902 KAR 45:160. Kentucky food processing, packaging, storage, and
distribution operations.
RELATES
TO: KRS 13B, 194A.050, 211.090, 211.180, 217.005 - 217.205, 217.290 - 217.390,
217.990 - 217.992, 318.130, 21 C.F.R. Part 1, 7, 70, 73, 74, 81, 82, 100 - 102,
104 - 107, 108.25, 108.35, 109, 110, 113, 114, 120, 123, 129, 130, 133, 135 -
137, 139, 145, 146, 150, 152, 155, 156, 158, 160, 161, 163 - 166, 168, 169,
170, 172 - 178, 180 - 189, Pub. L. 101 - 535, Pub. L. 108 - 282, 21 U.S.C. 373
STATUTORY
AUTHORITY: KRS 194A.050(1), 211.090(3), 211.180(1), 217.125(1)
NECESSITY,
FUNCTION, AND CONFORMITY: KRS 194A.050(1) and 217.125(1) authorize the Cabinet
for Health and Family Services to promulgate administrative regulations to regulate
food processing, packaging, storage, and distribution operations. This
administrative regulation establishes procedures and requirements for food
processing, packaging, storage, and distribution operations for the purpose of
protecting public health.
Section
1. Definitions. (1) "Adulterated" is defined by KRS 217.025. (2) "Cabinet"
is defined by KRS 194A.005(1).
(3)
"Food processing establishment" is defined by KRS 217.015(20).
(4)
"Food storage warehouse" is defined by KRS 217.015(22).
(5)
"Imminent health hazard" is defined by KRS 217.015(24). (6) "Misbranded"
is defined by KRS 217.035.
(7)
"No Action Indicated" or "NAI" means a plant inspection
classification which indicates the firm has no violating condition or that only
a minor violation was noted at the time of inspection.
(8)
"Official Action Indicated" or "OAI" means a plant inspection
classification which indicates a condition noted during the inspection was
significant enough to pose an imminent health hazard, or was an uncorrected VAI
condition on a previous inspection.
(9)
"Plant" means a food processing establishment or a food storage
warehouse.
(10)
"State Plumbing Code" means the code established by KRS Chapter 318
and 815 KAR Chapter 20.
(11)
"Voluntary Action Indicated" or "VAI" means a plant inspection
classification which indicates that a condition was noted during the inspection
that is in violation of this administrative regulation but was not significant
enough to pose an imminent health hazard.
Section
2. Applicability. (1) A plant shall comply with the following federal
requirements:
(a)
21 U.S.C. 373, Records;
(b)
21 C.F.R. 1.20 - 1.24, General labeling requirements;
(c)
21 C.F.R. 7.1 - 7.13, General enforcement policy provisions;
(d)
21 C.F.R. 7.40 - 7.59, Food recalls provisions;
(e)
21 C.F.R. 70.20 - 70.25, Packaging and labeling requirements;
(f)
21 C.F.R. 73.1 - 73.615, Listing of food color additives exempt from
certification;
(g)
21 C.F.R. 74.101 - 74.706, Listing of food color additives subject to
certification;
(h)
21 C.F.R. Part 81, General specifications and general restrictions for
provisional color additives for use in foods, drugs, and cosmetics;
(i)
21 C.F.R. 82.3 - 82.706, Listing of certified provisionally listed food colors
and specifications;
(j)
21 C.F.R. 100.155, Salt and iodized salt;
(k)
21 C.F.R. Part 101, Food Labeling;
(l)
21 C.F.R. Part 102, Common or usual name for non-standardized foods;
(m)
21 C.F.R. Part 104, Nutritional quality guidelines for foods;
(n)
21 C.F.R. Part 105, Foods for special dietary use;
(o)
21 C.F.R. Part 106, Infant formula quality control procedures;
(p)
21 C.F.R. Part 107, Infant formula;
(q)
21 C.F.R. 108.25, Specific requirements and conditions for exemption from or
compliance with an emergency permit;
(r)
21 C.F.R. 108.35, Thermal processing of low-acid foods packaged in hermetically
sealed containers;
(s)
21 C.F.R. Part 109, Unavoidable contaminants in food for human consumption and
food packaging materials;
(t)
21 C.F.R. Part 110, Current good manufacturing practice in manufacturing,
packaging and holding human food, whether sold interstate or intrastate
commerce;
(u)
21 C.F.R. Part 113, Low acid foods;
(v)
21 C.F.R. Part 114, Acidified foods;
(w)
21 C.F.R. Part 120, Hazard analysis and critical control point (HACCP) systems;
(x)
21 C.F.R. Part 123, Fish and fishery products
(y)
21 C.F.R. Part 129, Processing and bottling of bottled drinking water;
(z)
21 C.F.R. Part 130, Food standards general;
(aa)
21 C.F.R. 133.10, 133.124, 133.125, 133.167 – 133.169, 133.171, 133.173 – 133.176,
133.179 - 133.180, Cheeses and related cheese products;
(bb)
21 C.F.R. Part 135, Frozen desserts;
(cc)
21 C.F.R. Part 136, Bakery products;
(dd)
21 C.F.R. Part 137, Cereal flours and related products;
(ee)
21 C.F.R. Part 139, Macaroni and noodle products;
(ff)
21 C.F.R. Part 145, Canned fruits;
(gg)
21 C.F.R. Part 146, Canned fruit juices;
(hh)
21 C.F.R. Part 150, Fruit butters, jellies, preserves, and related products;
(ii)
21 C.F.R. Part 152, Fruit pies;
(jj)
21 C.F.R. Part 155, Canned vegetables;
(kk)
21 C.F.R. Part 156, Vegetable juices;
(ll)
21 C.F.R. Part 158, Frozen vegetables;
(mm)
21 C.F.R. Part 160, Eggs and egg product;
(nn)
21 C.F.R. Part 161, Fish and shellfish;
(oo)
21 C.F.R. Part 163, Cacao products;
(pp)
21 C.F.R. Part 164, Tree nut and peanut products;
(qq)
21 C.F.R. Part 165, Beverages;
(rr)
21 C.F.R. Part 166, Margarine;
(ss)
21 C.F.R. Part 168, Sweeteners and table syrups;
(tt)
21 C.F.R. Part 169, Food dressings and flavorings;
(uu)
21 C.F.R. Part 170, Food additives;
(vv)
21 C.F.R. Part 172, Food additives permitted for direct addition to
food for human consumption;
(ww)
21 C.F.R. Part 173, Secondary direct food additives permitted in food
for human consumption;
(xx)
21 C.F.R. Part 174, Indirect food additives: general;
(yy)
21 C.F.R. Part 175, Indirect food additives: adhesives and components
of coatings;
(zz)
21 C.F.R. Part 176, Indirect food additives: paper and paperboard
components;
(aaa)
21 C.F.R. Part 177, Indirect food additives: polymers;
(bbb)
21 C.F.R. Part 178, Indirect food additives: adjuvants, production
aids, and sanitizers;
(ccc)
21 C.F.R. Part 180, Food additives permitted in food or in contact
with food on an interim basis pending additional study;
(ddd)
21 C.F.R. Part 181, Prior sanctioned food ingredients;
(eee)
21 C.F.R. Part 182, Substances generally recognized as safe;
(fff)
21 C.F.R. Part 184, Direct food substances affirmed as generally
recognized as safe;
(ggg)
21 C.F.R. Part 186, Indirect food substances affirmed as generally
recognized as safe;
(hhh)
21 C.F.R. Part 189, Substances prohibited from use in human food;
(iii)
Pub. L. 101 - 535, Nutritional labeling and educational act; and
(jjj)
Pub. L. 108 - 282, Food allergen labeling and consumer protection act.
(2) The following federal regulations shall not apply:
(a)
21 C.F.R. 101.69;
(b)
21 C.F.R. 101.108;
(c)
21 C.F.R. 102.19;
(d)
21 C.F.R. 106.120;
(e)
21 C.F.R. 107.200 - 107.280;
(f)
21 C.F.R. 120.14;
(g)
21 C.F.R. 123.12;
(h)
21 C.F.R. 130.5 - 130.6;
(i)
21 C.F.R. 130.17;
(j)
21 C.F.R. 170.6;
(k)
21 C.F.R. 170.15; and
(l)
21 C.F.R. 170.17.
Section
3. Permits. (1) Before operating, a food manufacturing or processing plant,
food packaging plant, food storage warehouse, or food distribution warehouse
shall obtain a permit from the cabinet in accordance with KRS 217.125.
(2)
Application for a permit shall be made on Form DFS-260, Application for Permit
to Operate a Food Plant, and shall be submitted to the cabinet with the annual
fee established by 902 KAR 45:110.
(3)
A permit for food manufacturing, food packaging, food storage, or food
distribution shall only be issued:
(a)
In the name of the applicant;
(b)
For the location identified in the application; and
(c)
For a firm that is in compliance with this administrative regulation and KRS
217.005 - 217.215.
(4)
A permit shall:
(a)
Be posted in a conspicuous place in the firm;
(b)
Expire on December 31 of each year; and
(c)
Be renewed in accordance with KRS 217.125(12) and by submitting the form and fee
required by subsection (2) of this section.
(5)
Failure to apply for or renew a permit to operate a food processing, packaging,
storage, or distribution plant shall result in the cabinet issuing a Notice to
Cease Operation.
Section
4. Plan Review. (1) Approval shall be obtained from the cabinet or its local
health department agent prior to beginning work, if:
(a)
A plant is constructed, remodeled, or altered;
(b)
A plant’s plumbing is relocated;
(c)
Additional plumbing is added to a plant; or
(d)
An existing structure is converted for use as a plant.
(2)
To obtain approval, an applicant shall submit plans and specifications for the
construction, remodeling, or alteration to the local health department in the
county in which the construction, remodeling, or alteration will take place.
(3)
Plans shall be prepared to show: (a) Equipment layout;
(b)
Size;
(c)
Location and type of facilities; and
(d)
Plumbing riser diagram.
Section
5. Construction and Maintenance. (1) The floor of the food preparation, food
storage, and utensil washing area, walk-in refrigerator, dressing room, locker
room, toilet room, and vestibule shall be:
(a)
Smooth;
(b)
Durable;
(c)
Non-absorbent; and
(d)
Easily cleaned.
(2)
Floors shall be cleaned and maintained.
(3)
A juncture of a wall with a floor shall be covered and sealed.
(4)
The juncture between the wall and floor shall be tight-fitting.
(5)(a)
A floor drain shall be provided in a floor that is water flushed for cleaning
or that receives discharge of water or other fluid waste from equipment.
(b)
Floors shall be graded to drain all parts of the floor.
(6)
Drip or condensate from fixtures, ducts, and pipes shall not contaminate food,
food-contact surfaces, or food-packaging materials.
(7)
Mats shall be:
(a)
Non-absorbent;
(b)
Slip resistant; and
(c)
Easily cleaned.
(8)
Mats shall not be used as storage racks.
(9)
Exposed utility service lines and pipes shall be installed to prevent tripping
hazards and cleaning obstructions.
(10)
Walls and ceilings, including doors, windows, skylights, and similar closures,
shall be maintained in good repair.
(11)
Walls and ceilings of all food preparation and ware washing areas shall be:
(a)
Smooth;
(b)
Non-absorbent; and
(c)
Easily cleaned.
(12)
Studs, joists, and rafters shall not be exposed in:
(a)
Walk-in-refrigerators;
(b)
Food preparation areas; and
(c)
Ware washing areas.
(13)
Doors shall be:
(a)
Solid;
(b)
Tight-fitting; and
(c)
Closed, except during cleaning or maintenance.
(14)
Light fixtures, vent covers, wall-mounted fans, and similar equipment attached
to walls and ceilings shall be kept clean and maintained in good repair.
(15)
Aisles and working spaces shall be:
(a)
Unobstructed; and
(b)
Of a width to permit employees to perform their duties and protect against
contaminating food or food-contact surfaces with clothing or by personal
contact.
(16)
Lighting shall be provided in:
(a)
Hand-washing areas;
(b)
Dressing and locker rooms;
(c)
Toilet rooms;
(d)
Areas where food is examined, processed, or stored; and
(e)
Areas where equipment or utensils are cleaned.
(17)
Lighting, glass fixtures, and skylights suspended over exposed food or food
packaging materials shall be made of safety glass or otherwise shielded to
protect against food contamination in case of breakage.
(18)
Ventilation or exhaust control equipment shall be provided to minimize odors
or
vapors in areas where odors or vapors may contaminate food.
(19)
Fans and other air-blowing equipment shall be located and operated in a manner
that minimizes the potential for contaminating food, food-packaging materials,
and food-contact surfaces.
(20)
Protection against pests shall be provided.
Section
6. Water Supply. (1) The water supply shall be:
(a)
Potable;
(b)
Of sufficient quantity to meet plant needs; and
(c)
From an approved public water system, if available.
(2)
If a public water system is not available, the supply for the plant shall be
approved pursuant to 401 KAR Chapters 8 and 11.
(3)
If a community public water system later becomes available and has the capacity
to serve the facility, connections may be made to it. The non-community water
supply shall then be discontinued and inactivated.
(4)
Hot and cold running water under pressure shall be provided in all areas where
it is needed for:
(a)
Processing food;
(b)
Cleaning equipment, utensils, and food-packaging materials; and
(c)
Employee sanitary facilities.
(5)
Bottled water plants shall have their water supply system designed, approved,
and operated in accordance with 401 KAR 8:700.
Section
7. Plumbing. (1) All plumbing shall comply with the minimum fixture
requirements, and be sized, installed, and maintained in accordance with the
State Plumbing Code.
(2)
All utensils used in food processing that are not a part of a clean-in-place
operation shall be washed, rinsed, and sanitized in:
(a)
A permanently plumbed three (3) compartment sink; or
(b)
A commercial dishwasher installed and operated in compliance with the State Plumbing
Code and the manufacturer’s instructions.
(3)
If a three (3) compartment sink is utilized, the sink compartments shall be
large enough to permit the accommodation of the equipment and utensils and each
compartment of the sink shall be supplied with hot and cold potable running
water under pressure.
(4)
Clean-in-place equipment shall be cleaned or sanitized according to
manufacturer instructions and industry best practices for the commodity being
processed.
(5)
Written sanitation procedures shall be maintained for each type of clean-in-place
equipment.
(6)
A service sink or curbed cleaning facility with a drain that allows for
disposal of mop and cleaning solution water shall be provided.
(7)
A person, firm, or corporation shall not construct, install, or alter any
plumbing without having procured a plumbing construction permit from the
Department of Housing, Buildings and Construction, under KRS Chapter 318.
Section
8. Sewage Disposal. (1) All sewage shall be disposed of into a public sewerage
system, if available.
(2)
If a public sewerage system is not available, disposal shall be made into a
private system designed, constructed, and operated pursuant to the requirements
of 401 KAR Chapter 5 or 902 KAR 10:085.
(3)
If a public sewerage system becomes available, connection shall be made and the
private sewerage system shall be discontinued.
Section
9. Toilet Facilities. Toilet facilities shall meet the fixture and construction
requirements of KRS Chapter 318 and the State Plumbing Code.
Section
10. Hand Washing Facilities. (1) Hand-washing facilities shall be installed in
accordance with KRS Chapter 318 and the State Plumbing Code where:
(a)
Food is prepared;
(b)
Utensils are washed; and
(c)
Sanitary practices require employees to wash and sanitize their hands.
(2)
All hand washing facilities shall be provided with:
(a)
Soap;
(b)
Disposable hand drying towels or mechanical hand drying devices; and
(c)
Non-absorbent waste receptacles.
(3)
Hand sanitizer shall not be used in lieu of hand washing.
(4)
Lavatories used for hand washing shall not be used for food preparation or for
washing equipment or utensils.
(5)
Lavatories, soap dispensers, and hand drying devices shall be kept clean and
maintained.
Section
11. Food Transportation. (1) Vehicles used for the transportation of food shall
be maintained and loaded in a manner to prevent cross-contamination of food.
(2)
Vehicles that transport refrigerated food shall be capable of maintaining
frozen food frozen and refrigerated foods at forty-five (45) degrees Fahrenheit
or below.
Section
12. Inspection Frequencies. (1) The cabinet shall assign an inspection
frequency to each food manufacturing plant based upon the degree of risk associated
with the commodity processed, packaged, stored, or distributed by the plant.
(2)
The cabinet shall assign the inspection frequencies as follows:
(a)
High risk plants shall be inspected no less than once every 360 days;
(b)
Medium risk plants shall be inspected no less than once every 720 days; and
(c)
Low risk plants shall be inspected no less than once every 1,080 days.
(3)
The cabinet shall conduct additional inspections as necessary for enforcement pursuant
to this administrative regulation.
Section
13. Violations. (1) If a plant has committed a violation of this administrative
regulation, an opportunity to correct the violation shall be provided in
accordance with the following classifications:
(a)
NAI - No changes in the inspection frequency are warranted under this
classification;
(b)
VAI - A follow-up inspection is warranted within a period of time not to exceed
ninety (90) days to determine if the violation causing this classification has
been corrected; or
(c)
OAI - A follow-up inspection shall be conducted within a period of time not to
exceed forty-five (45) days to determine if the violation causing the
classification has been corrected. A plant may also be classified as OAI if it
continually fails to correct a violation previously classified under a VAI
designation or if an imminent health hazard is noted during an inspection.
(2)
Upon completion of the inspection, a recommended classification of NAI, VAI, or
OAI and the timeframe for correction of the violation shall be specified on
DFS-220, Food Plant Inspection Report.
(3)
If, during a follow-up inspection, the violation noted on the previous
inspection has not been corrected within the timeframe specified by the
cabinet, the cabinet shall:
(a)
Extend the timeframe for corrective action if the cabinet determines that
progress towards compliance has been made; or
(b)
Initiate enforcement provisions pursuant to Section 17 of this administrative
regulation.
Section
14. Food Plant Environmental Sampling. The cabinet shall collect an environmental
sample in an area of the plant as necessary for the enforcement of this administrative
regulation.
Section
15. Examination and Detention of Foods. (1) The cabinet shall examine and
collect samples of food as often as necessary for the enforcement of this
administrative regulation.
(2)
When food is deemed to be adulterated or misbranded, DFS-265, Food Plant
Quarantine/Final Disposition Report, shall be issued to the permit holder or
person in charge pursuant to KRS 217.115.
Section
16. Imminent Health Hazard and Notification Requirements. (1) The permit holder
shall take immediate steps to correct conditions which have caused an imminent
health hazard.
(2)(a)
The permit holder shall notify the cabinet within twenty-four (24) hours of the
knowledge of an imminent health hazard that cannot be controlled by immediate
corrective action or if food, food contact equipment, or food packaging has
become contaminated because of an imminent health hazard.
(b)
Written notification to the cabinet shall be made by:
1.
Email to CHFSDPHENV@KY.gov; or
2.
Fax to 502-696-1882.
(3)
If the cabinet has evidence that a plant has failed to act to correct an
imminent health hazard, enforcement provisions shall be initiated pursuant to
Section 17 of this administrative regulation.
Section
17. Enforcement Provisions. (1) If the cabinet has substantial reason to
believe that a permit holder has failed to act to correct an imminent health
hazard or if the permit holder or an authorized agent has interfered with the
cabinet in the performance of its duties after its agents have duly and
officially identified themselves, the cabinet shall immediately, upon notice to
the permit holder using the DFS-263, Food Plant Enforcement Notice:
(a)
Suspend the permit without a conference; or
(b)
Suspend that portion of the plant operation affected by the imminent health
hazard without a conference.
(2)
In the instance of a permit suspension due to an imminent health hazard, the
permit holder may request a conference on a DFS-267, Request for Conference. A
conference shall be granted as soon as practical, not to exceed seven (7) days
from the receipt of the Request for Conference.
(3)
In all other instances of violation of this administrative regulation, the
cabinet shall serve the permit holder with a written notice specifying the
violation and afford the holder an opportunity to correct.
(4)
If a permit holder or operator has failed to comply with an OAI inspection notice
within the timeframe granted, the cabinet shall issue a Notice of Intent to
Suspend Permit on a DFS-263, Food Plant Enforcement Notice.
(5)
When a Notice of Intent to Suspend Permit is issued, the permit holder or
operator shall be notified in writing that the permit shall be suspended at the
end of ten (10) days following service of the notice, unless a written request
for a conference is filed with the cabinet by the permit holder within the ten
(10) day period.
(6)
Any person whose permit has been suspended may make application on Form DFS-269,
Application for Reinstatement, for a re-inspection for the purpose of reinstatement
of the permit. Within seven (7) days following receipt of a written request,
including a statement signed by the applicant that in his opinion the condition
causing suspension of the permit has been corrected, the cabinet shall make an
inspection, and if the inspection reveals that the condition causing suspension
of the permit has been corrected, the permit shall be reinstated.
(7)
For a plant that has had a suspended permit two (2) or more times within a five
(5) year period, the cabinet shall initiate permit revocation proceedings. Prior
to this action, the cabinet shall notify the permit holder in writing on a DFS-263,
Food Plant Enforcement Notice, stating the reasons for which the permit
revocation is being sought and advising that the permit shall be permanently
revoked at the end of ten (10) days following service of the notice, unless a request
for an administrative hearing is filed with the cabinet pursuant to KRS Chapter
13B by the permit holder within the ten (10) day period.
(8)
Notice provided for under this administrative regulation shall be deemed to
have been properly served if:
(a)
A copy of the inspection report or other notice has been delivered personally
to the permit holder; or
(b)
The notice has been sent by registered or certified mail, return receipt.
Section
18. Administrative Conferences. An administrative conference shall be conducted
pursuant to 902 KAR 1:400.
Section
19. Administrative Hearings. An administrative hearing shall be conducted pursuant
to KRS Chapter 13B.
Section
20. Incorporation by Reference. (1) The following material is incorporated by
reference:
(a)
"DFS-220, Food Plant Inspection Report", 09/2014;
(b)
"DFS-260, Application for Permit to Operate a Food Plant", 09/2014;
(c)
"DFS-263, Food Plant Enforcement Notice," 09/2014;
(d)
"DFS-265, Food Plant Quarantine/Final Disposition Report", 09/2014;
(e)
"DFS-267, Request for Conference", 09/2014; and
(f)
"DFS-269, Application for Reinstatement", 09/2014.
(2)
This material may be inspected, copied, or obtained, subject to applicable copyright
law, at Cabinet for Health and Family Services, Department for Public Health, Division
of Public Health Protection and Safety, Food Safety Branch, 275 East Main Street,
Frankfort, Kentucky 40602, Monday through Friday, 8 a.m. to 4:30 p.m. (41 Ky.R.
2470; Am. 42 Ky.R. 321; eff. 9-4-2015.)
