[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: 9CFR381.10]
[Page 434-441]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 381_POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
Subpart C_Exemptions
Sec. 381.10 Exemptions for specified operations.
(a) The requirements of the Act and the regulations for inspection
of the processing of poultry and poultry products shall not apply to:
(1) Any retail dealer with respect to poultry products sold in
commerce directly to consumers in an individual retail store, if the
only processing operation performed by such retail dealer is the cutting
up of poultry products on the premises where such sales to consumers are
made: Provided, That such operation is conducted under such sanitary
standards, practices, and procedures as result in the preparation of
poultry products that are not adulterated: And provided further, That
the poultry products sold in commerce are derived from poultry inspected
and passed under the Act and such poultry products are not adulterated
or misbranded at the time of sale (except that the official inspection
legend shall not be used). (For the purposes of this subparagraph, a
retail dealer is any person who sells poultry products directly to
consumers as defined in paragraph (d)(2)(vi) of this section and whose
sales of poultry products to household consumers constitute, in terms of
dollar value, at least 75 percent of his total sales of poultry
products.)
(2) The slaughter of poultry, and the processing of poultry
products, by any person in any territory not organized with a
legislative body, solely for distribution within such territory:
Provided, That such poultry is sound and healthy and is slaughtered
under such sanitary standards, practices, and procedures as result in
the preparation of poultry products that are not adulterated: And
provided further, That the poultry products are not adulterated or
misbranded when so distributed (except that the official inspection
legend shall not be used).
(3) The slaughtering by any person of poultry of his own raising,
and the processing by him and transportation in commerce of the poultry
products exclusively for use by him and members of his household and his
nonpaying guests and employees: Provided, That in lieu of complying with
all the adulteration and misbranding provisions of the Act, such poultry
is healthy and is slaughtered and processed under such sanitary
standards, practices, and procedures as result in the preparation of
poultry products that are sound, clean, and fit for human food, and the
shipping containers of such poultry products bear the producer's name
and address and the statement ``Exempted--P.L. 90-492.''
(4) The custom slaughter by any person of poultry delivered by the
owner thereof for such slaughter, and the processing by such slaughterer
and transportation in commerce of the poultry products exclusively for
use, in the household of such owner, by him and members of his household
and his nonpaying guests and the employees: Provided, That such custom
slaughterer does not engage in the business of buying or selling any
poultry products capable of use as human food: And provided further,
That in lieu of complying with all the adulteration and misbranding
provisions of the Act, such poultry is healthy and is slaughtered and
processed under such sanitary standards, practices, and procedures as
result in the preparation of poultry products that are sound, clean and
fit for human food, and the shipping containers of such poultry products
bear the owner's name and address and the statement ``Exempted--P.L. 90-
492.''
(5) The slaughtering of sound and healthy poultry and processing of
poultry products therefrom in any State or territory or the District of
Columbia by any poultry producer on his own premises with respect to
poultry raised on his premises, and the distribution by any person
solely within such jurisdiction of the poultry products derived from
such operations: Provided, That (i) in lieu of complying with all the
adulteration provisions of the Act, such poultry is slaughtered and
otherwise processed and handled under such sanitary standards,
practices, and procedures as result in the preparation of poultry
products that are sound, clean, and fit for human food when so
distributed; (ii) such poultry products when
[[Page 435]]
so distributed, bear (in lieu of labeling that would otherwise be
required) the producer's name and address and the statement ``Exempted--
P.L. 90-492'' and such poultry products are not otherwise misbranded;
(iii) such producer and distributor do not engage in the current
calendar year in the business of buying or selling any poultry or
poultry products other than as specified in this paragraph (a) (5) or
(6) of this section; and (iv) neither such producer or distributor
slaughters or processes the products of more poultry than allowed by
paragraph (b) of this section.
(6) The slaughtering of sound and healthy poultry or the processing
of poultry products of such poultry in any State or territory or the
District of Columbia by any poultry producer or other person for
distribution by him solely within such jurisdiction directly to
household consumers, restaurants, hotels, and boardinghouses, for use in
their own dining rooms, or in the preparation of meals for sales direct
to consumers: Provided, That (i) in lieu of complying with all the
adulteration provisions of the Act, such poultry is slaughtered and
otherwise processed and handled under such sanitary standards,
practices, and procedures as result in the preparation of poultry
products that are sound, clean, and fit for human food when distributed
by such processor; (ii) such poultry products when so distributed bear
(in lieu of labeling that would otherwise be required) the processor's
name and address and the statement ``Exempted--P.L. 90-492'' and such
poultry products are not otherwise misbranded; (iii) such processor does
not engage in the current calendar year in the business of buying or
selling any poultry or poultry products other than as specified in this
paragraph (a) (6) or (5) of this section; and (iv) such processor does
not exceed the volume limitation prescribed in paragraph (b) of this
section.
(7) The operations and products of small enterprises (including
poultry producers) not exempted under paragraphs (a) (1) through (6) of
this section that are engaged in any State or territory or the District
of Columbia in slaughtering and/or cutting up poultry for distribution
as carcasses or parts thereof solely for distribution within such
jurisdiction; Provided, That (i) such poultry is sound and healthy when
slaughtered and is slaughtered and/or cut up and handled under such
sanitary standards, practices and procedures as result in the
preparation of poultry products that are not adulterated when so
distributed; and (ii) when so distributed, such poultry products are not
misbranded (except that the official inspection legend shall not be
used).
(b) No person qualifies for any exemption specified in paragraph
(a)(5), (6), or (7) of this section if, in the current calendar year,
such person:
(1) Slaughters or processes the products of more than 20,000
poultry, or
(2) Slaughters or processes poultry products at a facility used for
slaughtering or processing poultry products by any other person, except
when the Administrator grants such exemption after determining, upon
review of a person's application, that such an exemption will not impair
effectuating the purposes of the Act.
(c) The provisions of the Act and the regulations do not apply to
any poultry producer with respect to poultry, of his own raising on his
own farm, which he slaughters if:
(1) Such producer slaughters not more than 1,000 poultry during the
calendar year for which this exemption is being determined;
(2) Such poultry producer does not engage in buying or selling
poultry products other than those produced from poultry raised on his
own farm; and
(3) None of such poultry moves in ``commerce'' (as defined in Sec.
381.1).
(d)(1) The requirements of the Act and the regulations for
inspection of the processing of poultry and poultry 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 the purposes of paragraph (d)(1) of this section:
(i) Operations of types traditionally and usually conducted at
retail stores
[[Page 436]]
and restaurants include any processing of poultry products except
canning of poultry products and except slaughtering of poultry unless
such slaughtering is conducted at a retail store with respect to live
poultry purchased by the consumer at the retail store and processed by
the retail store operator in accordance with the consumer's
instructions.
(ii) A normal retail quantity is any quantity of a poultry product
purchased by a household consumer from a retail supplier that in the
aggregate does not exceed 75 pounds. A normal retail quantity sold by a
retail supplier to other than a household consumer is any quantity that
in the aggregate does not exceed 150 pounds.
(iii) A retail store is any place of business where:
(a) The sales of poultry products 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 Safety and Inspection Service, U.S.
Department of Agriculture, Washington, DC 20250 (202) 447-3219.
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(c) Only federally or State inspected and passed, or exempted (or,
as provided in Sec. 381.223, State or local agency inspected and passed
or exempted) poultry products are handled or used in the preparation of
any poultry products;
(d) No sale of poultry products is made in excess of a normal retail
quantity as defined in paragraph (d)(2)(ii) of this section; and
(e) The processing of poultry products for sale is limited to
traditional and usual operations as defined in paragraph (d)(2)(i) of
this section.
(iv) Restaurants. (a) A restaurant is any establishment where:
(1) Poultry products are processed only for sale or service in meals
or as entrees directly to individual consumers at such establishments;
(2) Only federally inspected and passed, or exempted (or, as
provided in Sec. 381.223, State or local agency inspected and passed or
exempted) poultry products are handled or used in the preparation of any
poultry products;
(3) No sale of poultry products is made in excess of a normal retail
quantity as defined in paragraph (d)(2)(ii) of this section; and
(4) The processing of poultry products 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 as a
restaurant central kitchen facility shall be considered as being
conducted at a restaurant if the restaurant central kitchen prepares
poultry 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 requirement of this paragraph:
Provided, That the requirements of Sec. Sec. 381.175 through 381.178 of
this subchapter apply to such facility. Provided further, That the
exempted facility
[[Page 437]]
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 poultry
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) A similar retail-type establishment is 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
paragraph (d)(2) (iii) or (iv) of this section; or other establishment
as determined by the Administrator in specific cases.
(vi) A consumer is any household consumer, hotel, or 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 establishment or restaurant claiming
exemption under this paragraph (d) in any designated State or organized
territory listed in Sec. 381.221 that is also identified in Sec.
381.224 as a jurisdiction 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 paragraph (d)
for such 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 establishment or
restaurant and afford him reasonable opportunity to present his views
informally with respect to the matter. Thereafter, if the Administrator
determines that such a violation has occurred, and that a requirement
that the operator keep records concerning the operations of the retail
establishment or restaurant would effectuate the purposes of the Act,
the Administrator shall order the operator to maintain complete,
accurate, and legible records of his total monthly purchases and of his
total monthly sales of poultry and poultry products. 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. 381.177. 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.
(4) The adulteration and misbranding provisions of the Act and the
regulations other than the requirement of the official inspection
legend, apply to articles which are exempted from inspection under this
paragraph (d).
(e)(1) The requirements of the Act and the regulations in this
subchapter for inspection of the preparation of products do not apply to
poultry pizzas containing poultry 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 poultry pizzas are to be served in public or private nonprofit
institutions, provided that the poultry 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,
[[Page 438]]
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.
(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:
[[Page 439]]
(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 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 upstream 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.
[[Page 440]]
(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 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. 381.10(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 pending the
completion of the proceeding and any judicial review thereof, unless
otherwise ordered by the Administrator.
[[Page 441]]
(6) The adulteration and misbranding provisions of the Act and the
regulations apply to articles which are exempted from inspection under
Sec. 381.10(e).
[37 FR 9706, May 16, 1972, as amended at 38 FR 16991, June 28, 1973; 45
FR 27922, Apr. 25, 1980; 46 FR 46288, Sept. 16, 1981; 48 FR 2959, Jan.
24, 1983; 51 FR 29909, Aug. 21, 1986; 53 FR 24679, June 30, 1988; 57 FR
34184, Aug. 3, 1992]