This electronic document was downloaded from the GPO web site, November 2003,
and is provided for information purposes only. The Code of Federal Regulations,
Title 9, is updated January 1 of each year.
The most current version of the regulations may be found at the
GPO web site.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR318]
[Page 229-230]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec.
318.1 Products and other articles entering official establishments.
318.2 Reinspection, retention, and disposal of meat and poultry
products at official establishments.
318.3 Designation of places of receipt of products and other articles
for reinspection.
318.4 Preparation of products to be officially supervised;
responsibilities of official establishments; plant operated
quality control.
318.5 Requirements concerning procedures.
318.6 Requirements concerning ingredients and other articles used in
preparation of products.
318.8 Preservatives and other substances permitted in product for
export only; handling; such product not to be used for
domestic food purposes.
318.9 Samples of products, water, dyes, chemicals, etc., to be taken
for examination.
318.10 Prescribed treatment of pork and products containing pork to
destroy trichinae.
318.11 [Reserved]
[[Page 230]]
318.12 Manufacture of dog food or similar uninspected article at
official establishments.
318.13 Mixtures containing product but not amendable to the Act.
318.14 Adulteration of product by polluted water; procedure for
handling.
318.15 Tagging chemicals, preservatives, cereals, spices, etc., "U.S.
retained."
318.16 Pesticide chemicals and other residues in products.
318.17 Requirements for the production of cooked beef, roast beef, and
cooked corned beef products.
318.18 Handling of certain material for mechanical processing.
318.19 Compliance procedure for cured pork products.
318.20 Use of animal drugs.
318.21 Accreditation of chemistry laboratories.
318.22 Determination of added water in cooked sausages.
318.23 Heat-processing and stabilization requirements for uncured meat
patties.
318.24 Compliance procedures for meat derived from advanced meat/bone
separation machinery and recovery systems.
Subparts B-F [Reserved]
Subpart G--Canning and Canned Products
318.300 Definitions.
318.301 Containers and closures.
318.302 Thermal processing.
318.303 Critical factors and the application of the process schedule.
318.304 Operations in the thermal processing area.
318.305 Equipment and procedures for heat processing systems.
318.306 Processing and production records.
318.307 Record review and maintenance.
318.308 Deviations in processing.
318.309 Finished product inspection.
318.310 Personnel and training.
318.311 Recall procedure.
Authority: 7 U.S.C. 38f, 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR
2.18, 2.53.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR318.1]
[Page 230-231]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.1 Products and other articles entering official establishments.
Source: 35 FR 15586, Oct. 3, 1970, unless otherwise noted.
(a) Except as otherwise provided in paragraphs (g) and (h) of this
section or Sec. 318.12, no product shall be brought into an official
establishment unless it has been prepared only in an official
establishment and previously inspected and passed by a Program employee,
and is identified by an official inspection legend as so inspected and
passed. Notwithstanding the foregoing provisions of this subparagraph,
product imported in accordance with part 327 of this subchapter and not
prepared in the United States outside an official establishment, may
enter any official establishment subject in other respects to the same
restrictions as apply to domestic product. Products received in an
official establishment during the Program employees absence shall be
identified and maintained in a manner acceptable to such employee.
Product entering any official establishment shall not be used or
prepared thereat until it has been reinspected in accordance with
Sec. 318.2. Any product originally prepared at any official
establishment may not be returned into any part of such establishment,
except the receiving area approved under Sec. 318.3, until it has been
reinspected by the inspector.
(b) No slaughtered poultry or poultry product shall be brought into
an official establishment unless it has been (1) previously inspected
and passed and is identified as such in accordance with the requirements
of the Poultry Products Inspection Act (21 U.S.C. 451 et seq.) and the
regulations thereunder, and has not been prepared other than in an
establishment inspected under said Act, or (2) has been inspected and
passed and is identified as such in accordance with the requirements of
a State law.
(c) Every article for use as an ingredient in the preparation of
meat food products, when entering any official establishment and at all
times while it is in such establishment, shall bear a label showing the
name of the article, the amount or percentage therein of any substances
restricted by this part or part 317 of this subchapter, and a list of
ingredients in the article if composed of two or more ingredients:
Provided, That in the case of articles received in tank car lots, only
one such label shall be used to identify each lot. In addition, the
label must show the name and address of the shipper.
(d) To ensure the safe use of preparations used in hog scalding
water or in
[[Page 231]]
the denuding of tripe, the label or labeling on containers of such
preparations shall bear adequate directions to ensure use in compliance
with any limitations prescribed in 21 CFR Chapter I, Subchapter A or
Subchapter B, or 9 CFR Chapter III, Subchapter A or Subchapter E.
(e) Dyes, chemicals, or other substances the use of which is
restricted to certain products may be brought into or kept in an
official establishment only if such products are prepared thereat. No
prohibited dye, chemical, preservative, or other substance shall be
brought into or kept in an official establishment.
(f) [Reserved]
(g) Glands and organs, such as cotyledons, ovaries, prostate glands,
tonsils, spinal cords, and detached lymphatic, pineal, pituitary,
parathyroid, suprarenal, pancreatic and thyroid glands, used in
preparing pharmaceutical, organotherapeutic, or technical products and
which are not used as human food (whether or not prepared at official
establishments) may be brought into and stored in edible product
departments of inspected establishments if packaged in suitable
containers so that the presence of such glands and organ will in no way
interfere with the maintenance of sanitary conditions or constitute an
interference with inspection. Glands or organs which are regarded as
human food products, such as livers, testicles, and thymus glands, may
be brought into official establishments for pharmaceutical,
organotherapeutic or technical purposes, only if U.S. inspected and
passed and so identified. Lungs and lung lobes derived from livestock
slaughtered in any establishment may not be brought into any official
establishment except as provided in Sec. 318.12(a).
(h)(1) Carcasses of game animals, and carcasses derived from the
slaughter by any person of livestock of his own raising in accordance
with the exemption provisions of paragraph 23(a) of the Act, and parts
of such carcasses, may be brought into an official establishment for
preparation, packaging, and storing in accordance with the provisions of
Sec. 303.1(a)(2) of this subchapter.
(2) Meat, meat byproducts, and meat food products bearing official
marks showing that they were inspected and passed under State inspection
in any State not designated in Sec. 331.2 of this subchapter may be
received by official establishments for storage and distribution solely
in intrastate commerce. The presence of such State inspected products
must not create any unsanitary condition or otherwise result in
adulteration of any products at the official establishment or interfere
with the conduct of inspection under this subchapter. In addition, such
State inspected products must be stored separately and apart from the
federally inspected products in the official establishment.
(i) The operator of the official establishment shall furnish such
information as is necessary to determine the origin of any product or
other article entering the official establishment. Such information
shall include, but is not limited to, the name and address of the seller
or supplier, transportation company, agent, or broker involved in the
sale or delivery of the product or article in question.
(j) Any product or any poultry or poultry product or other article
that is brought into an official establishment contrary to any provision
of this section may be required by the Administrator to be removed
immediately from such establishment by the operator thereof, and failure
to comply with such requirement shall be deemed a violation of this
regulation. If any slaughtered poultry or poultry products or other
articles are received at an official establishment and are suspected of
being adulterated or misbranded under the Poultry Products Inspection
Act or the Federal Food, Drug, and Cosmetic Act, or applicable State
laws, the appropriate governmental authorities will be notified.
[35 FR 15586, Oct. 3, 1970, as amended at 36 FR 11639, June 17, 1971; 38
FR 5152, Feb. 26, 1973; 48 FR 6091, Feb. 10, 1983; 49 FR 32055, Aug. 10,
1984; 64 FR 72174, Dec. 23, 1999]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR318.2]
[Page 231-232]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.2 Reinspection, retention, and disposal of meat and poultry products at official establishments.
(a) All products and all slaughtered poultry and poultry products
brought
[[Page 232]]
into any official establishment shall be identified by the operator of
the official establishment at the time of receipt at the official
establishment and shall be subject to reinspection by a Program employee
at the official establishment in such manner and at such times as may be
deemed necessary to assure compliance with the regulations in this
subchapter.
(b) All products, whether fresh, cured, or otherwise prepared, even
though previously inspected and passed, shall be reinspected by Program
employees as often as they may deem necessary in order to ascertain that
they are not adulterated or misbranded at the time they enter or leave
official establishments and that the requirements of the regulations in
this subchapter are complied with.
(c) Reinspection may be accomplished through use of statistically
sound sampling plans that assure a high level of confidence. The circuit
supervisor shall designate the type of plan and the program employee
shall select the specific plan to be used in accordance with
instructions issued by the Administrator. \1\
---------------------------------------------------------------------------
\1\ Further information concerning sampling plans which have been
adopted for specific products may be obtained from the Circuit
Supervisors of Program circuits. These sampling plans are developed for
individual products by the Washington staff and will be distributed for
field use as they are developed. The type of plan applicable depends on
factors such as whether the product is in containers, stage of
preparation, and procedures followed by the establishment operator. The
specific plan applicable depends on the kind of product involved, such
as liver, oxtails, etc.
---------------------------------------------------------------------------
(d) A U.S. retained tag shall be placed by a Program employee at the
time of reinspection at any official establishment on all products which
are suspected on such reinspection of being adulterated or misbranded,
and such products shall be held for further inspection. Such tags shall
be removed only by authorized Program employees. When further inspection
is made, if the product is found to be adulterated, all official
inspection legends or other official marks for which the product is
found to be ineligible under the regulations in this subchapter, shall
be removed or defaced and the product will be subject to condemnation
and disposal in accordance with part 314 of this subchapter, except that
a determination regarding adulteration may be deferred if a product has
become soiled or unclean by falling on the floor or in any other
accidental way or if the product is affected with any other condition
which the inspector deems capable of correction, in which case the
product shall be cleaned (including trimming if necessary) or otherwise
handled in a manner approved by the inspector to assure that it will not
be adulterated or misbranded and shall then be presented for
reinspection and disposal in accordance with this section. If upon final
inspection, the product is found to be neither adulterated nor
misbranded, the inspector shall remove the U.S. retained tag. If a
product is found upon reinspection to be misbranded, it shall be held
under a U.S. retained tag, or a U.S. detention tag as provided in part
329 of this subchapter, pending correction of the misbranding or
issuance of an order under section 7 of the Act to withhold from use the
labeling or container of the product, or the institution of a judicial
seizure action under section 403 of Act or other appropriate action. The
inspector shall make a complete record of each transaction under this
paragraph and shall report his action to the area supervisor.
[35 FR 15586, Oct. 3, 1970; 36 FR 11903, June 23, 1971]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR318.3]
[Page 232]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.3 Designation of places of receipt of products and other articles for reinspection.
Every official establishment shall designate, with the approval of
the circuit supervisor, a dock or place at which products and other
articles subject to reinspection under Sec. 318.2 shall be received, and
such products and articles shall be received only at such dock or place.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR318.4]
[Page 232-235]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.4 Preparation of products to be officially supervised; responsibilities of official establishments; plant operated quality control.
(a) All processes used in curing, pickling, rendering, canning, or
otherwise
[[Page 233]]
preparing any product in official establishments shall be supervised by
Program employees unless such preparation is conducted as a custom
operation exempted from inspection under Sec. 303.1(a)(2) of this
subchapter in any official establishment or consists of operations that
are exempted from inspection under Sec. 303.1(d) of this subchapter and
are conducted in a retail store in an establishment subject to
inspection only because the State or Territory in which the
establishment is located is designated under paragraph 301(c) of the
Act. No fixtures or appliances, such as tables, trucks, trays, tanks,
vats, machines, implements, cans, or containers of any kind, shall be
used unless they are of such materials and construction as will not
contaminate or otherwise adulterate the product and are clean and
sanitary. All steps in the preparation of edible products shall be
conducted carefully and with strict cleanliness in rooms or compartments
separate from those used for inedible products.
(b) It shall be the responsibility of the operator of every official
establishment to comply with the Act and the regulations in this
subchapter. In order to carry out this responsibility effectively, the
operator of the establishment shall institute appropriate measures to
assure the maintenance of the establishment and the preparation,
marking, labeling, packaging and other handling of its products strictly
in accordance with the sanitary and other requirements of this
subchapter. The effectiveness of such measures will be subject to review
by the Department.
(c) Applying for Total Plant Quality Control. Any owner or operator
of an official establishment preparing meat food product who has a total
plant quality control system or plan for controlling such product, after
ante-mortem and post-mortem inspection, through all stages of
preparation, may request the Administrator to evaluate it to determine
whether or not that system is adequate to result in product being in
compliance with the requirements of the Act and therefore qualify as a
U.S. Department of Agriculture (USDA) Total Plant Quality Control
Establishment. Such a request shall, as a minimum, include:
(1) A letter to the Administrator from the establishment owner of
operator stating the company's basis and purpose for seeking an approved
quality control system and willingness to adhere to the requirements of
the system as approved by the Department; that all the establishment's
data, analyses, and information generated by its quality control system
will be maintained to enable the Department to monitor compliance and
available to Department personnel; that plant quality control personnel
will have authority to halt production or shipping of product in cases
where the submitted quality control system requires it; and that the
owner or operator (or his/her designee) will be available for
consultation at any time Department personnel consider it necessary.
(2) In the case of an establishment having one or more full-time
persons whose primary duties are related to the quality control system,
an organizational chart showing that such people ultimately report to an
establishment official whose quality control responsibilities are
independent of or not predominantly production responsibilities. In the
case of an establishment which does not have full-time quality control
personnel, information indicating the nature of the duties and
responsibilities of the person who will be responsible for the quality
control system.
(3) A list identifying those parts and sections of the Federal meat
inspection regulations which are applicable to the operations of the
establishment applying for approval of a quality control system. This
list shall also identify which part of the quality control system will
serve to maintain compliance with the applicable regulations.
(4) Detailed information concerning the manner in which the system
will function. Such information should include, but not necessarily be
limited to, questions of raw material control, the critical check or
control points, the nature and frequency of tests to be made, the nature
of charts and other records that will be used, the length of time such
charts and records will be maintained in the custody of the official
establishment, the nature of deficiencies the quality control system is
[[Page 234]]
designed to identify and control, the parameters or limits which will be
used, and the points at which corrective action will occur and the
nature of such corrective action--ranging from least to most severe:
Provided, That, subsequent to approval of the total plant quality
control system by the Administrator, the official establishment may
produce a new product for test marketing provided labeling for the
product has been approved by the Administrator, the inspector in charge
has determined that the procedures for preparing the product will assure
that all Federal requirements are met, and the production for test
marketing does not exceed 6 months. Such new product shall not be
produced at that establishment after the 6-month period unless approval
of the quality control system for that product has been received from
the Administrator.
(d) [Reserved]
(e) Evaluation and Approval of Total Plant Quality Control. (1) The
Administrator shall evaluate the material presented in accordance with
the provisions of paragraph (c) of this section. If it is determined by
the Administrator, on the basis of the evaluation, that the total
quality control system will result in finished products controlled in
this manner being in full compliance with the requirements of the Act
and regulations thereunder, the total quality control system will be
approved and plans will be made for implementation under departmental
supervision.
(2) In any situation where the system is found by the Administrator
to be unacceptable, formal notification shall be given to the applicant
of the basis for the denial. The applicant will be afforded an
opportunity to modify the system in accordance with the notification.
The applicant shall also be afforded an opportunity to submit a written
statement in response to this notification of denial and a right to
request a hearing with respect to the merits or validity of the denial.
If the applicant requests a hearing and the Administrator, after review
of the answer, determines the initial determination to be correct, he
shall file with the Hearing Clerk of the Department the notification,
answer and the request for hearing, which shall constitute the complaint
and answer in the proceeding, which shall thereafter be conducted in
accordance with Rules of Practice which shall be adopted for this
proceeding.
(3) The establishment owner or operator shall be responsible for the
effective operation of the approved total plant quality control system
to assure compliance with the requirements of the Act and regulations
thereunder. The Secretary shall continue to provide the Federal
inspection necessary to carry out his responsibilities under the Act.
(f) Labeling Logo. Owners and operators of official establishments
having a total plant quality control system approved under the
provisions of paragraph (c) of this section, may only use, as a part of
any labeling, the following logo. Any labeling bearing the logo and any
wording of explanation with respect to this logo shall be approved as
required by parts 316 and 317 of this subchapter.
[GRAPHIC] [TIFF OMITTED] TC11SE91.015
(g) Termination of Total Plant Quality Control. (1) The approval of
a total plant quality control system may be terminated at any time by
the owner or operator of the official establishment upon written notice
to the Administrator.
(2) The approval of a total plant quality control system may be
terminated upon the establishment's receipt of a written notice from the
Administrator under the following conditions:
[[Page 235]]
(i) If adulterated or misbranded meat food product is found by the
Administrator to have been prepared for or distributed in commerce by
the subject establishment. In such case, opportunity will be provided to
the establishment owner or operator to present views to the
Administrator within 30 days of the date of terminating the approval. In
those instances where there is conflict of facts, a hearing, under
applicable Rules of Practice, will be provided to the establishment
owner or operator to resolve the conflict. The Administrator's
termination of approval shall remain in effect pending the final
determination of the proceeding.
(ii) If the establishment fails to comply with the quality control
system or program to which it has agreed after being notified by letter
from the Administrator or his designee. Prior to such termination,
opportunity will be provided to the establishment owner or operator to
present views to the Administrator within 30 days of the date of the
letter. In those instances where there is a conflict of facts, a
hearing, under applicable Rules of Practice, will be provided to the
establishment owner or operator to resolve the conflict. The
Administrator's termination of quality control approval shall remain in
effect pending the final determination of the proceeding.
(3) If approval of the total establishment quality control system
has been terminated in accordance with the provisions of this section,
an application and request for approval of the same or a modified total
establishment quality control system will not be evaluated by the
Administrator for at least 6 months from the termination date.
(h)(1) Operating Schedule Under Total Plant Quality Control. An
official establishment with an approved total plant quality control
system may request approval for an operating schedule of up to 12
consecutive hours per shift. Permission will be granted provided that:
(i) The official establishment has satisfactorily operated under a
total plant quality control system for at least 1 year.
(ii) All products prepared and packaged, or processed after the end
of 8 hours of inspection shall only be a continuation of the processing
monitored by the inspector and being conducted during the last hour of
inspection.
(iii) All immediate containers of products prepared and packaged
shall bear code marks that are unique to any period of production beyond
the 8 hours of inspection. The form of such code marks will remain
constant from day to day, and a facsimile of the code marks and their
meaning shall be provided to the inspector.
(2) Application. Applications shall be submitted to the Regional
Director and shall specify how the conditions in Sec. 318.4(h)(1) have
been or will be met.
(3) Monitoring by Inspectors. In order to verify that an
establishment is preparing and shipping product in accordance with the
approved total plant quality control system and the Act and regulations
after the 8 hours of inspection, the official establishment may be
provided overtime inspection services at the discretion of the circuit
supervisor and charged for such services.
(Reporting requirements were approved by the Office of Management and
Budget under control number 0583-0015)
[35 FR 15586, Oct. 3, 1970, as amended at 36 FR 12003, June 24, 1971; 45
FR 54322, Aug. 15, 1980; 51 FR 32304, Sept. 11, 1986; 62 FR 45024, Aug.
25, 1997; 62 FR 54759, Oct. 22, 1997; 65 FR 34389, May 30, 2000]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR318.5]
[Page 235-236]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.5 Requirements concerning procedures.
(a)(1) Care shall be taken to assure that product is not adulterated
when placed in freezers. If there is doubt as to the soundness of any
frozen product, the inspector will require the defrosting and
reinspection of a sufficient quantity thereof to determine its actual
condition.
(2) Frozen product may be defrosted in water or pickle in a manner
and with the use of facilities which are acceptable to the inspector.
Before such product is defrosted, a careful examination shall be made to
determine its condition. If necessary, this examination shall include
defrosting of representative samples by means other than in water or
pickle.
(b) Product, such as pork tenderloins, brains, sweetbreads, stew, or
chop suey, shall not be packed in hermetically sealed metal or glass
containers,
[[Page 236]]
unless subsequently heat processed or otherwise treated to preserve the
product in a manner approved by the Administrator in specific cases.
(c) Care shall be taken to remove bones and parts of bones from
product which is intended for chopping.
(d) Heads for use in the preparation of meat food products shall be
split and the bodies of the teeth, the turbinated and ethmoid bones, ear
tubes, and horn butts removed, and the heads then thoroughly cleaned.
(e) Kidneys for use in the preparation of meat food products shall
first be freely sectioned and then thoroughly soaked and washed. All
detached kidneys, including beef kidneys with detached kidney fat, shall
be inspected before being used in or shipped from the official
establishment.
(f) Cattle paunches and hog stomachs for use in the preparation of
meat food products shall be thoroughly cleaned on all surfaces and parts
immediately after being emptied of their contents, which shall follow
promptly their removal from the carcasses.
(g) Clotted blood shall be removed from hog hearts before they are
shipped from the official establishment or used in the preparation of
meat food products.
(h) Beef rounds, beef bungs, beef middles, beef bladders, calf
rounds, hog bungs, hog middles, and hog stomachs which are to be used as
containers of any meat food product shall be presented for inspection,
turned with the fat surface exposed.
(i) Portions of casings which show infection with Oesophagostomum or
other nodule-producing parasite, and weasands infected with the larvae
of Hypoderma lineatum, shall be rejected, except that when the
infestation is slight and the nodules and larvae are removed, the casing
or weasand may be passed.
[35 FR 15586, Oct. 3, 1970; 36 FR 11903, June 23, 1971]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR318.6]
[Page 236-237]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.6 Requirements concerning ingredients and other articles used in preparation of products.
(a) All ingredients and other articles used in the preparation of
any product shall be clean, sound, healthful, wholesome, and otherwise
such as will not result in the product being adulterated. Official
establishments shall furnish inspectors accurate information on all
procedures involved in product preparation including product composition
and any changes in such procedures essential for inspectional control of
the product.
(b)(1) The only animal casings that may be used as containers of
product are those from cattle, sheep, swine, or goats.
(2) Casings for products shall be carefully inspected by Program
employees. Only those casings which have been carefully washed and
thoroughly flushed with clean water immediately before stuffing and are
suitable for containers, are clean, and are passed on such inspection
shall be used, except that preflushed animal casings packed in salt or
salt and glycerine solution or other approved medium may be used without
additional flushing provided they are found to be clean and otherwise
acceptable and are thoroughly rinsed before use.
(3) Hog and sheep casings intended for use as containers of product
may be treated by soaking in or applying thereto sound, fresh pineapple
juice or papain or bromelin or pancreatic extract to permit the enzymes
contained in these substances to act on the casings to make them less
resistant. The casings shall be handled in a clean and sanitary manner
throughout and the treatment shall be followed by washing and flushing
the casings with water sufficiently to effectively remove the substance
used and terminate the enzymatic action.
(4) On account of the invariable presence of bone splinters,
detached spinal cords shall not be used in the preparation of edible
product other than for rendering where they constitute a suitable raw
material.
(5) Testicles if handled as an edible product may be shipped from
the official establishment as such, but they shall not be used as an
ingredient of a meat food product.
(6) Tonsils shall be removed and shall not be used as ingredients of
meat food products.
(7) Blood from livestock prepared in accordance with Sec. 310.20 of
this subchapter may be used as an ingredient
[[Page 237]]
of a meat food product for which a standard is prescribed in part 319 of
this subchapter, if permitted by such standard, and may be used in any
meat food product for which no such standard is prescribed in part 319
of this subchapter if it is a common and usual ingredient of such
product.
(8) Intestines shall not be used as ingredients in any meat food
product for which a standard is prescribed in part 319 of this
subchapter and shall not be used in other products unless the products
are labeled in accordance with Sec. 317.8(b)(3) of this subchapter.
(9) Poultry products and egg products (other than shell eggs) which
are intended for use as ingredients of meat food products shall be
considered acceptable for such use only when identified as having been
inspected and passed for wholesomeness by the Department under the
regulations in 7 CFR part 59 or 9 CFR part 362 or 381 and when found to
be sound and otherwise acceptable when presented for use. Poultry
products and egg products (other than shell eggs) which have not been so
inspected and passed for wholesomeness shall not be used in the
preparation of such meat food products.
(10) Dry milk products which are intended for use as ingredients of
meat food products shall be considered acceptable for such use only when
produced in a plant approved by the Department under the regulations in
7 CFR part 58, and when found to be sound and otherwise acceptable when
presented for use. Dry milk products prepared in a plant not so approved
shall not be used in the preparation of such meat food products.
(11) [Reserved]
(12) Ingredients for use in any product may not bear or contain any
pesticide chemical or other residues in excess of level permitted in
Sec. 318.16.
(13) Use of "Mechanically Separated (Kind of Poultry)," as defined
in Sec. 381.173 of this chapter, in the preparation of meat food
products shall accord with Sec. 381.174 and all other applicable
provisions of this subchapter.
[35 FR 15586, Oct. 3, 1970, as amended at 38 FR 14368, June 1, 1973; 38
FR 29214, Oct. 23, 1973; 39 FR 1973, Jan. 16, 1974; 41 FR 23702, June
11, 1976; 49 FR 19623, May 9, 1984; 50 FR 6, Jan. 2, 1985; 60 FR 55982,
Nov. 3, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR318.8]
[Page 237-238]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.8 Preservatives and other substances permitted in product for export only; handling; such product not to be used for domestic food purposes.
(a) Preservatives and other substances not permitted in domestic
product under the regulations in this subchapter may be used in the
preparation and packing of product intended for export provided the
product (1) accords to the specifications or directions of the foreign
purchaser; (2) is not in conflict with the laws of the country to which
it is intended for export; and (3) is labeled on the outside container
to show that it is intended for export, and is otherwise labeled as
required by this subchapter for such export product.
(b) The preparation and packing of export product as provided for in
paragraph (a) of this section shall be done in a manner acceptable to
the inspector in charge so that the identity of the export product is
maintained conclusively and the preparation of domestic product is
adequately protected. The preservatives and other substances not
permitted in domestic product shall be stored in a room or compartment
separate from areas used to store other supplies and shall be held under
Program lock. Use of the preservatives or other substances shall be
under the direct supervision of a Program employee.
(c) The packing of all articles under paragraph (a) of this section
shall be conducted under the direct supervision of a Program employee.
(d) No article prepared or packed for export under paragraph (a) of
this section shall be sold or offered for sale for domestic use or
consumption, but unless exported shall be destroyed for food purposes
under the direct supervision of a Program employee.
(e) The contents of the container of any article prepared or packed
for export under paragraph (a) of this section shall not be removed, in
whole or in part, from such container prior to exportation, except under
the supervision of a Program employee. If such contents are removed
prior to exportation, then the article shall be either repacked, in
accordance with the provisions of paragraphs (b) and (c) of this
[[Page 238]]
section, or destroyed for food purposes under the direct supervision of
a Program employee.
(f) Permission must be obtained from the Administrator before meats
packed in borax are shipped from one official establishment to another
or to an unofficial establishment for storage, except such meat prepared
for the account of Federal agencies.
(g) At all times, the identity of meat to which borax has been added
shall be effectively maintained. In no case shall such meat, nor any
trimmings or fat derived from such meat, whether unwashed or washed, or
otherwise treated, be diverted to domestic use.
(h) Salt used for bulking meat previously packed in borax may not
again be used in an edible products department other than in connection
with the packing of meat in borax. Only metal equipment should be used
for handling such meat. Particularly effective cleansing will be
required if wooden equipment such as trucks, washing vats, etc., is
used. Boxes from which boraxed meat has been removed may be used for
repacking meat in borax, but their use as containers for other meat will
be dependent upon the effective removal of all traces of borax.
(i) The following instructions pertain to export cured pork packed
in borax for the account of Federal agencies. The meat may be packed in
borax in a room in which there is borax-free meat, provided proper care
is taken to see that the borax-free meat is not affected by the borax.
Under the same condition, meat packed in borax may be received,
unpacked, defrosted, soaked, washed, smoked, and repacked in a room
where there is other meat. However, meat originally packed in borax
shall at all times be subject to the restrictions of meat so packed,
even though repacked without borax. After packing or repacking, borax
packed meat may be stored in a room with meat not packed in borax,
provided a reasonable degree of separation is maintained between the two
classes of product.
[35 FR 15586, Oct. 3, 1970; 36 FR 11903, June 23, 1971, as amended at 38
FR 29214, Oct. 23, 1973]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR318.9]
[Page 238]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.9 Samples of products, water, dyes, chemicals, etc., to be taken for examination.
Samples of products, water, dyes, chemicals, preservatives, spices,
or other articles in any official establishment shall be taken, without
cost to the Program, for examination, as often as may be deemed
necessary for the efficient conduct of the inspection.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR318.10]
[Page 238-248]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.10 Prescribed treatment of pork and products containing pork to destroy trichinae.
(a)(1) All forms of fresh pork, including fresh unsmoked sausage
containing pork muscle tissue, and pork such as bacon and jowls, other
than those covered by paragraph (b) of this section, are classed as
products that are customarily well cooked in the home or elsewhere
before being served to the consumer. Therefore, the treatment of such
products for the destruction of trichinae is not required.
(2) Pork from carcasses or carcass parts that have been found free
of trichinae as described under paragraph (e) or (f) of this section is
not required to be treated for the destruction of trichinae.
(b) Products named in this paragraph, and products of the character
hereof, containing pork muscle tissue (not including pork hearts, pork
stomachs, and pork livers), or the pork muscle tissue which forms an
ingredient of such products, shall be effectively heated, refrigerated,
or cured to destroy any possible live trichinae, as prescribed in this
section at the official establishment where such products are prepared:
Bologna, frankfurter, vienna, and other cooked sausage; smoked sausage;
knoblauch sausage; mortadella; all forms of summer or dried sausage,
including mettwurst; flavored pork sausages such as those containing
wine or similar flavoring materials; cured pork sausage; sausage
containing cured and/or smoked pork; cooked loaves; roasted, baked,
boiled, or cooked hams, pork shoulders, or pork shoulder picnics;
Italian-style hams; Westphalia-style hams; smoked boneless pork shoulder
butts; cured meat rolls; capocollo (capicola, capacola); coppa; fresh or
cured boneless pork shoulder butts, hams, loins, shoulders, shoulder
[[Page 239]]
picnics, and similar pork cuts, in casings or other containers in which
ready-to-eat delicatessen articles are customarily enclosed (excepting
Scotch-style hams); breaded pork products; cured boneless pork loins;
boneless back bacon; bacon used for wrapping around patties, steaks and
similar products; and smoked pork cuts such as hams, shoulders, loins,
and pork shoulder picnics (excepting smoked hams, and smoked pork
shoulder picnics which are specially prepared for distribution in
tropical climates or smoked hams delivered to the Armed Services);
ground meat mixtures containing pork and beef, veal, lamb, mutton, or
goat meat and other product consisting of mixtures of pork and other
ingredients, which the Administrator determines at the time the labeling
for the product is submitted for approval in accordance with part 317 of
the regulations in this subchapter or upon subsequent reevaluation of
the product, would be prepared in such a manner that the product might
be eaten rare or without thorough cooking because of the appearance of
the finished product or otherwise. Cured boneless pork loins shall be
subjected to prescribed treatment for destruction of trichinae prior to
being shipped from the establishment where cured.
(c) The treatment shall consist of heating, refrigerating, or
curing, as follows:
(1) Heating. (i) All parts of the pork muscle tissue shall be heated
according to one of the time and temperature combinations in the
following table:
------------------------------------------------------------------------
Minimum internal temperature
--------------------------------------------------
Degrees Minimum time
Degrees fahrenheit centigrade
------------------------------------------------------------------------
120.................................. 49.0 21 hours.
122.................................. 50.0 9.5 hours.
124.................................. 51.1 4.5 hours.
126.................................. 52.2 2 hours.
128.................................. 53.4 1 hour.
130.................................. 54.5 30 minutes.
132.................................. 55.6 15 minutes.
134.................................. 56.7 6 minutes.
136.................................. 57.8 3 minutes.
138.................................. 58.9 2 minutes.
140.................................. 60.0 1 minute.
142.................................. 61.1 1 minute.
144.................................. 62.2 Instant.
------------------------------------------------------------------------
(ii) Time and temperature shall be monitored by a calibrated
recording instrument that meets the requirements of paragraph (d) of
this section, except for paragraph (c)(1)(iv).
(iii) The time to raise product temperature from 60 deg.F. to 120
deg.F shall not exceed 2 hours unless the product is cured or fermented.
(iv) Time, in combination with temperatures of 138 deg.F to 143
deg.F, need not be monitored if the product's minimum thickness exceeds
2 inches (5.1 cm) and refrigeration of the product does not begin within
5 minutes of attaining 138 deg.F (58.9 deg.C).
(v) The establishment shall use procedures which insure the proper
heating of all parts of the product. It is important that each piece of
sausage, each ham, and other product treated by heating in water be kept
entirely submerged throughout the heating period; and that the largest
pieces in a lot, the innermost links of bunched sausage or other massed
articles, and pieces placed in the coolest part of a heating cabinet or
compartment or vat be included in the temperature tests.
(2) Refrigerating. At any stage of preparation and after preparatory
chilling to a temperature of not above 40 deg.F. or preparatory
freezing, all parts of the muscle tissue of pork or product containing
such tissue shall be subjected continuously to a temperature not higher
than one of those specified in table 1, the duration of such
refrigeration at the specified temperature being dependent on the
thickness of the meat or inside dimensions of the container.
Table 1--Required Period of Freezing at Temperature Indicated
------------------------------------------------------------------------
Temperature deg.F. Group 1 (Days) Group 2 (Days)
------------------------------------------------------------------------
5 20 30
-10 10 20
-20 6 12
------------------------------------------------------------------------
(i) Group 1 comprises product in separate pieces not exceeding 6
inches in thickness, or arranged on separate racks with the layers not
exceeding 6 inches in depth, or stored in crates or boxes not exceeding
6 inches in depth, or stored as solidly frozen blocks not exceeding 6
inches in thickness.
(ii) Group 2 comprises product in pieces, layers, or within
containers, the thickness of which exceeds 6 inches but
[[Page 240]]
not 27 inches, and product in containers including tierces, barrels,
kegs, and cartons having a thickness not exceeding 27 inches.
(iii) The product undergoing such refrigeration or the containers
thereof shall be so spaced while in the freezer as will insure a free
circulation of air between the pieces of meat, layers, blocks, boxes,
barrels, and tierces in order that the temperature of the meat
throughout will be promptly reduced to not higher than 5 deg.F., -10
deg.F., or -20 deg.F., as the case may be.
(iv) In lieu of the methods prescribed in Table 1, the treatment may
consist of commercial freeze drying or controlled freezing, at the
center of the meat pieces, in accordance with the times and temperatures
specified in Table 2.
Table 2--Alternate Periods of Freezing at Temperatures Indicated
------------------------------------------------------------------------
Maximum internal temperature
--------------------------------------------------
Degrees Minimum Time
Degrees Fahrenheit centigrade
------------------------------------------------------------------------
0.................................. -17.8 106 hours.
-5................................... -20.6 82 hours.
-10.................................. -23.3 63 hours.
-15.................................. -26.1 48 hours.
-20.................................. -28.9 35 hours.
-25.................................. -31.7 22 hours.
-30.................................. -34.5 8 hours.
-35.................................. -37.2 \1/2\ hour.
------------------------------------------------------------------------
(v) During the period of refrigeration the product shall be kept
separate from other products and in the custody of the Program in rooms
or compartments equipped and made secure with an official Program lock
or seal. The rooms or compartments containing product undergoing
freezing shall be equipped with accurate thermometers placed at or above
the highest level at which the product undergoing treatment is stored
and away from refrigerating coils. After completion of the prescribed
freezing of pork to be used in the preparation of product covered by
paragraph (b) of this section the pork shall be kept under close
supervision of an inspector until it is prepared in finished form as one
of the products enumerated in paragraph (b) of this section or until it
is transferred under Program control to another official establishment
for preparation in such finished form.
(vi) Pork which has been refrigerated as specified in this
subparagraph may be transferred in sealed railroad cars, sealed
motortrucks, sealed trailers, or sealed closed containers to another
official establishment at the same or another location, for use in the
preparation of product covered by paragraph (b) of this section. Such
vehicles and containers shall be sealed and transported between official
establishments in accordance with Sec. 325.7 of this subchapter.
(3) Curing--(i) Sausage. The sausage may be stuffed in animal
casings, hydrocellulose casings, or cloth bags. During any stage of
treating the sausage for the destruction of live trichinae, except as
provided in Method 5, these coverings shall not be coated with paraffin
or like substance, nor shall any sausage be washed during any prescribed
period of drying. In the preparation of sausage, one of the following
methods may be used:
Method No. 1. The meat shall be ground or chopped into pieces not
exceeding three-fourths of an inch in diameter. A dry-curing mixture
containing not less than 3\1/3\ pounds of salt to each hundredweight of
the unstuffed sausage shall be thoroughly mixed with the ground or
chopped meat. After being stuffed, sausage having a diameter not
exceeding 3\1/2\ inches, measured at the time of stuffing, shall be held
in a drying room not less than 20 days at a temperature not lower than
45 deg.F., except that in sausage of the variety known as pepperoni, if
in casings not exceeding 1\3/8\ inches in diameter measured at the time
of stuffing, the period of drying may be reduced to 15 days. In no case,
however, shall the sausage be released from the drying room in less than
25 days from the time the curing materials are added, except that
sausage of the variety known as pepperoni, if in casings not exceeding
the size specified, may be released at the expiration of 20 days from
the time the curing materials are added. Sausage in casings exceeding
3\1/2\ inches, but not exceeding 4 inches, in diameter at the time of
stuffing, shall be held in a drying room not less than 35 days at a
temperature not lower than 45 deg.F., and in no case shall the sausage
be released from the drying room in less than 40 days from the time the
curing materials are added to the meat.
Method No. 2. The meat shall be ground or chopped into pieces not
exceeding three-fourths of an inch in diameter. A dry-curing mixture
containing not less than 3\1/3\ pounds of salt to each hundredweight of
the unstuffed sausage shall be thoroughly mixed
[[Page 241]]
with the ground or chopped meat. After being stuffed, sausage having a
diameter not exceeding 3\1/2\ inches, measured at the time of stuffing,
shall be smoked not less than 40 hours at a temperature not lower than
80 deg.F., and finally held in a drying room not less than 10 days at a
temperature not lower than 45 deg.F. In no case, however, shall the
sausage be released from the drying room in less than 18 days from the
time the curing materials are added to the meat. Sausage exceeding 3\1/
2\ inches, but not exceeding 4 inches, in diameter at the time of
stuffing, shall be held in a drying room, following smoking as above
indicated, not less than 25 days at a temperature not lower than 45
deg.F., but in no case shall the sausage be released from the drying
room in less than 33 days from the time the curing materials are added
to the meat.
Method No. 3. The meat shall be ground or chopped into pieces not
exceeding three-fourths of an inch in diameter. A dry-curing mixture
containing not less than 3\1/3\ pounds of salt to each hundredweight of
the unstuffed sausage shall be thoroughly mixed with the ground or
chopped meat. After admixture with the salt and other curing materials
and before stuffing, the ground or chopped meat shall be held at a
temperature not lower than 34 deg.F. for not less than 36 hours. After
being stuffed, the sausage shall be held at a temperature not lower than
34 deg.F. for an additional period of time sufficient to make a total
of not less than 144 hours from the time the curing materials are added
to the meat, or the sausage shall be held for the time specified in a
pickle-curing medium of not less than 50 deg. strength (salometer
reading) at a temperature not lower than 44 deg.F. Finally, sausage
having a diameter not exceeding 3\1/2\ inches, measured at the time of
stuffing, shall be smoked for not less than 12 hours. The temperature of
the smokehouse during this period at no time shall be lower than 90
deg.F.; and for 4 consecutive hours of this period the smokehouse shall
be maintained at a temperature not lower than 128 deg.F. Sausage
exceeding 3\1/2\ inches, but not exceeding 4 inches, in diameter at the
time of stuffing shall be smoked, following the prescribed curing, for
not less than 15 hours. The temperature of the smokehouse during the 15-
hour period shall at no time be lower than 90 deg.F., and for 7
consecutive hours of this period the smokehouse shall be maintained at a
temperature not lower than 128 deg.F. In regulating the temperature of
the smokehouse for the treatment of sausage under this method, the
temperature of 128 deg.F. shall be attained gradually during a period
of not less than 4 hours.
Method No. 4. The meat shall be ground or chopped into pieces not
exceeding one-fourth of an inch in diameter. A dry-curing mixture
containing not less than 2\1/2\ pounds of salt to each hundredweight of
the unstuffed sausage shall be thoroughly mixed with the ground or
chopped meat. After admixture with the salt and other curing materials
and before stuffing, the ground or chopped sausage shall be held as a
compact mass, not more than 6 inches in depth, at a temperature not
lower than 36 deg.F. for not less than 10 days. At the termination of
the holding period, the sausage shall be stuffed in casings or cloth
bags not exceeding 3\1/3\ inches in diameter, measured at the time of
stuffing. After being stuffed, the sausage shall be held in a drying
room at a temperature not lower than 45 deg.F. for the remainder of a
35-day period, measured from the time the curing materials are added to
the meat. At any time after stuffing, if the establishment operator
deems it desirable, the product may be heated in a water bath for a
period not to exceed 3 hours at a temperature not lower than 85 deg.F.,
or subjected to smoking at a temperature not lower than 80 deg.F., or
the product may be both heated and smoked as specified. The time
consumed in heating and smoking, however, shall be in addition to the
35-day holding period specified.
Method No. 5. The meat shall be ground or chopped into pieces not
exceeding three-fourths of an inch in diameter. A dry-curing mixture
containing not less than 3\1/3\ pounds of salt to each hundredweight of
the unstuffed sausage shall be thoroughly mixed with the ground or
chopped meat. After being stuffed, the sausage shall be held for not
less than 65 days at a temperature not lower than 45 deg.F. The
coverings for sausage prepared according to this method may be coated at
any stage of the preparation before or during the holding period with
paraffin or other substance approved by the Administrator.
Method No. 6. (A) Basic requirements. The meat shall be ground or
chopped into pieces not exceeding three-fourths of an inch in diameter.
A dry-curing mixture containing not less than 3.33 pounds of salt to
each hundredweight of the unstuffed sausage, excluding the weight of dry
ingredients, shall be thoroughly mixed with the ground or chopped meat.
After the curing mixture has been added, the sausage shall be held for
two time periods, a holding period and a drying period. The holding
period will be for a minimum of 48 hours at a room temperature not lower
than 35 deg.F. This holding period requirement may be fulfilled totally
or in part before the drying period and then the remainder, if any,
after the drying period or as an extension of the drying period. During
the drying period, the sausage shall be held in a drying room at a
temperature not lower than 50 (10.0 deg.F. (10.0 deg.C) for a period
of time determined by Tables 3A, 3B, and 4. The length of the drying
period, established in (c)(3)(i)(A), may be modified as provided in
paragraphs (c)(3)(i)(B) and (c)(3)(i)(C) of this section.
[[Page 242]]
Table 3A--Sausage Drying Room Times by Method No. 6
------------------------------------------------------------------------
Days in
Diameter of casing at time of stuffing\1\ drying
room\2\
------------------------------------------------------------------------
Up to:
1 inches................................................... 14
1\1/2\ inches.............................................. 15
2 inches................................................... 16
2\1/2\ inches.............................................. 18
3 inches................................................... 20
3\1/2\ inches.............................................. 23
4 inches................................................... 25
4\1/2\ inches.............................................. 30
5 inches................................................... 35
5\1/2\ inches.............................................. 43
6 inches................................................... 50
------------------------------------------------------------------------
\1\ The drying room times for flattened or oval sausages shall use a
diameter derived by measuring the circumference and dividing by 3.14
(pi).
\2\ Drying room time may be modified as set forth in Tables 3B and 4.
(B) Reduction in Drying Room Time. During the holding period, the
sausage may be smoked or fermented. If the temperature is increased to
70 deg.F. (21.1 deg.C) or higher, while the sausage is being held
after adding curing materials but before the drying period, the
subsequent drying room times prescribed for this method may be reduced
according to the schedule in Table 3B. No interpolation of values is
permissible.
Table 3B--Percentage Reduction in Drying Room Time (Table 3A) Permitted by Holding Times and Temperatures Prior to Drying \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Minimum Temperature \2\
---------------------------------------------------------------------------------------------------
70 75 80 85 90 95 100 105 110 120
Minimum Time deg.F deg.F deg.F deg.F deg.F deg.F deg.F deg.F deg.F deg.F
---------------------------------------------------------------------------------------------------
21.1 23.9 26.7 29.5 32.2 35.0 37.9 40.6 43.3 48.9
deg.C deg.C deg.C deg.C deg.C deg.C deg.C deg.C deg.C deg.C
--------------------------------------------------------------------------------------------------------------------------------------------------------
24 hours............................................ 4 5 8 10 15 23 37 57 90 \3\ 100
48 hours............................................ 9 12 18 25 35 49 88 \3\ 100 \3\ 100 100
72 hours............................................ 14 19 28 39 55 74 \3\ 100 100 100 100
96 hours............................................ 19 26 38 53 75 98 100 100 100 100
120 hours........................................... 24 33 48 67 95 \3\ 100 100 100 100 100
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ In computing the days to be deducted, the number with any fraction shall be rounded to the next lower whole number and shall be deducted from the
required total drying time. Example: Sausage stuffed in 3 diameter casing requires 20 days in the drying room (from Drying Room Times,
Table 3A). If allowed to ferment, after addition of curing materials, at 80 deg.F. for 48 hours, the 20 day drying time may be reduced 18% (from
Table 3B). Eighteen percent of 20 day equals 3.6 days. Twenty days minus 3 days equals 17 days. The total drying time required in the drying room,
therefore, will be 17 days.
\2\ Either room temperature or internal product temperature shall be used for sausages that will be subsequently dried to a moisture-protein ratio of
2.3:1 or less. Internal product temperature shall be used for all other sausages.
\3\ Trichinae will be destroyed during fermentation or smoking at the temperature and length of time indicated. Therefore, no drying room period is
required for products so treated.
(C) Reduced Salt Content--Drying Room Times. Salt content of less
than 3.33 pounds for each hundredweight of sausage formulation,
excluding dry ingredients, (such as salts, sugars, and spices), may be
permitted provided the drying time is increased according to the
schedule contained in Table 4.
Trichina Treatment of Sausage by Method No. 6;
Table 4--Reduced Salt Content--Drying Room Times
[Required percentage increase in drying room time (table 3A) for added
salt of less than 3.33 pounds per hundredweight of sausage]
------------------------------------------------------------------------
Increase
in drying
Minimum pounds of salt added to sausage \1\ room time
\2\
------------------------------------------------------------------------
3.3.......................................................... 1
3.2.......................................................... 4
3.1.......................................................... 7
3.0.......................................................... 10
2.9.......................................................... 13
2.8.......................................................... 16
2.7.......................................................... 19
2.6.......................................................... 22
2.5.......................................................... 25
2.4.......................................................... 28
2.3.......................................................... 31
2.2.......................................................... 34
2.1.......................................................... 37
2.0.......................................................... 40
------------------------------------------------------------------------
\1\ Calculate the salt content for column 1 as follows: Multiply the
pounds of salt in the sausage formulation by 100. Then divide this
number by the total weight of sausage formulation minus the weight of
dry ingredients and round down to the next lowest 0.1%. Percents may
be substituted for pounds.
Example: 120 lbs. pork, 3.56 lbs. salt, 2 lbs. spices, 0.5 lbs. wine, 1
lb. water and starter culture, 0.8 lbs. sugar, .012 lbs. sodium
nitrite total weight is 127.872 lbs.
[[Page 243]]
(3.56x100)/(127.872-3.56-2-.8-.012)=356/121.5=2.93
Therefore, the sausage drying time must be increased by 13 percent.
\2\ In computing the days to be added to the required total drying time,
fractions shall be rounded to the next higher whole number and added
to the required total drying time. Example: Sausage stuffed in 3\1/2\
inch diameter casing requires 23 days in the drying room (from Drying
Room Times). If the quantity of salt added per hundredweight of
sausage is 2 pounds instead of 3.33 pounds, the drying room time must
be increased by 40 percent (from Reduced Salt Content-Drying Room
Times), or 9.2 days. The 9.2 is rounded up to 10 days and is added to
the 23 days to equal 33 days. The total drying time required in the
drying room, therefore, will be 33 days.
Method No. 7, Dry Sausages. (A) General Requirements. The
establishment shall use meat particles reduced in size to no more than
1/4 inch in diameter. The establishment shall add a curing mixture
containing no less than 2.7 pounds of salt per hundred pounds of meat
and mix it uniformly throughout the product. The establishment shall
hold, heat, and dry the product according to paragraph (B) or (C) below.
(B) Holding, Heating, and Drying Treatment, Large Sausages. Except
as permitted in (C) below, the establishment shall subject sausages in
casings not exceeding 105 mm in diameter, at the time of stuffing, to
all of the following minimum chamber temperatures and time periods.
Treatment Schedule for Sausages 105 Millimeters (4\1/8\ Inches) or Less
in Diameter
------------------------------------------------------------------------
Minimum chamber temperature
------------------------------------------------- Minimum time (hours)
( deg.F) ( deg.C)
------------------------------------------------------------------------
50 10 12
90 32.2 1
100 37.8 1
110 43.3 1
120 48.9 1
125 51.7 7
------------------------------------------------------------------------
Following the preceding treatment, the establishment shall dry the
sausages at a temperature not lower than 50 deg.F (10 deg.C) for not
less than 7 days.
(C) Heating and Drying Treatment, Small Sausages. Alternatively, the
establishment may subject sausages in casings not exceeding 55 mm in
diameter, at the time of stuffing, to all of the following minimum
chamber temperatures and time periods.
Treatment Schedule for Sausages 55 Millimeters (2\1/8\ Inches) or Less
in Diameter
------------------------------------------------------------------------
Minimum chamber temperature
------------------------------------------------- Minimum time (hours)
( deg.F) ( deg.C)
------------------------------------------------------------------------
50 10 12
100 37.8 1
125 51.7 6
------------------------------------------------------------------------
Following the preceding heat treatment, the establishment shall dry the
sausages at a temperature not lower than 50 deg.F (10 deg.C) for not
less than 4 days.
(ii) Capocollo (capicola, capacola). Boneless pork butts for
capocollo shall be cured in a dry-curing mixture containing not less
than 4\1/2\ pounds of salt per hundredweight of meat for a period of not
less than 25 days at a temperature not lower than 36 deg.F. If the
curing materials are applied to the butts by the process known as
churning, a small quantity of pickle may be added. During the curing
period the butts may be overhauled according to any of the usual
processes of overhauling, including the addition of pickle or dry salt
if desired. The butts shall not be subjected during or after curing to
any treatment designed to remove salt from the meat, except that
superficial washing may be allowed. After being stuffed, the product
shall be smoked for a period of not less than 30 hours at a temperature
not lower than 80 deg.F., and shall finally be held in a drying room
not less than 20 days at a temperature not lower than 45 deg.F.
(iii) Coppa. Boneless pork butts for coppa shall be cured in a dry-
curing mixture containing not less than 4\1/2\ pounds of salt per
hundredweight of meat for a period of not less than 18 days at a
temperature not lower than 36 deg.F. If the curing mixture is applied
to the butts by the process known as churning, a small quantity of
pickle may be added. During the curing period the butts may be
overhauled according to any of the usual processes of overhauling,
including the addition of pickle or dry salt if desired. The butts shall
not be subjected during or after curing to any treatment designed to
remove salt from the meat, except that superficial washing may be
allowed. After being stuffed, the product shall be held in a drying room
not less than 35 days at a temperature not lower than 45 deg.F.
(iv) Hams and pork shoulder picnics. In the curing of hams and pork
shoulder picnics, one of the methods below shall be used. For
calculating days per pound, the establishment shall use the weight of
the heaviest ham or picnic in the lot.
Method No. 1. The hams and pork shoulder picnics shall be cured by a
dry-salt curing process not less than 40 days at a temperature no lower
than 36 deg.F. The products shall
[[Page 244]]
be laid down in salt, not less than 4 pounds to each hundredweight of
product, the salt being applied in a thorough manner to the lean meat of
each item. When placed in cure, the products may be pumped with pickle
if desired. At least once during the curing process, the products shall
be overhauled (turned over for the application of additional cure) and
additional salt applied, if necessary, so that the lean meat of each
item is thoroughly covered. After removal from cure, the products may be
soaked in water at a temperature not higher than 70 deg.F for not more
than 15 hours, during which time the water may be changed once, but they
shall not be subjected to any other treatment designed to remove salt
from the meat except that superficial washing may be allowed. The
products shall finally be dried or smoked at a time and temperature not
less than a combination prescribed in Table 5 of Method No. 3.
Method No. 2. [Reserved]
Method No. 3. (A) Curing. (Other than bag curing): Establishments
shall cure hams and shoulders by using a cure mixture containing not
less than 70 percent salt by weight to cover all exposed muscle tissue
and to pack the hock region. Total curing time consists of a mandatory
cure contact time and an optional equalization time.
(B) Cure Contact Time. This is the cure contact period, during which
the establishment shall keep exposed muscle tissue coated with the cure
mixture at least 28 days but for no less than 1.5 days per pound of ham
or shoulder. Overhaul is optional so long as the exposed muscle tissue
remains coated with curing mixture.
(C) Equalization. The establishment may provide an equalization
period after the minimum cure contact period in (B) above to permit the
absorbed salt to permeate the product's inner tissues. Equalization is
the time after the excess cure has been removed from the product at the
end of the cure contact period until the product is placed in the drying
room and the drying period begins. The total curing time (equalization
plus cure contact) shall be at least 40 days and in no case less than 2
days per pound of an uncured ham or shoulder.
(D) Removing Excess Cure. After the required cure contact period,
the establishment may remove excess cure mixture from the product's
surface mechanically or by rinsing up to 1 minute with water, but not by
soaking.
(E) Bag Curing. Bag curing is a traditional ham curing technique in
which the manufacturer wraps the ham and all of the cure mixture
together in kraft paper then hangs them individually. The paper keeps
the extra cure mixture in close contact with the product making
reapplication of salt unnecessary, and it protects the product from
mites and insects. Establishments may employ the bag curing method as an
alternative to (A) through (D) above. An establishment which elects to
use the bag curing method shall apply a cure mixture containing at least
6 pounds of salt per 100 pounds of uncured product. The establishment
shall rub the curing mixture into the exposed muscle tissue, pack the
hock region with the curing mixture, and use uncoated wrapping paper to
wrap the product together with any remaining curing mixture. The bag
cured product shall remain wrapped throughout the curing period and may
or may not remain wrapped during the drying period. In any case, the
curing period shall be at least 40 days but not less than 2 days per
pound of an uncured ham or shoulder. After curing, the cured product
shall be exposed to a drying time and temperature prescribed in Table 5.
(F) Curing Temperature. During the curing period the establishment
shall use one of the following procedures:
(1) The establishment shall control the room temperature at not less
than 35 deg.F (1.7 deg.C) nor greater than 45 deg.F (7.2 deg.C) for
the first 1.5 days per pound of an uncured ham or shoulder, and not less
than 35 deg.F (1.7 deg.C) nor greater than 60 deg.F (15.6 deg.C) for
the remainder of the curing period.
(2) The establishment shall monitor and record daily product
temperature. The room temperature need not be controlled but days on
which the product temperature drops below 35 deg.F (1.7 deg.C) shall
not be counted as curing time. If the product temperature exceeds 45
deg.F (7.2 deg.C) within the first period of 1.5 days per pound of an
uncured ham or shoulder or if it exceeds 60 deg.F (15.6 deg.C) for the
remainder of the curing period, the establishment shall cool the product
back to the 45 deg.F (7.2 deg.C) maximum during the first period or 55
deg.F (12.8 deg.C) maximum during the remainder of the period.
(3) The establishment shall begin curing product only between the
dates of December 1 and February 13. The room temperature need not be
controlled, but the establishment shall monitor and record daily room
temperatures, and days in which the room temperature drops below 35
deg.F (1.7 deg.C) shall not be counted as curing time.
(G) Drying. After the curing period, establishments shall use one of
three procedures for drying:
(1) The establishment shall subject the product to a controlled room
temperature for a minimum time and minimum temperature combination
prescribed in Table 5 or for a set of such combinations in which the
total of the fractional periods (in column 4 of Table 5) exceeds 1.5.
(2) Establishments using uncontrolled room temperatures shall
monitor and record the internal product temperature. The drying period
shall be complete when, from the days which can be counted as curing
time, one of the time/temperature combinations of
[[Page 245]]
Table 5 is satisfied or when the total of the fractional values for the
combinations exceeds 1.5.
(3) Establishments using uncontrolled room temperatures shall dry
the product for a minimum of 160 days including the entire months of
June, July, and August. This procedure is obviously dependent on local
climatic conditions and no problem exists with respect to current
producers who use this procedure. Future applicants shall demonstrate
that their local monthly average temperatures and the local monthly
minimum temperatures are equal to or warmer than the normal average
temperatures and normal minimum temperatures compiled by the National
Oceanic and Atmospheric Administration for Boone, North Carolina,
station 31-0977, 1951 through 1980.
Monthly Temperatures ( deg.F) for Boone NC, 1951-1980
----------------------------------------------------------------------------------------------------------------
Jan. Feb. Mar. Apr. May June July Aug. Sep.
----------------------------------------------------------------------------------------------------------------
Normal average temperatures
----------------------------------------------------------------------------------------------------------------
32.2 34.1 41.3 51.2 59.1 65.1 68.3 67.5 61.6
----------------------------------------------------------------------------------------------------------------
Normal minimum temperatures
----------------------------------------------------------------------------------------------------------------
22.8 24.2 30.8 39.6 48.1 54.7 58.5 57.6 51.6
----------------------------------------------------------------------------------------------------------------
Drying Times and Temperatures for Trichina Inactivation in Hams and
Shoulders
Table 5--Minimum Drying Days at a Minimum Temperature*
------------------------------------------------------------------------
Minimum Drying Temperature Fractional
-------------------------------------------- Minimum days period for
Degrees at drying one day of
Degrees fahrenheit centigrade temperature drying
------------------------------------------------------------------------
130........................... 54.4 1.5 .67
125........................... 51.7 2 .50
120........................... 48.9 3 .33
115........................... 46.1 4 .25
110........................... 43.3 5 .20
105........................... 40.6 6 .17
100........................... 37.8 7 .14
95............................ 35.0 9 .11
90............................ 32.2 11 .091
85............................ 29.4 18 .056
80............................ 26.7 25 .040
75............................ 23.9 35 .029
------------------------------------------------------------------------
* Interpolation of these times or temperatures is not acceptable;
establishments wishing to use temperatures or times not in this Table
shall first validate their efficacy as provided by 318.10(c)(4) of
this section.
Method No. 4. (A) Cure: Establishments shall cure hams and shoulders
by using a cure mixture containing not less than 71.5 percent salt by
weight to cover all exposed muscle tissue and to pack the hock region.
Establishments may substitute potassium chloride (KCl) for up to half of
the required salt on an equal weight basis.
(B) Curing. Establishments shall apply the cure at a rate not less
than 5.72 pounds of salt and KCl per hundred pounds of fresh meat. The
cure shall be applied in either three or four approximately equal
amounts (two or three overhauls) at separate times during the first 14
days of curing.
(C) Cure Contact Time. Establishments shall keep the product in
contact with the cure mixture for no less than 2 days per pound of an
uncured ham or shoulder but for at least 30 days. Establishments shall
maintain the curing temperature at no less than 35 deg.F (1.7 deg.C)
during the cure contact time.
(D) Equalization. After the cure contact period, establishments
shall provide an added equalization period of no less than 1 day per
pound of an uncured ham or shoulder but at least 14 days. Equalization
is the time after the excess cure has been removed from the product, the
end of the cure contact period, and before the drying period begins.
Establishments may substitute additional cure contact days for an equal
number of equalization days.
(E) Removing Excess Cure. After the required cure contact period,
the establishment may remove excess cure mixture from the product's
surface mechanically or by rinsing up to 1 minute with water, but not by
soaking.
(F) Drying. After the curing period, establishments shall use one of
the controlled temperature methods for drying listed in Method No. 3 of
this subparagraph.
Method No. 5 (A) Curing. The establishment shall cure the ham to a
minimum brine concentration of 6 percent by the end of the drying
period. Brine concentration is calculated as 100 times the salt
concentration divided by the sum of the salt and water concentrations.
Percent brine = 100 x [salt] / ([salt] + [water])
The Agency will accept the brine concentration in the biceps femoris
as a reasonable estimate of the minimum brine concentration in the ham.
(B) Drying and Total Process Times. The establishment shall dry the
cured ham at a minimum temperature of 55 deg.F (13 deg.C) for at least
150 days. The total time of drying plus curing shall be at least 206
days.
[[Page 246]]
(C) Ensuring an Acceptable Internal Brine Concentration. (1) To
establish compliance, the establishment shall take product samples from
the first 12 lots of production as follows: From each lot,
(i) One sample shall be taken from each of 5 or more hams;
(ii) Each sample shall be taken from the biceps femoris. As an
alternative to the use of the biceps femoris, the Agency shall consider
other method(s) of sampling the dry-cured hams to determine the minimum
internal brine concentration, as long as the establishment proposes it
and submits data and other information to establish its sufficiency to
the Director of the Processed Products Inspection Division;
(iii) Each sample shall weigh no less than 100 grams;
(iv) The samples shall be combined as one composite sample and
sealed in a water vapor proof container;
(v) The composite sample shall be submitted to a laboratory
accredited under the provisions of Sec. 318.21 to be analyzed for salt
and water content using methods from the "Official Methods of Analysis
of the Association of Official Analytical Chemists (AOAC)," 15th
Edition, 1990, Section 983.18 (page 931) and Section 971.19 (page 933)
which are incorporated by reference. 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 obtained from the
Association of Official Analytical Chemists, suite 400-BW, 2200 Wilson
Boulevard, Arlington, VA 22201-3301. Copies may be inspected at the
Office of the FSIS Hearing Clerk, room 3171, South Agriculture Building,
Food Safety and Inspection Service, U.S. Department of Agriculture,
Washington, DC 20250 or at the Office of the Federal Register, 800 North
Capitol Street, NW., suite 700, Washington, DC 20408. If the time
between sampling and submittal of the composite sample to the accredited
laboratory will exceed 8 hours, then the establishment shall freeze the
composite sample immediately after the samples are combined;
(vi) Once the laboratory results for the composite sample are
received, the manufacturer shall calculate the internal brine
concentration by multiplying the salt concentration by 100 and then
dividing that figure by the sum of the salt and water concentrations;
(vii) Compliance is established when the samples from the first 12
lots of production have a minimum internal brine concentration of 6
percent. Lots being tested to establish compliance shall be held until
the internal brine concentration has been determined and found to be at
least 6 percent. If the minimum internal brine concentration is less
than 6 percent, the lot being tested shall be held until the
establishment brings the lot into compliance by further processing.
(2) To maintain compliance, the establishment shall take samples,
have the samples analyzed, and perform the brine calculations as set
forth above from one lot every 13 weeks. Lots being tested to maintain
compliance shall not be held. If the minimum internal brine
concentration is less than 6 percent in a lot being tested to maintain
compliance, the establishment shall develop and propose steps acceptable
to FSIS to ensure that the process is corrected.
(3) Accredited laboratory results and the brine calculations shall
be placed on file at the establishment and available to Program
employees for review.
Method No. 6 (A) Curing. The establishment shall cure the ham to a
minimum brine concentration of 6 percent by the end of the drying
period. Brine concentration is calculated as 100 times the salt
concentration divided by the sum of the salt and water concentrations.
Percent brine = 100 x [salt] / ([salt] + [water])
The Agency will accept the brine concentration in the biceps femoris
as a reasonable estimate of the minimum brine concentration.
(B) Drying and Total Process Times. The establishment shall dry the
cured ham at a minimum temperature of 110 deg.F (43 deg.C) for at
least 4 days. The total time of drying plus curing shall be at least 34
days.
(c) Ensuring an Acceptable Internal Brine Concentration.
(1) To establish compliance the establishment shall take product
samples from the first 12 lots of production as follows: From each lot,
(i) One sample shall be taken from each of 5 or more hams;
(ii) Each sample shall be taken from the biceps femoris. As an
alternative to the use of the biceps femoris, the Agency will consider
other methods of sampling the dry-cured hams to determine internal brine
concentration, as long as the establishment proposes it and submits data
and other information to establish its sufficiency to the Director of
the Processed Products Inspection Division;
(iii) Each sample shall weigh no less than 100 grams;
(iv) The samples shall be combined as one composite sample and
sealed in a water vapor proof container;
(v) The composite sample shall be submitted to a laboratory
accredited under the provisions of Sec. 318.21 to be analyzed for salt
and water content using methods from the "Official Methods of Analysis
of the Association of Official Analytical Chemists (AOAC)," 15th
Edition, 1990, section 983.18 (page 931) and section 971.19 (page 933)
which are incorporated by reference. This incorporation by reference was
approved by the Director of the Federal Register in accordance
[[Page 247]]
with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the
Association of Official Analytical Chemists, suite 400-BW, 2200 Wilson
Boulevard, Arlington, VA 22201-3301. Copies may be inspected at the
Office of the FSIS Hearing Clerk, room 3171, South Agriculture Building,
Food Safety and Inspection Service, U.S. Department of Agriculture,
Washington, DC 20250 or at the Office of the Federal Register, 800 North
Capitol Street, NW., suite 700, Washington, DC. If the time between
sampling and submittal of the composite sample to the accredited
laboratory will exceed 8 hours, then the establishment shall freeze the
composite sample immediately after the samples are combined;
(vi) Compliance is established when the samples from the first 12
lots of production have a minimum internal brine concentration of 6
percent. Lots being tested to establish compliance shall be held until
the internal brine concentration has been determined and found to be at
least 6 percent. If the minimum internal brine concentration is less
than 6 percent, the lot being tested shall be held until the
establishment brings the lot into compliance by further processing.
(2) To maintain compliance, the establishment shall take samples,
have the samples analyzed, and perform the brine calculations as set
forth above from one lot every 13 weeks. Lots being tested to maintain
compliance shall not be held. If the minimum internal brine
concentration is less than 6 percent in a lot being tested to maintain
compliance, the establishment shall develop and propose steps acceptable
to FSIS to ensure that the process is corrected.
(3) Accredited laboratory results and the brine calculations shall
be placed on file in the establishment and available to Program
employees for review.
(v) Boneless pork loins and loin ends. In lieu of heating or
refrigerating to destroy possible live trichinae in boneless loins, the
loins may be cured for a period of not less than 25 days at a
temperature not lower than 36 deg.F. by the use of one of the following
methods:
Method No. 1. Application of a dry-salt curing mixture containing
not less than 5 pounds of salt to each hundredweight of meats.
Method No. 2. Application of a pickle solution of not less than
80 deg. strength (salometer) on the basis of not less than 60 pounds of
pickle to each hundredweight of meat.
Method No. 3. Application of a pickle solution added to the dry-salt
cure prescribed as Method No. 1 in this subdivision (v) provided the
pickle solution is not less than 80 deg. strength (salometer).
After removal from cure, the loins may be soaked in water for not
more than 1 hour at a temperature not higher than 70 deg.F. or washed
under a spray but shall not be subjected, during or after the curing
process, to any other treatment designed to remove salt.
Following curing, the loins shall be smoked for not less than 12
hours. The minimum temperature of the smokehouse during this period at
no time shall be lower than 100 deg.F., and for 4 consecutive hours of
this period the smokehouse shall be maintained at a temperature not
lower than 125 deg.F.
Finally, the product shall be held in a drying room for a period of
not less than 12 days at a temperature not lower than 45 deg.F.
(4) The Administrator shall consider additional processing methods
upon petition by manufacturers, and shall approve any such method upon
his/her determination that it can be properly monitored by an inspector
and that the safety of such methods is adequately documented by data
which has been developed by following an experimental protocol
previously reviewed and accepted by the Department.
(d) General instructions: When necessary to comply with the
requirements of this section, the smokehouses, drying rooms, and other
compartments used in the treatment of pork to destroy possible live
trichinae shall be suitably equipped, by the operator of the official
establishment, with accurate automatic recording thermometers. Circuit
supervisors are authorized to approve for use in sausage smokehouses,
drying rooms, and other compartments, such automatic recording
thermometers as are found to give satisfactory service and to disapprove
and require discontinuance of use, for purposes of the regulations in
this subchapter, any thermometers (including any automatic recording
thermometers) of the establishment that are found to be inaccurate or
unreliable.
(e) The requirements for using the pooled sample digestion technique
to analyze pork for the presence of trichina cysts are:
(1) The establishment shall submit for the approval of the Regional
Director its proposed procedure for identifying and pooling carcasses,
collecting and pooling samples, testing samples (including the name and
address of the laboratory), communicating test results, retesting
individual carcasses, and maintaining positive identification
[[Page 248]]
and clear separation of pork found to be trichina-free from untested
pork or trichina-positive pork.
(2) The establishment shall use the services of a laboratory
approved by the Administrator for all required testing. Such approval
shall be based on adequacy of facilities, reagents, and equipment, and
on demonstration of continuing competency and reliability in performing
the pooled sample digestion technique for trichinae.
(3) The establishment shall sample no less than 5 grams of diaphragm
muscle or tongue tissue from each carcass or no less than 10 grams of
other muscle tissue. Samples may be pooled but a pool shall not consist
of more than 100 grams of sample. Sampling and sample preparation are
subject to inspection supervision.
(4) Pork or products made from tested pork shall not be released as
trichina free from the official establishment without treatment until
the inspector in charge receives a laboratory report that the tested
pork is free of trichina cysts.
(f) Approval of other tests for trichinosis in pork. The
Administrator shall consider any additional analytical method for
trichinosis upon petition by a manufacturer, and may approve that method
upon the determination that it will detect at least 98 percent of swine
bearing cysts present at a tissue density equal to or less than one cyst
per gram of muscle from the diaphragm pillars at a 95 percent confidence
level. Any such petitions shall be supported by any data and other
information that the Administrator finds necessary. Notice of any
approval shall be given in the Federal Register, and the approved method
will be incorporated into this section.
[35 FR 15586, Oct. 3, 1970, as amended at 38 FR 31517; Nov. 15, 1973; 39
FR 40580, Nov. 19, 1974; 50 FR 5229, Feb. 7, l985; 50 FR 48075, Nov. 21,
1985; 52 FR 12517, Apr. 17, 1987; 57 FR 27874, June 22, 1992; 57 FR
33633, July 30, 1992; 57 FR 56440, Nov. 30, 1992]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR318.12]
[Page 248-249]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.12 Manufacture of dog food or similar uninspected article at official establishments.
(a) When dog food, or similar uninspected article is manufactured in
an edible product department, there shall be sufficient space allotted
and adequate equipment provided so that the manufacture of the
uninspected article in no way interferes with the handling or
preparation of edible products. Where necessary to avoid adulteration of
edible products, separate equipment shall be provided for the
uninspected article. To assure the maintenance of sanitary conditions in
the edible product departments, the operations incident to the
manufacture of the uninspected article will be subject to the same
sanitary requirements that apply to all operations in edible product
departments. The manufacture of the uninspected article shall be limited
to those hours during which the establishment operates under
inspectional supervision; and there shall be no handling, other than
receiving at the official establishment, of any of the product
ingredient of the uninspected article, other than during the regular
hours of inspection. The materials used in the manufacture of the
uninspected article shall not be used so as to interfere with the
inspection of edible product or the maintenance of sanitary conditions
in the department or render any edible product adulterated. The meat,
meat byproducts, and meat food product ingredients of the uninspected
article may be admitted into any edible products department of an
official establishment only if they are U.S. Inspected and Passed.
Products within Sec. 314.11 of this subchapter or parts of carcasses of
kinds not permitted under the regulations in this subchapter to be
prepared for human food (e.g., lungs or intestines), which are produced
at any official establishment, may be brought into the inedible products
department of any official establishment for use in uninspected articles
under this section. The uninspected article may be stored in, and
distributed from, edible product departments: Provided, That adequate
facilities are furnished, there is no interference with the maintenance
of sanitary conditions, and such article is properly identified.
(b) When dog food or similar uninspected article is manufactured in
a part of an official establishment other than an edible product
department, the area in which the article is
[[Page 249]]
manufactured shall be separated from edible product departments in the
manner required for separation between edible product departments and
inedible product departments. Sufficient space must be allotted and
adequate equipment provided so that the manufacture of the uninspected
article does not interfere with the proper functioning of the other
operations at the establishment. Except as provided in Sec. 314.11 of
this subchapter, nothing in this paragraph shall be construed as
permitting any deviation from the requirement that dead animals,
condemned products, and similar materials of whatever origin, must be
placed in the inedible product rendering equipment, and without undue
delay. The manufacture of the uninspected article must be such as not to
interfere with the maintenance of general sanitary conditions on the
premises, and it shall be subject to inspectional supervision similar to
that exercised over other inedible product departments. There shall be
no movement of any product from an inedible product department to any
edible product department. Trucks, barrels, and other equipment shall be
cleaned before being returned to edible product departments from
inedible product departments. Unoffensive material prepared outside
edible product departments may be stored in, and distributed from,
edible product departments only if packaged in clean, properly
identified, sealed containers.
(c) Animal food shall be distinguished from articles of human food,
so as to avoid distribution of such animal food as human food. To
accomplish this, such animal food shall be labeled or otherwise
identified in accordance with Sec. 325.11(d) of this subchapter.
[35 FR 15586, Oct. 3, 1970, as amended at 36 FR 11639, June 17, 1971; 53
FR 24679, June 30, 1988]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR318.13]
[Page 249]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.13 Mixtures containing product but not amendable to the Act.
Mixtures containing product but not classed as a meat food product
under the Act shall not bear the inspection legend or any abbreviation
or representation thereof unless manufactured under the food inspection
service provided for in part 350 of subchapter B of this chapter. When
such mixtures are manufactured in any part of an official establishment,
the sanitation of that part of the establishment shall be supervised by
Program employees, and the manufacture of such mixtures shall not cause
any deviation from the requirement of Sec. 318.1.
[35 FR 15586, Oct. 3, 1970, as amended at 38 FR 29215, Oct. 23, 1973]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR318.14]
[Page 249-250]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.14 Adulteration of product by polluted water; procedure for handling.
(a) In the event there is polluted water (including but not limited
to flood water) in an official establishment, all products and
ingredients for use in the preparation of such products that have been
rendered adulterated by the water shall be condemned.
(b) After the polluted water has receded from an official
establishment, all walls, ceilings, posts, and floors of the rooms and
compartments involved, including the equipment therein, shall, under the
supervision of an inspector, be cleaned thoroughly by the official
establishment personnel. An adequate supply of hot water under pressure
is essential to make such cleaning effective. After cleaning, a solution
of sodium hypochlorite containing approximately one-half of 1 percent
available chlorine (5,000 p/m) or other equivalent disinfectant approved
by the Administrator \1\ shall be applied to the surface of the rooms
and equipment and rinsed with potable water before use.
(c) Hermetically sealed containers of product which have been
contaminated by polluted water shall be examined promptly by the
official establishment under supervision of an inspector and rehandled
as follows:
(1) Separate and condemn all product in damaged or extensively
rusted containers.
(2) Remove paper labels and wash the remaining containers in warm
soapy water, using a brush where necessary to remove rust or other
foreign material. Disinfect these containers by either of the following
methods:
(i) Immerse in a solution of sodium hypochlorite containing not less
than 100 p/m of available chlorine or other equivalent disinfectant
approved by
[[Page 250]]
the Administrator, \1\ rinse in potable water, and dry thoroughly; or
---------------------------------------------------------------------------
\1\ A list of approved disinfectants is available upon request to
Scientific Services, Meat and Poultry Inspection Program, Food Safety
and Inspection Service, U.S. Department of Agriculture, Washington, DC
20250.
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(ii) Immerse in 212 deg.F. water, bring temperature of the water
back to 212 deg.F. and maintain the temperature at 212 deg.F. for 5
minutes, then remove containers from water and cool them to 95 deg.F.
and dry thoroughly.
(3) After handling as described in paragraph (c)(2) of this section,
the containers may be relacquered, if necessary, and then relabeled with
approved labels applicable to the product therein.
(4) The identity of the canned product shall be maintained
throughout all stages of the rehandling operations to insure correct
labeling of the containers.
[35 FR 15586, Oct. 3, 1970, as amended at 38 FR 34455, Dec. 14, 1973]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR318.15]
[Page 250]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.15 Tagging chemicals, preservatives, cereals, spices, etc., "U.S. retained."
When any chemical, preservative, cereal, spice, or other substance
is intended for use in an official establishment, it shall be examined
by a Program employee and if found to be unfit or otherwise unacceptable
for the use intended, or if final decision regarding acceptance is
deferred pending laboratory or other examination, the employee shall
attach a "U.S. retained" tag to the substance or container thereof.
The substance so tagged shall be kept separate from other substances as
the circuit supervisor may require and shall not be used until the tag
is removed, and such removal shall be made only by a Program employee
after a finding that the substance can be accepted, or, in the case of
an unacceptable substance, when it is removed from the establishment.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR318.16]
[Page 250]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.16 Pesticide chemicals and other residues in products.
(a) Nonmeat ingredients. Residues of pesticide chemicals, food
additives and color additives or other substances in or on ingredients
(other than meat, meat byproducts, and meat food products) used in the
formulation of products shall not exceed the levels permitted under the
Federal Food, Drug, and Cosmetic Act, and such nonmeat ingredients must
otherwise be in compliance with the requirements under that Act.
(b) Products, and meat, meat byproduct, or other meat food product
ingredients. Products, and products used as ingredients of products,
shall not bear or contain any pesticide chemical, food additives, or
color additive residue in excess of the level permitted under the
Federal Food, Drug, and Cosmetic Act and the regulations in this
subchapter, or any other substance that is prohibited by such
regulations or that otherwise makes the products adulterated.
(c) Standards and procedures. Instructions specifying the standards
and procedures for determining when ingredients of finished products are
in compliance with this section shall be issued to the inspectors by the
Administrator. Copies of such instructions will be made available to
interested persons upon request made to the Administrator.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR318.17]
[Page 250-251]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.17 Requirements for the production of cooked beef, roast beef, and cooked corned beef products.
(a) Cooked beef, roast beef, and cooked corned beef products must be
produced using processes ensuring that the products meet the following
performance standards:
(1) Lethality. A 6.5-log10 reduction of Salmonella or an
alternative lethality that achieves an equivalent probability that no
viable Salmonella organisms remain in the finished product, as well as
the reduction of other pathogens and their toxins or toxic metabolites
necessary to prevent adulteration, must be demonstrated to be achieved
throughout the product. The lethality process must include a cooking
step. Controlled intermediate step(s) applied to raw product may form
part of the basis for the equivalency.
(2) Stabilization. There can be no multiplication of toxigenic
microorganisms such as Clostridium botulinum, and no more than 1-
log10 multiplication of Clostridium perfringens within the
product.
[[Page 251]]
(b) For each product produced using a process other than one
conducted in accordance with the Hazard Analysis and Critical Control
Point (HACCP) system requirements in part 417 of this chapter, an
establishment must develop and have on file and available to FSIS, a
process schedule, as defined in Sec. 301.2 of this chapter. Each process
schedule must be approved in writing by a process authority for safety
and efficacy in meeting the performance standards established for the
product in question. A process authority must have access to the
establishment in order to evaluate and approve the safety and efficacy
of each process schedule.
(c) Under the auspices of a processing authority, an establishment
must validate new or altered process schedules by scientifically
supportable means, such as information gleaned from the literature or by
challenge studies conducted outside the plant.
[64 FR 744, Jan. 6, 1999]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR318.18]
[Page 251]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.18 Handling of certain material for mechanical processing.
Material to be processed into "Mechanically Separated (Species)"
shall be so processed within 1 hour from the time it is cut or separated
from carcasses or parts of carcasses, except that such product may be
held for no more than 72 hours at 40 deg.F. (4 deg.C.) or less, or
held indefinitely at 0 deg.F. (-18 deg.C.) or less. "Mechanically
Separated (Species)" shall, directly after being processed, be used as
an ingredient in a meat food product except that it may be held prior to
such use for no more than 72 hours at 40 deg.F. (4 deg.C.) or less or
indefinitely at 0 deg.F. (-18 deg.C.) or less.
[43 FR 26423, June 20, 1978, as amended at 47 FR 28256, June 29, 1982]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR318.19]
[Page 251-255]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
Subpart A--General
Sec. 318.19 Compliance procedure for cured pork products.
(a) Definitions. For the purposes of this section:
(1) A product is that cured pork article which is contained within
one Group as defined in paragraph (a)(2) of this section and which
purports to meet the criteria for a single product designated under the
heading "Product Name and Qualifying Statements" in the chart in
Sec. 319.104 or the chart in Sec. 319.105.
(2) A Product Group or a Group means one of the following:
Group I, consisting of cured pork products which have been cooked
while imperviously encased. Any product which fits into the Group will
be placed in this Group regardless of any other considerations.
Group II, consisting of cured pork products which have been water
cooked. Any product which does not fit into Group I but does fit into
Group II will be placed into Group II regardless of any other
considerations.
Group III, consisting of boneless smokehouse heated cured pork
products. Any boneless product that does not fit into Group I or Group
II shall be placed in Group III.
Group IV, consisting of bone-in or semi-boneless smokehouse heated
cured pork products. Any product that is not completely boneless or
still contains all the bone which is traditional for bone-in product,
and does not fit into Group I, Group II, or Group III shall be placed in
this Group.
(3) A lot is that product from one production shift.
(4) A production rate is frequency of production, expressed in days
per week.
(5) Protein fat free percentage, protein fat free content, PFF
percentage, PFF content or PFF of a product means the meat protein
(indigenous to the raw, unprocessed pork cut) content expressed as a
percent of the non-fat portion of the finished product.
(b) Normal Compliance Procedures. The Department shall collect
samples of cured pork products and analyze them for their PFF content.
Analyses shall be conducted in accordance with the "Official Methods of
Analysis of the Association of Official Analytical Chemists
Secs. 950.46, and 928.08 (Chapter 39).\1\ The "Official Methods of
Analysis of the Association of Official Analytical Chemists," 15th
edition, 1990, is incorporated by reference with the approval of the
Director of the Federal Register in accordance with 5 U.S.C.
[[Page 252]]
552(a) and 1 CFR part 51. Each analytical result shall be recorded and
evaluated to determine whether future sampling of product Groups within
an official establishment shall be periodic or daily under the
provisions of paragraph (b)(1) of this section, and if the affected lot
and subsequent production of like product shall be U.S. retained, or
administratively detained, as appropriate, as provided in paragraph
(b)(2) of this section.\2\
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\1\ A copy of the "Official Methods of Analysis of the Association
of Official Analytical Chemists," 15th edition, 1990, is on file with
the Director, Office of the Federal Register, and may be purchased from
the Association of Official Analytical Chemists, Inc., 2200 Wilson
Boulevard, Suite 400, Arlington, Virginia 22201.
\2\ Rules for Rounding:
1. Laboratory results for percent meat protein and fat will be
reported to the second decimal place (hundredths).
2. PFF and Sample Values for charting purposes will be calculated
from the reported laboratory results to the second decimal place.
Rounding of calculations to reach two decimal places will be done by the
following rule:
All values of five-thousandths (0.005) or more will be rounded up to
the next highest hundredth. All values of less than five-thousandths
(0.005) will be dropped.
3. For compliance with the Absolute Minimum PFF requirements, the
PFF will be rounded to the first decimal place (tenths). Rounding of
calculations to reach one decimal place will be done by the following
rule:
All PFF values of five-hundredths (0.05) or more will be rounded up
to the next highest tenth. All PFF values of less than five-hundredths
(0.05) will be dropped.
4. For product disposition (pass-fail of a minimum PFF standard for
retained product) the average PFF calculation will be rounded to the
first decimal place. Individual PFF Values will be calculated to the
nearest hundredth as in (2) above. The average, however, will be rounded
to the nearest tenth as in (3) above.
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(1) Criteria to determine sampling frequency of Product Groups. For
each official plant preparing cured pork products, Product Groups shall
be sampled periodically or daily. Analytical results shall be evaluated
and the sampling frequency determined as follows:
(i) Determine the difference between the individual PFF analysis and
the applicable minimum PFF percentage requirement of Sec. 319.104 or
Sec. 319.105. The resulting figure shall be negative when the individual
sample result is less than the applicable minimum PFF percentage
requirement and shall be positive when the individual sample result is
greater than the applicable minimum PFF percentage requirement.
(ii) Divide the resulting number by the standard deviation assigned
to the Product Group represented by the sample to find the Standardized
Difference. The standard deviation assigned to Groups I and II is 0.75
and to Groups III and IV is 0.91.
(iii) Add 0.25 to the Standardized Difference to find the Adjusted
Standardized Difference.
(iv) Use the lesser of 1.90 and the Adjusted Standardized Difference
as the Sample Value.
(v) Cumulatively total Sample Values to determine the Group Value.
The first Sample Value in a Group shall be the Group Value, and each
succeeding Group Value shall be determined by adding the most recent
Sample Value to the existing Group Value; provided, however, that in no
event shall the Group Value exceed 1.00. When calculation of a Group
Value results in a figure greater than 1.00, the Group Value shall be
1.00 and all previous Sample Values shall be ignored in determining
future Group Values.
(vi) The frequency of sampling of a Group shall be periodic when the
Group Value is greater than -1.40 (e.g., -1.39, -1.14, 0, 0.50, etc.)
and shall be daily when the Group Value is -1.40 or less (e.g., -1.40, -
1.45, -1.50, etc.); provided, however, that once daily sampling has been
initiated, it shall continue until the Group Value is 0.00 or greater,
and each of the last seven Sample Values is -1.65 or greater (e.g., -
1.63, -1.50, etc.), and there is no other product within the affected
Group being U.S. retained as produced, under provisions of paragraph
(b)(2) or (c).
(2) Criteria for U.S. retention or administrative detention of cured
pork products for further analysis. Cured prok products shall be U.S.
retained, or administratively detained, as appropriate, when prescribed
by paragraphs (b)(2) (i) or (ii) of this section as follows:
(i) Absolute Minimum PFF Requirement. In the event that an analysis
of an individual sample indicates a PFF content below the applicable
minimum requirement of Sec. 319.104 or Sec. 319.105 by 2.3 or more
percentage points for a Group I or II product, or 2.7 or more percentage
points for a Group III or IV product, the lot from which the sample
[[Page 253]]
was collected shall be U.S. retained if in an official establishment and
shall be subject to administrative detention if not in an official
establishment unless returned to an official establishment and there
U.S. retained. Any subsequently produced lots of like product and any
lots of like product for which production dates cannot be established
shall be U.S. retained or subject to administrative detention. Such
administratively detained product shall be handled in accordance with
part 329 of this subchapter, or shall be returned to an official
establishment and subjected to the provisions of paragraph (c)(1) (i) or
(ii) of this section, or shall be relabeled in compliance with the
applicable standard, under the supervision of a program employee, at the
expense of the product owner. Disposition of such U.S. retained product
shall be in accordance with paragraph (c) of this section.
(ii) Product Value requirement. The Department shall maintain, for
each product prepared in an official establishment, a Product Value.
Except as provided in paragraph (c)(2) of this section, calculation of
the Product Value and its use to determine if a product shall be U.S.
retained shall be as follows:
(A) Determine the difference between the individual PFF analysis and
applicable minimum PFF percentage requirement of Sec. 319.104 and
Sec. 319.105. The resulting figure shall be negative when the individual
sample result is less than the applicable minimum PFF percentage
requirement and shall be positive when the individual sample result is
greater than the applicable minimum PFF percentage requirement.
(B) Divide the difference determined in paragraph (b)(2)(ii)(A) of
this section by the standard deviation assigned to the product's Group
in paragraph (b)(1)(ii) of this section to find the standardized
difference.
(C) Use the lesser of 1.65 and the standardized difference as the
Sample Value.
(D) Cumulatively total Sample Values to determine the Product Value.
The first Sample Value of a product shall be the Product Value, and each
succeeding Product Value shall be determined by adding the most recent
Sample Value to the existing Product Value; provided, however, that in
no event shall the Product Value exceed 1.15. When calculation of a
Product Value results in a figure greater than 1.15, the Product Value
shall be 1.15, and all previous Sample Values shall be ignored in
determining future Product Values.
(E) Provided daily group sampling is in effect pursuant to the
provisions of paragraph (b)(1) of this section, and provided further the
Product Value is -1.65 or less (e.g., -1.66), the affected lot (if
within the official establishment) and all subsequent lots of like
product prepared by and still within the official establishment shall be
U.S. retained and further evaluated under paragraph (c) of this section.
Except for release of individual lot pursuant to paragraph (c)(1),
subsequently produced lots of like product shall continue to be U.S.
retained until discontinued pursuant to paragraph (c)(2) of this
section.
(c) Compliance procedure during product retention. When a product
lot is U.S. retained under the provisions of paragraph (b)(2) of this
section, the Department shall collect three randomly selected samples
from each such lot and analyze them individually for PFF content. The
PFF content of the three samples shall be evaluated to determine
disposition of the lot as provided in paragraph (c)(1) of this section
and the action t