[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR318.309]
[Page 303-304]
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 G_Canning and Canned Products
Sec. 318.309 Finished product inspection.
(a) Finished product inspections must be handled according to:
(1) A HACCP plan for canned product that addresses hazards
associated with microbiological contamination;
(2) An FSIS-approved total quality control system;
(3) Alternative documented procedures that will ensure that only
safe and stable product is shipped in commerce; or
(4) Paragraph (d) of this section.
(b)-(c) [Reserved]
(d) Procedures for handling finished product inspections where the
HACCP plan for thermally processed/commercially sterile product does not
address food safety hazards associated with microbial contamination,
where there is no approved total quality control system, or where the
establishment has no alternative documented procedures for handling
process deviations.
(1) Incubation of shelf stable canned product--(i) Incubator. The
establishment shall provide incubation facilities which include an
accurate temperature/time recording device, an indicating temperature
device, a means for the circulation of the air inside the incubator to
prevent temperature variations, and a means to prevent unauthorized
entry into the facility. The Program is responsible for the security of
the incubator.
(ii) Incubation temperature. The incubation temperature shall be
maintained at 955 [deg]F (352.8 [deg]C). If the incubation temperature falls below
90 [deg]F (or 32 [deg]C) or exceeds 100 [deg]F (or 38 [deg]C) but does
not reach 103 [deg]F (or 39.5 [deg]C), the incubation temperature shall
be adjusted within the required range and the incubation time extended
for the time the sample containers were held at the deviant temperature.
If the incubation temperature is at or above 103 [deg]F (or 39.5 [deg]C)
for more than 2 hours, the incubation test(s) shall be terminated, the
temperature lowered to within the required range, and new sample
containers incubated for the required time.
(iii) Product requiring incubation. Shelf stable product requiring
incubation includes:
(a) Low acid products as defined in Sec. 318.300(m); and
(b) Acidified low acid products as defined in Sec. 318.300(b).
(iv) Incubation samples. (a) From each load of product processed in
a batch-type thermal processing system (still or agitation), the
establishment shall select at least one container for incubation.
(b) For continuous rotary retorts, hydrostatic retorts, or other
continuous-type thermal processing systems, the establishment shall
select at least one container per 1,000 for incubation.
(c) Only normal-appearing containers shall be selected for
incubation.
(v) Incubation time. Canned product requiring incubation shall be
incubated for not less than 10 days (240 hours) under the conditions
specified in paragraph (d)(1)(ii) of this section.
(vi) Incubation checks and record maintenance. Designated
establishment employees shall visually check all containers under
incubation each working day and the inspector shall be notified when
abnormal containers are detected. All abnormal containers should be
allowed to cool before a final decision on their condition is made. For
each incubation test the establishment shall record at least the product
name, container size, container code, number of containers incubated, in
and out dates, and incubation results. The establishment shall retain
such records, along with copies of the temperature/time recording
charts, in accordance with Sec. 318.307(e).
(vii) Abnormal containers. The finding of abnormal containers (as
defined in Sec. 318.300(a)) among incubation samples is cause to
officially retain at least the code lot involved.
(viii) Shipping. No product shall be shipped from the establishment
before the end of the required incubation period except as provided in
this paragraph or paragraph (b) or (c) of this section. An establishment
wishing to ship product prior to the completion of
[[Page 304]]
the required incubation period shall submit a written proposal to the
area supervisor. Such a proposal shall include provisions that will
assure that shipped product will not reach the retail level of
distribution before sample incubation is completed and that product can
be returned promptly to the establishment should such action be deemed
necessary by the incubation test results. Upon receipt of written
approval from the area supervisor, product may be routinely shipped
provided the establishment continues to comply with all requirements of
this subpart.
(2) Container condition--(i) Normal containers. Only normal-
appearing containers shall be shipped from an establishment as
determined by an appropriate sampling plan or other means acceptable to
Program employees.
(ii) Abnormal containers. When abnormal containers are detected by
any means other than incubation, the establishment shall inform the
inspector, and the affected code lot(s) shall not be shipped until the
Program has determined that the product is safe and stable. Such a
determination will take into account the cause and level of abnormals in
the affected lot(s) as well as any product disposition actions either
taken or proposed by the establishment.
(Approved by the Office of Management and Budget under control number
0583-0015)
[51 FR 45619, Dec. 19, 1986, as amended at 57 FR 37872, Aug. 21, 1992;
57 FR 55443, Nov. 25, 1992; 62 FR 45025, Aug. 25, 1997; 65 FR 34389, May
30, 2000; 65 FR 53532, Sept. 5, 2000]