[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.10]

[Page 431-438]
 
                  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 so distributed, bear (in 
lieu of labeling that would otherwise be required) the producer's name 
and address and the

[[Page 432]]

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 proc[chyph]essor 
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 and restaurants include any processing of poultry products 
except canning of

[[Page 433]]

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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    (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 may be subject to inspection requirements under the 
Act for as long as the Administrator deems necessary if the

[[Page 434]]

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 435]]

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 Office of the Federal Register 
Information Center, Suite 700, 800 North Capitol Street, NW., 
Washington, DC, or the FSIS Hearing Clerk, room 3171, South Building, 
Food Safety and Inspection Service, U.S. Department of Agriculture, 
Washington, DC 20250.)
    (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:
    (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

[[Page 436]]

    (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.
    (7) A test kit or other device that accurately measures the parts 
per million concentration of the solution shall be available and used.

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    (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 438]]

    (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]