[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR303.1]
[Page 90-97]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 303_EXEMPTIONS--Table of Contents
Sec. 303.1 Exemptions.
(a) The requirements of the Act and the regulations in this
subchapter for inspection of the preparation of products do not apply
to:
(1) The slaughtering by any individual of livestock of his own
raising, and the preparation by him and transportation in commerce of
the carcasses, parts thereof, meat and meat food products of such
livestock exclusively for use by him and members of his household and
his nonpaying guests and employees;
(2) The custom slaughter by any person of cattle, sheep, swine, or
goats delivered by the owner thereof for such slaughter, and the
preparation by such slaughterer and transportation in commerce of the
carcasses, parts thereof, meat and meat food products of such livestock,
exclusively for use, in the household of such owner, by him and members
of his household and his nonpaying guests and employees; nor to the
custom preparation by any person of carcasses, parts thereof, meat or
meat food products derived from the slaughter by any individual of
cattle, sheep, swine, or goats of his own raising or from game animals,
delivered by the owner thereof for such custom preparation, and
transportation in commerce of such custom prepared articles, exclusively
for use in the household of such owner, by him and members of his
household and his nonpaying guests and employees: Provided, That the
following requirements are met by such custom operator;
(i) Establishments that conduct custom operations must be maintained
and operated in accordance with the provisions of Sec. Sec. 416.1
through 416.6, except for: Sec. 416.2(g)(2) through (6) of this
chapter, regarding water reuse and any provisions of part 416 of this
chapter relating to inspection or supervision of specified activities or
other action by a Program employee. If custom operations are conducted
in an official establishment, however, all of the provisions of Part 416
of this chapter of shall apply to those operations.
(ii) If the custom operator prepares or handles any products for
sale, they are kept separate and apart from the custom prepared products
at all times while the latter are in his custody;
(iii) The custom prepared products are plainly marked ``Not for
Sale'' as provided in Sec. 316.16 of this subchapter, immediately after
being prepared and are kept so identified until delivered to the owner;
and
(iv) If exempted custom slaughtering or other preparation of
products is conducted in an official establishment, all facilities and
equipment in the official establishment used for such custom operations
shall be thoroughly cleaned and sanitized before they are used for
preparing any products for sale.
(b)(1) The exempted custom prepared products shall be prepared and
handled in accordance with the provisions of Sec. Sec. 318.5, 318.6,
318.7, 318.10, and 318.300 through 318.311 of this subchapter and shall
not be adulterated as defined in paragraph 1(m) of the Act: Provided,
That the provisions of Sec. Sec. 318.5, 318.6, 318.10, and 318.300
through 318.311 relating to inspection or supervision of specified
activities or other action by a Program inspector, and the provisions of
Sec. 318.6(b)(9) and (10), shall not apply to the preparation and
handling of such exempted products.
(2) The exempted custom prepared products shall comply with the
requirements of Sec. Sec. 316.16 and 317.16 of this subchapter.
(3) The custom operators claiming exemption under paragraph (a)(2)
of this section shall keep records, in addition to records otherwise
required by part 320 of this subchapter, showing the numbers and kinds
of livestock slaughtered on a custom basis, the quantities and types of
products prepared on a custom basis, and the names and addresses of the
owners of the livestock and products.
[[Page 91]]
(4) Articles capable of use as human food, resulting from the
exempted custom slaughter or other preparation of products shall be
promptly denatured or otherwise identified in accordance with Sec.
325.13 of this subchapter and not removed from the establishment where
the custom operations are conducted until so identified, unless they are
delivered to the owner of the articles for use in accordance with
paragraph (a)(2) of this section.
(c) It has been determined that it is impracticable to provide
inspection of the preparation of products at establishments in any
unorganized Territory at which livestock are slaughtered or their
products are prepared for distribution solely within such jurisdiction
and that exempting such establishments from requirements of the Act for
such inspections under the conditions stated in this section will
otherwise facilitate enforcement of the Act. Therefore, such inspection
requirements of the Act and of the regulations in this subchapter shall
not apply at such establishments if they are operated in accordance with
the regulations in part 416, Sec. Sec. 416.1 through 416.5 of this
chapter. However, the Administrator may refuse, withdraw, or modify any
exemption under this paragraph when he determines in any specific case
in accordance with the applicable rules of practice that such action is
necessary to effectuate the purposes of this Act.
(d)(1) The requirements of the Act and the regulations in this
subchapter for inspection of the preparation of products do not apply to
operations of types traditionally and usually conducted at retail stores
and restaurants, when conducted at any retail store or restaurant or
similar retail-type establishment for sale in normal retail quantities
or service of such articles to consumers at such establishments.
(2) For purposes of paragraph (d)(1) of this section:
(i) Operations of types traditionally and usually conducted at
retail stores and restaurants are the following:
(a) Cutting up, slicing, and trimming carcasses, halves, quarters,
or wholesale cuts into retail cuts such as steaks, chops, and roasts,
and freezing such cuts;
(b) Grinding and freezing products made from meat;
(c) Curing, cooking, smoking, rendering or refining of livestock
fat, or other preparation of products, except slaughtering or the retort
processing of canned products;
(d) Breaking bulk shipments of products;
(e) Wrapping or rewrapping products.
(ii) Any quantity or product purchased by a consumer from a
particular retail supplier shall be deemed to be a normal retail
quantity if the quantity so purchased does not in the aggregate exceed
one-half carcass. The following amounts of product will be accepted as
representing one-half carcass of the species identified:
------------------------------------------------------------------------
One-half
carcass
pounds
------------------------------------------------------------------------
Cattle...................................................... 300
Calves...................................................... 37.5
Sheep....................................................... 27.5
Swine....................................................... 100
Goats....................................................... 25
------------------------------------------------------------------------
(iii) A retail store is any place of business where:
(a) The sales of product are made to consumers only;
(b) At least 75 percent, in terms of dollar value, of total sales of
product represents sales to household consumers and the total dollar
value of sales of product to consumers other than household consumers
does not exceed the dollar limitation per calendar year set by the
Administrator. This dollar limitation is a figure which will
automatically be adjusted during the first quarter of each calendar
year, upward or downward, whenever the Consumer Price Index, published
by the Bureau of Labor Statistics, Department of Labor, indicates a
change in the price of this same volume of product which exceeds $500.
Notice of the adjusted dollar limitation will be published in the
Federal Register. \1\
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\1\ The dollar limitation currently in effect may be obtained by
contacting Director, Slaughter Inspection Standards and Procedures
Division, Technical Services, Food and Safety Inspection Service, U.S.
Department of Agriculture, Washington, DC 20250 (202) 447-3219.
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[[Page 92]]
(c) Only federally or State inspected and passed product is handled
or used in the preparation of any product, except that product resulting
from the custom slaughter or custom preparation of product may be
handled or used in accordance with paragraph (a)(2) and (b) of this
section but not for sale;
(d) No sale of product is made in excess of a normal retail quantity
as defined in paragraph (d)(2)(ii) of this section;
(e) The preparation of products for sale to household consumers is
limited to traditional and usual operations as defined in paragraph
(d)(2)(i) of this section; and
(f) The preparation of products for sale to other than household
consumers is limited to traditional and usual operations as defined in
paragraph (d)(2)(i) (a), (b), (d), and (e) of this section. (A retail
store at which custom slaughtering or preparation of products is
conducted is not thereby disqualified from exemption as a retail store
under this paragraph (d).)
(iv) Restaurants. (a) A restaurant is any establishment where:
(1) Product is prepared only for sale or service in meals or as
entrees directly to individual consumers at such establishments;
(2) Only federally or State inspected and passed product or such
product prepared at a retail store exempted under paragraph (d)(2)(iii)
of this section is handled or used in the preparation of any product;
(3) No sale of product is made in excess of a normal retail quantity
as defined in paragraph (d)(2)(ii) of this section; and
(4) The preparation of product is limited to traditional and usual
operations as defined in paragraph (d)(2)(i) of this section.
(b) The definition of a restaurant includes a caterer which delivers
or serves product in meals, or as entrees, only to individual consumers
and otherwise meets the requirements of this paragraph.
(c) For purposes of this paragraph, operations conducted at a
restaurant central kitchen facility shall be considered as being
conducted at a restaurant if the restaurant central kitchen prepares
meat or meat food products that are ready to eat when they leave such
facility (i.e., no further cooking or other preparation is needed,
except that they may be reheated prior to serving if chilled during
transportation), transported directly to a receiving restaurant by its
own employees, without intervening transfer or storage, maintained in a
safe, unadulterated condition during transportation, and served in meals
or as entrees only to customers at restaurants, or through vending
machines, owned or operated by the same person that owns or operates
such facility, and which otherwise meets the requirements of this
paragraph: Provided, That the requirements of Sec. Sec. 320.1 through
320.4 of this subchapter apply to such facility. Provided further, That
the exempted facility may be subject to inspection requirements under
the Act for as long as the Administrator deems necessary, if the
Administrator determines that the sanitary conditions or practices of
the facility or the processing procedures or methods at the facility are
such that any of its meat or meat food products are rendered
adulterated. When the Administrator has made such determination and
subjected a restaurant central kitchen facility to such inspection
requirements, the operator of such facility shall be afforded an
opportunity to dispute the Administrator's determination in a hearing
pursuant to rules of practice which will be adopted for this proceeding.
(v) Similar retail-type establishment: Any establishment which is a
combination retail store and restaurant; any delicatessen which meets
the requirements for a retail store or restaurant as prescribed in
paragraphs (d)(2) (iii) or (iv) of this section; or other establishment
as determined by the Administrator in specific cases.
(vi) Consumer: Any household consumer, hotel, restaurant, or similar
institution as determined by the Administrator in specific cases.
(3) Whenever any complaint is received by the Administrator from any
person alleging that any retail store claiming exemption under this
paragraph (d), in any designated State or organized Territory that is
identified under section 205 of the Act (as one
[[Page 93]]
that does not have or is not exercising adequate authority with respect
to recordkeeping requirements) has been operated in violation of the
conditions prescribed in this section for exemption, and the
Administrator, upon investigation of the complaint, has reason to
believe that any such violation has occurred, he shall so notify the
operator of the retail store and afford him reasonable opportunity to
present his views informally with respect to the matter. Thereafter, if
the Administrator still has reason to believe that such a violation has
occurred, and that a requirement that the operator keep records
concerning the operations of the retail store would effectuate the
purposes of the Act, the Administrator shall order the operator to
maintain complete, accurate, and legible records of total monthly
purchases and of total monthly sales of meat, meat byproducts, and meat
food products, in terms of dollar values of the products involved. Such
records shall separately show total sales to household consumers and
total sales to other consumers and shall be maintained for the period
prescribed in Sec. 320.3 of this subchapter. If the operator maintains
copies of bills of lading, receiving and shipping invoices, warehouse
receipts, or similar documents which give the information required
herein, additional records are not required by this subparagraph.
(e)(1) The requirements of the Act and the regulations in this
subchapter for inspection of the preparation of products do not apply to
meat pizzas containing meat food product ingredients which were
prepared, inspected, and passed in a cured or cooked form as ready-to-
eat (i.e., no further cooking or other preparation is needed) in
compliance with the requirements of the Act and these regulations; and
the meat pizzas are to be served in public or private nonprofit
institutions, provided that the meat pizzas are ready-to-eat (i.e., no
further cooking or other preparation is needed, except that they may be
reheated prior to serving if chilled during transportation), transported
directly to the receiving institution by employees of the preparing
firm, receiving institution, or a food service management company
contracted to conduct food service at the public or private nonprofit
institution, without intervening transfer or storage.
(2) The definitions at Chapter 1, 1-102, except 1-102(z) and the
provisions of Chapters 2 through 8, except sections 2-102(a) and (b), 2-
302(d), 2-403(a), 2-403(c), 2-404, 2-405, 2-407, 2-502 through 2-506, 2-
508, 2-509, 4-105, 4-201(c), 4-208, 5-101(a), 5-103, 5-104, 5-202(c), 5-
203, and 6-105, part IV, of the Food and Drug Administration's Food
Service Sanitation Manual (1976 Recommendations), DHEW Publication No.
(FDA) 78-2081, which is incorporated by reference, shall apply to the
facilities and operations of businesses claiming this exemption. (These
materials are incorporated as they exist on the date of approval. This
incorporation by reference was approved by the Director of the Federal
Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies
may be purchased from the Superintendent of Documents, U.S. Government
Printing Office, Washington, DC 20402. It is also available for
inspection at the FSIS Hearing Clerk, room 3171, South Building, Food
Safety and Inspection Service, U.S. Department of Agriculture,
Washington, DC 20250, or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html.
(3) Facilities and operations of businesses claiming this exemption
shall also conform to the following requirements:
(i) Manual cleaning and sanitizing. (A) For manual washing, rinsing
and sanitizing of utensils and equipment, a sink with not fewer than
three compartments shall be provided and used. 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. Fixed equipment and utensils and
equipment too large to be cleaned in sink compartments shall be washed
manually or cleaned through pressure spray methods.
[[Page 94]]
(B) Drain boards or easily movable dish tables of adequate size
shall be provided for proper handling of soiled utensils prior to
washing and for cleaned utensils following sanitizing and shall be
located so as not to interfere with the proper use of the dishwashing
facilities.
(C) Equipment and utensils shall be preflushed or prescraped and,
when necessary, presoaked to remove gross food particles and soil.
(D) Except for fixed equipment and utensils too large to be cleaned
in sink compartments, manual washing, rinsing and sanitizing shall be
conducted in the following sequence:
(1) Sinks shall be cleaned prior to use.
(2) Equipment and utensils shall be thoroughly washed in the first
compartment with a hot detergent solution that is kept clean.
(3) Equipment and utensils shall be rinsed free of detergent and
abrasives with clean water in the second compartment.
(4) Equipment and utensils shall be sanitized in the third
compartment according to one of the methods prescribed in paragraph
(e)(3)(i)(E) (1) through (4) of this section.
(E) The food-contact surfaces of all equipment and utensils shall be
sanitized by:
(1) Immersion for at least \1/2\ minute in clean, hot water at a
temperature of at least 170 [deg]F; or
(2) Immersion for at least 1 minute in a clean solution containing
at least 50 parts per million of available chlorine as a hypochlorite
and at a temperature of at least 75 [deg]F; or
(3) Immersion for at least 1 minute in a clean solution containing
at least 12.5 parts per million of available iodine and having a pH not
higher than 5.0 and at a temperature of at least 75 [deg]F; or
(4) Immersion in a clean solution containing any other chemical
sanitizing agent allowed under 21 CFR 178.1010 that will provide the
equivalent bactericidal effect of a solution containing at least 50
parts per million of available chlorine as a hypochlorite at a
temperature of at least 75 [deg]F for 1 minute; or
(5) Treatment with steam free from materials or additives other than
those specified in 21 CFR 173.310 in the case of equipment too large to
sanitize by immersion, but in which steam can be confined; or
(6) Rinsing, spraying, or swabbing with a chemical sanitizing
solution of at least twice the strength required for that particular
sanitizing solution under paragraph (e)(3)(i)(E)(4) of this section in
the case of equipment too large to sanitize by immersion.
(F) When hot water is used for sanitizing, the following facilities
shall be provided and used:
(1) An integral heating device or fixture installed in, on, or under
the sanitizing compartment of the sink capable of maintaining the water
at a temperature of at least 170 [deg]F; and
(2) A numerically scaled indicating thermometer, accurate to 3 [deg]F, convenient to the sink for frequent checks of
water temperature; and
(3) Dish baskets of such size and design to permit complete
immersion of the tableware, kitchenware, and equipment in the hot water.
(G) When chemicals are used for sanitization, they shall not have
concentrations higher than the maximum permitted under 21 CFR 178.1010
and a test kit or other device that accurately measures the parts per
million concentration of the solution shall be provided and used.
(ii) Mechanical cleaning and sanitizing. (A) Cleaning and sanitizing
may be done by spray-type or immersion dishwashing machines or by any
other type of machine or device if it is demonstrated that it thoroughly
cleans and sanitizes equipment and utensils. These machines and devices
shall be properly installed and maintained in good repair.
Machines and devices shall be operated in accordance with
manufacturers' instructions, and utensils and equipment placed in the
machine shall be exposed to all dishwashing cycles. Automatic detergent
dispensers, wetting agent dispensers, and liquid sanitizer injectors, if
any, shall be properly installed and maintained.
(B) The pressure of final rinse water supplied to spray-type
dishwashing machines shall not be less than 15 nor
[[Page 95]]
more than 25 pounds per square inch measured in the water line
immediately adjacent to the final rinse control valve. A \1/4\-inch IPS
valve shall be provided immediately up stream from the final rinse
control valve to permit checking the flow pressure of the final rinse
water.
(C) Machine or water line mounted numerically scaled indicating
thermometers, accurate to 3 [deg]F, shall be
provided to indicate the temperature of the water in each tank of the
machine and the temperature of the final rinse water as it enters the
manifold.
(D) Rinse water tanks shall be protected by baffles, curtains, or
other effective means to minimize the entry of wash water into the rinse
water. Conveyors in dishwashing machines shall be accurately timed to
assure proper exposure times in wash and rinse cycles in accordance with
manufacturers' specifications attached to the machines.
(E) Drain boards shall be provided and be of adequate size for the
proper handling of soiled utensils prior to washing and of cleaned
utensils following sanitization and shall be so located and constructed
as not to interfere with the proper use of the dishwashing facilities.
This does not preclude the use of easily movable dish tables for the
storage of soiled utensils or the use of easily movable dishtables for
the storage of clean utensils following sanitization.
(F) Equipment and utensils shall be flushed or scraped and, when
necessary, soaked to remove gross food particles and soil prior to being
washed in a dishwashing machine unless a prewashcycle is a part of the
dishwashing machine operation. Equipment and utensils shall be placed in
racks, trays, or baskets, or on conveyors, in a way that food-contact
surfaces are exposed to the unobstructed application of detergent wash
and clean rinse waters and that permits free draining.
(G) Machines (single-tank, stationary-rack, door-type machines and
spray-type glass washers) using chemicals for sanitization may be used:
Provided, That,
(1) The temperature of the wash water shall not be less than 120
[deg]F.
(2) The wash water shall be kept clean.
(3) Chemicals added for sanitization purposes shall be automatically
dispensed.
(4) Utensils and equipment shall be exposed to the final chemical
sanitizing rinse in accordance with manufacturers' specifications for
time and concentration.
(5) The chemical sanitizing rinse water temperature shall be not
less than 75 [deg]F nor less than the temperature specified by the
machine's manufacturer.
(6) Chemical sanitizers used shall meet the requirements of 21 CFR
178.1010.
(7) A test kit or other device that accurately measures the parts
per million concentration of the solution shall be available and used.
(H) Machines using hot water for sanitizing may be used provided
that wash water and pumped rinse water shall be kept clean and water
shall be maintained at not less than the following temperatures:
(1) Single-tank, stationary-rack, dual-temperature machine:
Wash temperature..............................................150 [deg]F
Final rinse temperature.......................................180 [deg]F
(2) Single-tank, stationary-rack, single-temperature machine:
Wash temperature..............................................165 [deg]F
Final rinse temperature.......................................165 [deg]F
(3) Single-tank, conveyor machine:
Wash temperature..............................................160 [deg]F
Final rinse temperature.......................................180 [deg]F
(4) Multitank, conveyor machine:
Wash temperature..............................................150 [deg]F
Pumped rinse temperature......................................160 [deg]F
Final rinse temperature.......................................180 [deg]F
(5) Single-tank, pot, pan, and utensil washer (either stationary or
moving-rack):
Wash temperature..............................................140 [deg]F
Final rinse temperature.......................................180 [deg]F
(I) All dishwashing machines shall be thoroughly cleaned at least
once a day or more often when necessary to maintain them in a
satisfactory operating condition.
(iii) Steam. Steam used in contact with food or food-contact
surfaces shall be free from any materials or additives
[[Page 96]]
other than those specified in 21 CFR 173.310.
(4) For purposes of this paragraph, the term ``private nonprofit
institution'' means ``a corporation, and any community chest, fund, or
foundation, organized and operated exclusively for religious,
charitable, scientific, testing for public safety, literary, or
educational purposes, or to foster national or international amateur
sports competition (but only if no part of its activities involve the
provision of athletic facilities or equipment), or for the prevention of
cruelty to children or animals, no part of the net earnings of which
inures to the benefit of any private shareholder or individual, no
substantial part of the activities of which is carrying on propaganda,
or otherwise attempting, to influence legislation, and which does not
participate in, or intervene in (including the publishing or
distribution of statements), any political campaign on behalf of (or in
opposition to) any candidate for public office.''
(5) The Administrator may withdraw or modify the exemption set forth
in Sec. 303.1(e)(1) for a particular establishment when he or she
determines that such action is necessary to ensure food safety and
public health. Before such action is taken, the owner or operator of the
particular establishment shall be notified, in writing, of the reasons
for the proposed action and shall be given an opportunity to respond, in
writing, to the Administrator within 20 days after notification of the
proposed action. The written notification shall be served on the owner
or operator of the establishment in the manner prescribed in section
1.147(b) of the Department's Uniform Rules of Practice (7 CFR 1.147(b)).
In those instances where there is conflict of any material fact, the
owner or operator of the establishment, upon request, shall be afforded
an opportunity for a hearing with respect to the disputed fact, in
accordance with rules of practice which shall be adopted for the
proceeding. However, such withdrawal or modification shall become
effective pending final determination in the proceeding when the
Administrator determines that an imminent threat to food safety or
public health exists, and that such action is, therefore, necessary to
protect the public health, interest or safety. Such withdrawal or
modification shall be effective upon oral or written notification,
whichever is earlier, to the owner or operator of the particular
establishment as promptly as circumstances permit. In the event of oral
notification, written confirmation shall be given to the owner or
operator of the establishment as promptly as circumstances permit. This
withdrawal or modification shall continue in effect ending the
completion of the proceeding and any judicial review thereof, unless
otherwise ordered by the Administrator.
(f) The adulteration and misbranding provisions of the Act and the
regulations in this subchapter, other than the requirement of the
official inspection legend, apply to articles which are exempted from
inspection or not required to be inspected under this section. This
includes the requirement that any pork and any product containing pork
be prepared only in compliance with any applicable requirement for the
destruction of trichina as provided in Sec. 318.10 of this subchapter.
(g) The Administrator may extend the requirements of titles I and IV
of the Act to any establishment in any State or organized Territory at
which products are prepared for distribution solely within such
jurisdiction, if he determines in accordance with the provisions of
paragraph 301(c)(1) of the Act that it is producing adulterated products
which would clearly endanger the public health.
(h) The Administrator may in specific classes of cases waive for
limited periods any provisions of the regulations in this subchapter in
order to permit appropriate and necessary action in the event of a
public health emergency or to permit experimentation so that new
procedures, equipment, and/or processing techniques may be tested to
facilitate definite improvements: Provided, That such waivers of the
provisions of such regulations are not in
[[Page 97]]
conflict with the purposes or provisions of the Act.
(Approved by the Office of Management and Budget under control number
0583-0015)
[35 FR 15558, Oct. 3, 1970, as amended at 36 FR 12002, 12004, June 24,
1971; 45 FR 27922, Apr. 25, 1980; 46 FR 46288, Sept. 18, 1981; 47 FR
746, Jan. 7, 1982; 51 FR 29909, Aug. 21, 1986; 52 FR 10032, Mar. 30,
1987; 52 FR 48091, Dec. 18, 1987; 53 FR 24679, June 30, 1988; 57 FR
34182, Aug. 3, 1992; 64 FR 56415, Oct. 20, 1999]