMENT
The requirements of this section pertain to all equipment and
				  processes used in the fabrication of containers and closures, irrespective of
				  the materials used and whether or not mentioned herein. Some of this equipment
				  includes grinders, rollers, reamers and cutters, molders and fittings,
				  extruders, silos, resin bins and hoppers, printing equipment, blanking
				  equipment, and sealing equipment.
a. Rolls, dies, belts, tables, mandrels, transfer tubing, and
				  all other contact surfaces shall be kept clean, sanitary and reasonably free of
				  accumulation of paper, plastic, or metal dust and other production soils.
				  Equipment designed for milk plant use which is utilized for pre-forming
				  containers shall be clean and sanitized prior to operation.
b. Makeshift devices such as tape, rope, twine, paperboards,
				  etc., shall not be used. All fasteners, guides, hangers, supports, and baffles
				  shall be constructed of impervious, cleanable materials and kept in good
				  repair.
c. Take-off tables and other container-contact surfaces shall
				  be constructed of cleanable material, kept clean, and in good repair.
d. All grinders, shredders, and similar equipment used for
				  regrinding shall be installed above the floor or installed in such a manner
				  that they are protected so that floor sweepings and other contaminants cannot
				  enter the grinder or shredder.
e. Storage tanks, silos, gaylords, or bins used for plastic
				  resins shall be so constructed to protect the resin from contamination. All air
				  vents shall be filtered to prevent the entrance of dust, dirt, or insects. Air
				  tubes used to convey resin shall be in good repair and installed in such a
				  manner that protects the resin from contamination. Air tubes used to convey
				  resin shall have end caps attached by a chain or cable that prevents
				  contamination. This item also applies to all raw materials handled in like
				  manner.
16.
MATERIALS FOR CONSTRUCTION OF CONTAINERS AND
				  CLOSURES
a. Only resin in compliance with 21 CFR Parts 174-178 shall
				  be used for the construction of containers and/or closures. Only plastic
				  sheeting and extrusions, plastic laminated paper, roll stock, component
				  part(s), molded or formed parts, metal and paperboard blanks, or combinations
				  thereof, from a manufacturing and/or fabricating plant conforming to these
				  standards, shall be used. Fabricating plants listed in the current
IMS
				  List
shall be considered in compliance with this item.
b. Only food-grade, non-toxic lubricants shall be used on
				  container or closure-contact surfaces. Excess lubricant shall be removed from
				  surfaces close to shafts, rollers, bearing sleeves, and mandrels. These
				  lubricants shall be handled and stored in a manner that shall prevent cross
				  contamination with non-food-grade lubricants. Such storage areas shall be clean
				  and adequately ventilated.
c. Containers, resin, and flashing on the floor, and floor
				  sweepings of production materials and production scrap are prohibited from
				  being reused. This shall not preclude the use of these materials when they
				  comply with a recycling protocol that has been reviewed and accepted by
				  FDA.
17.
WAXES, ADHESIVES, SEALANTS, COATINGS, AND
				  INKS
a. Waxes, adhesives, sealants, coatings, and inks used for
				  containers and closures shall be handled and stored in a manner that shall
				  prevent cross contamination with similar non-food- grade materials. Such
				  storage areas shall be clean and adequately ventilated.
b. Unused materials shall be covered, labeled, and properly
				  stored.
c. Waxes, adhesives, sealants, coatings, and inks shall not
				  impart odor or taste to the milk or milk products and shall not contaminate the
				  product with microorganisms or toxic or injurious substances. All materials
				  that are applied to the product-contact surface shall comply with the
				  requirements of 21 CFR Parts 174-178.
d. Transfer containers shall be kept clean and shall be
				  properly identified and covered.
e. Waxing shall be performed so as to assure that containers
				  or closures are completely coated and the wax shall be kept at a temperature of
				  60°C (140°F) or higher.
18.
HANDLING OF CONTAINERS AND EQUIPMENT
a. Handling container and closure surfaces shall be kept to a
				  minimum.
b. Handlers shall sanitize their hands frequently or wear
				  clean, single-use gloves. Hand sanitizing dispensers, if used, shall be located
				  convenient to all operations involving manual contact.
19.
WRAPPING AND SHIPPING
a. Blanks, closures, halves, nested or pre-formed containers,
				  and parts such as valves, hoses, tubes, and other fittings shall be properly
				  packaged or containerized prior to shipping.
b. The outer package or containerized units shall protect the
				  contents from dust and other contamination.
c. Transportation vehicles used to ship finished materials
				  from the single-service container or closure plant or within the plant shall be
				  clean and in good repair and shall not have been used for the transportation of
				  garbage, waste, or toxic materials.
d. Paperboard containers, wrappers, and dividers that contact
				  the surface of the container or closure shall not be reused for this
				  purpose.
e. All packaging materials that contact the product-contact
				  surface of the container or closure shall comply with the requirements of 21
				  CFR Parts 174-178 and the bacteriological standards of Section C of this
				  appendix, but the materials do not have to be manufactured at a listed
				  single-service plant. Some outer packaging material such as corrugated
				  cardboard boxes used for the packaging of milk carton flats are exempt from
				  this bacteriological standard. The edges of these flats are subject to heat
				  during the forming and sealing of the container.
20.
IDENTIFICATION AND RECORDS
a. Outer wrappings shall be identified with the name and city
				  of the plant where the contents are fabricated, except those manufactured in,
				  and which are only for use in the same facility. Where several plants are
				  operated by one (1) firm, the common firm name may be utilized, provided that
				  the location of the plant at which the contents were fabricated is also shown
				  either directly or by the Federal Information Processing Standards (FIPS)
				  numerical code on the outer wrapper.
b. Single-service glass containers shall be labeled with
				  wording to designate "single-service use only."
c. Records of all required bacteriological tests of
				  containers and closures shall be maintained at the plant of manufacture for two
				  (2) years and results shall be in compliance with Section C.
d. It is the responsibility of the inspected/certified and
				  listed plant to maintain records verifying the bacterial and chemical safety of
				  all component parts utilized in the final assembled product.
e. The fabricating plant shall have on file information from
				  suppliers of raw material, waxes, adhesives, sealants, coatings, and inks
				  indicating that the material complies with the requirements of 21 CFR Parts
				  174-178.
f. The fabricating plant shall have on file information from
				  the suppliers of packaging materials specified in Section 19e of these
				  Standards indicating that the material complies with the requirements of 21 CFR
				  Parts 174-178 and the bacteriological standards of Section C. There are no
				  specifications for sampling frequency. The Health Officer may choose to collect
				  samples of packaging materials to determine compliance with bacteriological
				  standards of this section.
g. Multi-plant corporations may have all the required
				  information at a central location as long as it can be transmitted to the site
				  upon request.
21.
SURROUNDINGS
a. Exterior surroundings shall be neat and clean and free
				  from conditions that might attract or harbor flies, other insects, and
				  rodents.
b. Driveways, lanes, and areas serving the plant vehicular
				  traffic are graded, drained, and free from pools of standing water.
E.
CRITERIA FOR LISTING CERTIFIED SINGLE-SERVICE
				  MANUFACTURERS ON THE IMS LIST
The following criteria have been developed to allow the
				  Health Officer's flexibility in evaluating and listing single-service
				  manufacturing plants. The Health Officer may choose from the following list of
				  criteria for listing certified single-service manufacturers:
1. Single-service manufacturers that operate in conjunction
				  with an IMS Listed milk plant may be listed for twenty-four (24) months if the
				  single-service plant is inspected at least quarterly using the ADPH-FML-229
				  Form (Alabama Department of Public Health Manufacturing Plant Inspection Report
				  Single-Service Containers) and records of such inspections and all required
				  tests are maintained by the Health Officer; provided that, single-service
				  manufacturers that operate in conjunction with an IMS HACCP listed milk plant
				  may be listed for twenty-four (24) months if the single-service plant is
				  integrated into the milk plant's NCIMS HACCP system and if the single-service
				  plant is inspected at the minimum milk plant audit frequency specified in
				  Appendix K, using the ADPH-FML-229 Form (Alabama Department of Public Health
				  Manufacturing Plant Inspection Report Single-Service Containers) and records of
				  such inspections and all required tests are maintained by the Health Officer.
				  The permit for the milk plant shall also include the inspection of the
				  single-service manufacturing areas.
2. Single-service manufacturers that operate in conjunction
				  with an IMS listed milk plant and are not inspected at least quarterly and/or
				  are not included under a permit system may be optionally listed for twelve (12)
				  months.
3. Single-service manufacturers that operate as a separate
				  entity may be listed for twenty-four (24) months if the Health Officer has a
				  permit system and inspects the plant using the ADPH-FML-229 Form (Alabama
				  Department of Public Health Manufacturing Plant Inspection Report
				  Single-Service Containers) at least quarterly. All testing of containers and
				  individual water supplies shall be under the direction of the Health Officer
				  and kept on file.
4. Single-service manufacturers that operate as a separate
				  entity and are not inspected by the Health Officer at least quarterly and/or do
				  not have a permit system may be optionally listed for twelve (12)
				  months.
5. Certification of single-service manufacturing plants may
				  be valid for a period not to exceed one (1) or two (2) years from the earliest
				  survey date, based on the criteria above. The expiration date is one (1) or two
				  (2) years from the earliest survey date. In the case of a one (1) year
				  certification with the earliest survey date of June 15, 2013, the expiration
				  date would be June 14, 2014.
The following procedures shall be followed for listing
				  certified single-service manufacturers on the IMS List:
1. For domestic firms: triplicate copies or USPHS/FDA's
				  electronic version (transmitted via computer) of FORM FDA 2359d-REPORT OF
				  CERTIFICATION
(Fabrication of Single-Service Containers and Closures
				  for Milk and Milk Products)
shall be submitted by the SRO to the
				  appropriate Regional Office of the USPHS/FDA for single-service manufacturers
				  who desire to be listed on the IMS List.
2. For foreign firms: duplicate copies or USUSPHS/FDA's
				  electronic version (transmitted via computer) of FORM FDA 2359d-REPORT OF
				  CERTIFICATION
(Fabrication of Single-Service Containers and Closures
				  for Milk and Milk Products)
shall be submitted by the TPC or private
				  consultant conducting the certification to CFSAN's Milk Safety Team (HFS-316),
				  Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD
				  20740-3835 for single-service manufacturers who desire to be listed on the IMS
				  List.
3. The Certified Single-Service Manufacturer is not listed on
				  the IMS List unless the "PERMISSION TO PUBLISH" SECTION of FORM FDA 2359d is
				  signed by an officer of the firm authorizing the release.
a. For the submission of USPHS/FDA's electronic version, a
				  signed copy of FORM FDA 2359d, including Section 12, shall be maintained on
				  file by the Rating Agency and shall be reviewed as part of the Single-Service
				  Listing Audit and/or the Regulatory/Rating Agency Program Evaluation.
b. For the submission of USPHS/FDA's electronic version, a
				  signed copy of FORM FDA 2359d, including Section 12, shall be maintained on
				  file by the private consulting firm.
4. The Certified Single-Service Manufacturer may be listed on
				  the IMS List as a "PARTIAL" listing. A "PARTIAL" listing shall mean that only
				  specific production rooms or fabrication lines or machines have been evaluated
				  in regard to specific containers or closures or specific size of containers or
				  closures and conform to the specifications contained within Appendix
				  J.
Author:
G. M. Gallaspy, Jr.
Statutory Authority:
Code of Ala. 1975,
					 §§
											22-2-2,
					 22-20-7.