[Federal Register Volume 83, Number 105 (Thursday, May 31, 2018)]
[Rules and Regulations]
[Pages 25302-25325]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11300]



[[Page 25301]]

Vol. 83

Thursday,

No. 105

May 31, 2018

Part IV





Department of Agriculture





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Food Safety and Inspection Service





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9 CFR Parts 301, 303, 318, et al.





Elimination of Trichinae Control Regulations and Consolidation of 
Thermally Processed, Commercially Sterile Regulations; Rule

  Federal Register / Vol. 83 , No. 105 / Thursday, May 31, 2018 / Rules 
and Regulations  

[[Page 25302]]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 301, 303, 318, 319, 320, 325, 331, 381, 417, 424, 431, 
and 548

[Docket No. FSIS-2015-0036]
RIN 0583-AD59


Elimination of Trichinae Control Regulations and Consolidation of 
Thermally Processed, Commercially Sterile Regulations

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the 
Federal meat inspection regulations to eliminate the requirements for 
both ready-to-eat (RTE) and not-ready-to-eat (NRTE) pork and pork 
products to be treated to destroy trichinae (Trichinella spiralis) 
because the regulations are inconsistent with the Hazard Analysis and 
Critical Control Point (HACCP) regulations, and because these 
prescriptive regulations are no longer necessary. FSIS is ending its 
Trichinella Approved Laboratory Program (TALP program) for the 
evaluation and approval of non-Federal laboratories that use the pooled 
sample digestion technique to analyze samples for the presence of 
trichinae. FSIS is also consolidating the regulations on thermally 
processed, commercially sterile meat and poultry products (i.e., canned 
food products containing meat or poultry).

DATES: Effective date: July 30, 2018.

FOR FURTHER INFORMATION CONTACT: Roberta Wagner, Assistant 
Administrator, Office of Policy and Program Development; Telephone: 
(202) 205-0495.

SUPPLEMENTARY INFORMATION: 

Background

    On February 27, 2001, FSIS proposed food safety performance 
standards for all RTE and all partially heat-treated meat and poultry 
products (66 FR 12590). The proposed performance standards included 
both levels of pathogen reduction and limits on pathogen growth that 
official meat and poultry establishments would be required to meet in 
the production of these products.
    The Agency also proposed to rescind the requirements in the meat 
inspection regulations that prescribe treatments of pork and pork 
products to eliminate trichinae because the requirements are 
inconsistent with the HACCP regulations (9 CFR part 417).
    The Agency further proposed to require that all thermally 
processed, commercially sterile meat and poultry products be processed 
to either eliminate or control the growth of Clostridium botulinum, 
depending on the pH of the product or other factors affecting the 
growth of that pathogen. The processing of a low-acid canned product 
that receives thermal or other sporicidal lethality processing would 
have had to meet a 12-log10 reduction standard for C. 
botulinum. The processing of acidified low-acid products and of some 
cured products and other canned products in which pathogen growth is 
controlled by factors other than the thermal process would have had to 
prevent growth rather than achieve any specific decimal reduction of C. 
botulinum. All thermally processed, commercially sterile products would 
have had to be commercially sterile and their containers hermetically 
sealed.
    Finally, the Agency proposed that each establishment that produces 
RTE meat and poultry products would have to test food contact surfaces 
for Listeria species to verify the efficacy of its sanitation standard 
operating procedures unless it had incorporated one or more controls 
for Listeria monocytogenes (Lm) into its HACCP plan. FSIS addressed Lm 
separately in the interim final rule ``Control of Listeria 
monocytogenes in RTE Meat and Poultry Products,'' published June 6, 
2003 (68 FR 34208), and affirmed the interim final rule with minor 
changes on June, 19, 2015 (80 FR 35178).
    Because of the length of time since the publication of the proposed 
rule, FSIS published a supplemental proposed rule on March 28, 2016, to 
provide the public an additional opportunity to comment (81 FR 17337). 
In the supplemental proposed rule, FSIS only addressed the proposed 
changes to the regulations on control of trichinae in pork products and 
on thermally processed, commercially sterile meat and poultry products. 
FSIS withdrew the other provisions of the 2001 proposed rule because 
the Agency's current regulations and inspection program have been 
effective at preventing adulterated RTE product from entering commerce 
(81 FR 17337, 17338).
    FSIS re-proposed the changes to remove the trichinae requirements, 
consistent with what FSIS originally proposed in 2001. FSIS explained 
that if the supplemental proposed rule was finalized, FSIS would end 
its Trichinella Approved Laboratory Program (TALP) for the evaluation 
and approval of non-Federal laboratories that use the pooled sample 
digestion technique to analyze samples for the presence of trichinae. 
In addition, rather than what it proposed in 2001, FSIS proposed to 
combine the meat and poultry canning regulations into a new part in the 
regulations and to make minor changes that improve the clarity of the 
regulations and remove redundant sections. After reviewing the comments 
on the supplemental proposed rule, FSIS is finalizing it with one small 
change. Specifically, the Agency is updating the cross-reference in 9 
CFR 548.6 to the new thermally processed, commercially sterile 
regulations.

Compliance Guidance

    FSIS also is announcing the availability of a compliance guide to 
help establishments, particularly small and very small establishments, 
in understanding the controls that are effective for the prevention and 
elimination of trichinae in RTE and NRTE pork products. When FSIS 
published the supplemental proposed rule, FSIS posted a draft of the 
trichinae compliance guide on its website and requested comments on the 
guide. FSIS has revised the trichinae compliance guide based on 
comments on the supplemental proposed rule and draft compliance guide 
to clarify that FSIS is not requiring establishments to use validated 
cooking instructions. The changes to the trichinae compliance guide are 
discussed in more detail below. FSIS has posted the compliance guide on 
its web page (http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index).

Comments and Responses

    FSIS received 11 comments from trade associations representing meat 
processors, official establishments, an organization supporting 
sustainable farming, a food safety consulting firm, a trade association 
representing shelf-stable food processors, and individuals. All but one 
of these comments supported the proposal to eliminate the prescriptive 
trichinae control regulations. One individual opposed the proposal 
because, according to the commenter, the trichinae control regulations 
are effective. Only comments from a trade association representing meat 
processors and a trade association representing shelf-stable food 
processors addressed the proposed changes to the thermally processed, 
commercially sterile regulations. Both comments supported

[[Page 25303]]

the proposal to consolidate the thermally processed, commercially 
sterile regulations. After review and consideration of all of the 
comments, as is stated above, FSIS will eliminate the trichinae control 
regulations and finalize the proposed thermally processed commercially 
sterile regulations. A summary of comments follows.

Elimination of the Trichinae Control Regulations

    Comment: One individual consumer suggested that FSIS keep the 
trichinae control regulations because, according to the commenter, the 
fact that the rate of Trichinella and trichinellosis in the U.S. is 
currently at an all-time low shows that the regulations are working. 
The same commenter argued that eliminating the trichinae control 
regulations would reduce national food safety standards because, 
according to the commenter, establishments will not always follow their 
HACCP plans, and establishments may not adequately eliminate trichinae 
from pork products produced in the U.S. with pork from foreign 
countries where trichinae is a greater risk.
    Response: FSIS finds no merit in the commenter's argument that 
eliminating the trichinae control regulations will reduce food safety 
because the HACCP regulations will not be effective in preventing 
adulterated pork products from entering the human food supply. As FSIS 
explained in the proposed rule, many establishments producing pork 
products already address trichinae in their HACCP plans or in a pre-
requisite program (81 FR 17337, 17339). Under this final rule, all 
establishments producing pork products from swine slaughtered in the 
U.S. or eligible foreign countries will have to determine whether 
trichinae is a hazard reasonably likely to occur (RLTO) in their 
processes. If it is, they must address this hazard in their HACCP plans 
or in a pre-requisite program. FSIS inspectors will verify that 
establishments are following their HACCP plans and pre-requisite 
programs and that their HACCP plans and pre-requisite programs are 
effective at preventing or controlling for trichinae. If FSIS 
inspectors determine that establishments have inadequate HACCP systems, 
FSIS will take a withholding action or impose a suspension (see 9 CFR 
500.4(a)).
    Comment: A few commenters from trade associations representing meat 
processors were concerned that the proposed rule required validated 
cooking instructions for controlling trichinae in raw, not-ready-to-eat 
(NRTE) products. The commenters argued that requiring small and very 
small establishments that produce raw, NRTE pork products to include 
validated cooking instructions on their labels would cause an undue 
burden. One commenter from an organization supporting sustainable 
farming recommended that FSIS conduct education and outreach activities 
to ensure that both industry and FSIS inspectors understand the new 
requirements.
    Response: FSIS is removing 9 CFR 318.10(a)(1) and clarifying in 
this final rule and in the compliance guide that this change should not 
affect the way that establishments currently label their products. FSIS 
is not creating a new requirement for establishments to use validated 
cooking instructions on their labels of raw, NRTE pork products. 
However, if establishments voluntarily choose to use cooking 
instructions on their labels, then the cooking instructions must be 
validated.
    In addition to providing the guidance on trichinae discussed above, 
the Agency will host webinars for industry to explain how 
establishments can address trichinae in their HACCP systems. FSIS will 
also update instructions to our inspection program personnel to ensure 
that they are all aware that the Agency is removing the trichinae 
control regulations and that all establishments producing pork products 
will have to address trichinae under the HACCP regulations (9 CFR part 
417).
    Comment: Two commenters from trade associations representing meat 
processors requested that FSIS delay publishing a final rule until the 
industry, in cooperation with USDA, establish a negligible risk 
compartment \1\ in accordance with the new international standards for 
trichinae control. The same commenters were concerned that eliminating 
the trichinae control regulations before establishing a negligible risk 
compartment could have a negative impact on the international trade of 
U.S. pork products because current trade agreements reference the 
specific time and temperature combinations for commercial cooking and 
freezing of pork found in 9 CFR 318.10. One of those commenters argued 
that facility-specific HACCP-based control measures would be difficult 
to validate and may not satisfy foreign trading partners. The same 
commenter suggested that the methods in 9 CFR 318.10 should be 
preserved as references for effective mitigations of Trichinella while 
they are still referenced in trade agreements. One of these commenters 
noted that FSIS would conserve Agency and industry resources by 
delaying publishing a final rule until the negligible risk compartment 
is established, thereby requiring only one round of revision to both 
the Export Library and establishments' HACCP plans.
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    \1\ A negligible risk compartment for trichinae would require 
controlled management conditions for swine herds; at least 24 months 
of data demonstrating the absence of Trichinella infection in the 
herds; ongoing verification of the status of the compartment; and a 
response plan for deviations from negligible risk (World 
Organisation for Animal Health. (2016). Terrestrial Animal Health 
Code. Retrieved from http://www.oie.int/international-standard-setting/terrestrial-code/access-online/).
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    Response: The Agency does not see a reason to delay issuing this 
final rule because many establishments producing pork products already 
address trichinae in a pre-requisite program or in their HACCP plans 
(81 FR 17337, 17339). The negligible risk compartment was included in 
the supplemental proposed rule and the draft compliance guidance as an 
example of an on-farm pre-requisite program that could be used in the 
future to support decisions in a hazard analysis that trichinae is not 
reasonably likely to occur (NRLTO) because live swine were raised under 
strict biosecurity standards and, therefore, were not exposed to 
rodents and wildlife infected with Trichinella. FSIS will not require 
participation in the negligible risk compartment. Establishments may 
use any Animal and Plant Health Inspection Service (APHIS) approved 
validated Trichinella pre-harvest safety program that complies with the 
World Organization for Animal Health's (OIE's) guidance for 
Trichinella.
    FSIS considers the time and temperature combinations for commercial 
cooking and freezing of pork in 9 CFR 318.10 as safe harbors that have 
been scientifically validated and has incorporated these requirements 
into the trichinae compliance guidance discussed above. Establishments 
may continue to produce their products using these ``safe harbors,'' or 
they may choose to develop their own validated cooking or freezing 
procedures that will effectively eliminate trichinae. FSIS will update 
the Export Library to add the specific time and temperature 
combinations for commercial cooking and freezing of pork that were 
found in 9 CFR 318.10 for countries that require these times and 
temperatures. This update will ensure that establishments are aware of 
export requirements and prevent trade interruptions.
    FSIS does not agree that removing the trichinae control regulations 
will waste Agency or industry resources because FSIS routinely updates 
the Export Library, and establishments must

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conduct annual reassessments of their HACCP plans. Because 
participation in the negligible risk compartment will not be mandatory, 
establishments may or may not decide to revise their HACCP plans if 
APHIS establishes the risk compartment. Establishments will have the 
flexibility to determine how they will control for trichinae in their 
products.
    Comment: One commenter from an association representing meat 
processors stated that the U.S. does not have a program that allows 
pigs to be classified as having a negligible risk for Trichinella 
because, according to the commenter, APHIS no longer has the U.S. 
Trichinae Certification Program. The same commenter argued that packers 
will have no tools, other than individual carcass testing, to determine 
the risk status of Trichinella in pigs and therefore, it is not 
possible to make fully informed decisions on risk in a HACCP plan 
addressing Trichinella. Commenters from an association supporting 
sustainable agriculture and a food-safety consulting firm requested 
that FSIS add the industry Pork Quality Assurance (PQA) Plus program to 
the Compliance Guide as an acceptable pre-requisite program for 
controlling trichinae. The commenter stated that the PQA Plus program 
is based on HACCP principles and was developed by the National Pork 
Board to identify on-farm practices with potential to result in food 
safety hazards and to minimize these potential risks by improving on-
farm biosecurity practices through producer education.
    One commenter from an official establishment stated that FSIS 
should revise the draft compliance guide because, according to the 
commenter, industry has eliminated exposure of animals to garbage and 
rodents and, therefore, science does not support that pigs raised in 
pasture operations are at a higher risk for trichinae than others. The 
same commenter stated that the claims that pasture operations create a 
higher risk for trichinae will significantly limit establishments' 
market opportunities.
    Response: FSIS disagrees with the comment that it is not possible 
to make fully informed decisions on the risks of Trichinella in HACCP 
plans because packers have limited resources to assess the risk status 
of Trichinella in pigs. As FSIS explained in the supplemental proposed 
rule, many establishments producing pork products already address 
trichinae in their HACCP plans or in a pre-requisite program (81 FR 
17337, 17339). In addition, the compliance guide explains several 
different ways that establishments can control or eliminate trichinae. 
APHIS's U.S. Trichinae Certification Program is just one option that is 
currently available to packers and establishments for the control for 
trichinae.
    FSIS has decided that the PQA Plus program is an acceptable pre-
requisite program for fresh pork products that were previously covered 
under 9 CFR 318.10(a). However, the PQA Plus program alone is not 
sufficient for products that were covered under 9 CFR 318.10(b) because 
these products pose a greater risk for Trichinella infection to 
consumers. Additionally, establishments that export to foreign 
countries should be aware that not all countries will accept the PQA 
Plus program as an acceptable pre-requisite program because it does not 
meet OIE standards. Therefore, for products previously covered under 9 
CFR 318.10(a), establishments should use PQA Plus and treat pork 
products for the destruction of Trichinella.
    The compliance guide states, ``the risk of infection with 
Trichinella is increased in pasture raised swine that have access to 
rodents and wildlife infected with Trichinella.'' However, FSIS 
recognizes that not all pasture-raised swine are exposed to potentially 
infected reservoir hosts. Under the HACCP regulations, establishments 
producing RTE or NRTE pork products must address trichinae in their 
HACCP system if Trichinella and other parasites are hazards reasonably 
likely to occur in their processes. Establishments may determine that 
the parasitic hazard is not reasonably likely to occur because a pre-
requisite program prevents the hazard, but they must have documentation 
to support the decisions in their hazard analysis (9 CFR 417.5(a)(1)). 
FSIS disagrees that the statement in the compliance guide that the risk 
of infection with Trichinella is increased in pasture raised swine that 
have access to rodents and wildlife infected with Trichinella will 
affect establishments' market opportunities.
    Comment: Two trade associations representing meat processors argued 
that, given the lack of tools for assessing risk for Toxoplasma gondii 
(T. gondii), a protozoan parasite that can cause the disease 
toxoplasmosis, in pork, and the lack of international or national 
standards for this parasite, including mention of T. gondii in the 
compliance guide in relation to HACCP plans is premature. Furthermore, 
according to the commenters, there are no tests that can be performed 
at the establishment to determine whether live pigs are infected with 
T. gondii. The commenters argued that including T. gondii in the 
compliance guide could have a negative impact on trade for U.S. pork 
producers. The commenters stated that current consumer guidelines for 
preparation of NRTE pork are effective for inactivation of T. gondii.
    Response: Producers of RTE and NRTE pork products must assess in 
their hazard analysis which potential hazards are reasonably likely to 
occur (RLTO) in their production processes (9 CFR 417.2), and parasites 
could be a potential hazard. If establishments determine that parasites 
are a hazard that is RLTO, then they must include control procedures 
for these parasites in their HACCP plans. Establishments may determine 
that parasites are NRLTO, but they must have documentation to support 
the decisions in their hazard analysis (9 CFR 417.5(a)(1)). FSIS is 
keeping the section on T. gondii in the compliance guide to raise 
awareness of the parasite and provide valuable scientific information 
to assist establishments in conducting a hazard analysis. However, it 
should be noted that the compliance guidance represents best practice 
recommendations by FSIS, based on the best available scientific and 
practical consideration, and does not represent requirements that must 
be met. Establishments may choose to adopt different procedures than 
those outlined in the compliance guidance.
    FSIS disagrees with the comments that it is not possible to make 
fully informed decisions on the risks of T. gondii in HACCP plans 
because packers have limited resources to assess the risk status of T. 
gondii in live pigs and carcasses. As explained in the compliance 
guide, the risk of infection with T. gondii is significantly increased 
in pasture-raised swine that are exposed to environmental contamination 
with cat feces in soil, grass, feed, or water. The compliance guide 
explains that while there are no programs to certify the risk of T. 
gondii in live swine, packers can prevent toxoplasma infection in swine 
through incorporating good production practices. Additionally, the 
compliance guide explains that while there are no direct testing 
methods for T. gondii that can be performed at slaughter, 
establishments can eliminate the parasitic hazard through the same 
heating, freezing, high-pressure processing, and irradiation methods 
that are used to eliminate Trichinella. FSIS has no reason to believe 
that including more information on T. gondii in the compliance guide 
will affect establishments' market opportunities.
    Finally, FSIS agrees with commenters that current consumer 
guidelines for preparation of NRTE pork are effective for inactivation 
of T. gondii. However,

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under HACCP regulations, establishments are required to address hazards 
RLTO in their products before the products reach the consumer.
    Comment: Two trade associations representing meat processors did 
not support ending the TALP program because, according to the 
commenters, ending the TALP program eliminates a tool that packers can 
use for assessing the absence of risk for Trichinella by testing. The 
commenters asked what oversight FSIS would provide of third-party 
testing. Another commenter from a food safety consulting firm 
recommended that FSIS revise the establishment testing protocols for 
trichinae to specifically include molecular testing as having the 
potential to be equivalent to current digestion testing methods.
    Response: FSIS is ending the TALP program to make more efficient 
use of its resources. As FSIS explained in the proposed rule, there is 
only one laboratory enrolled in the TALP program (81 FR 17338, 17340). 
Establishments may test product samples for the presence of trichinae 
using any validated testing method that is equivalent to the pooled 
sample digestion technique to verify that their system is working. FSIS 
has provided some guidance on sampling in the trichinae compliance 
guide. For example, establishments may enroll in the Agricultural 
Marketing Service's Trichinae Export Program, which tests for trichinae 
using the artificial digestion technique. Consistent with other 
industry testing, FSIS will not provide oversight of third-party 
testing and will not provide protocols for industry testing.
    Comment: One trade association representing meat processors stated 
that FSIS should review the costs associated with the elimination of 9 
CFR 318.10 and stated that the estimated costs were too low. The same 
commenter stated that FSIS did not provide a cost estimate for 
developing a HACCP plan that addresses trichinae and other hazards in 
pork products. The commenter also stated that FSIS did not consider the 
cost of participating in the U.S. Trichinae Certification Program. The 
commenter also requested that FSIS consider the costs of new validated 
cooking instruction labels.
    Response: After reviewing the costs associated with the elimination 
of 9 CFR 318.10, FSIS is affirming the cost estimates in the proposed 
rule. These estimates are in 2016 dollars. The numbers still reflect 
FSIS costs.
    FSIS disagrees with the comment that the Agency should provide a 
cost estimate for developing HACCP plans that address trichinae. As 
FSIS explained in the supplemental proposed rule, many establishments 
producing pork products already address trichinae in their HACCP plans 
or in a pre-requisite program (81 FR 17337, 17339). Also, the HACCP 
regulations have been in place since 1996 and since that time have 
required that establishments conduct hazard analyses and HACCP plans to 
address hazards that are RLTO, including trichinae. As explained above, 
FSIS considers the time and temperature combinations for commercial 
cooking and freezing of pork in 9 CFR 318.10 as safe harbors and has 
incorporated these requirements into the compliance guidance on 
controlling for trichinae. Because many establishments are already 
addressing trichinae under their current HACCP systems, and 
establishments are not required to change the way that they cook or 
freeze pork to control for trichinae, establishments will not incur 
costs related to developing HACCP plans. FSIS did not include the costs 
of participation in on-farm programs like the U.S. Trichinae 
Certification Program because participation in these programs is a 
business decision not required by FSIS. FSIS also did not consider the 
costs of new validated cooking instruction labels because the Agency is 
not requiring establishments to add validated cooking instructions on 
raw, NRTE pork products.

Thermally Processed, Commercially Sterile Regulations

    Two trade associations representing meat processors and a trade 
association representing shelf-stable food processors stated that the 
current regulations have been effective in ensuring safe and 
unadulterated products. Additionally, the commenters stated that 
finalizing the proposed changes to the thermally processed, 
commercially sterile regulations will improve clarity and 
understanding.
    Response: FSIS is finalizing the proposed changes to the thermally 
processed, commercially sterile regulations. The Agency also is 
updating the regulatory citations in 9 CFR 548.6, which cross-reference 
the thermally processed, commercially sterile regulations, from 9 CFR 
part 318, subpart G to 9 CFR part 431.

Executive Order 12866

    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Executive 
Order 13563 emphasizes the importance of quantifying both costs and 
benefits, of reducing costs, of harmonizing rules, and of promoting 
flexibility. This final rule has been designated as a ``non-
significant'' regulatory action under section 3(f) of Executive Order 
(E.O.) 12866. Accordingly, the final rule has not been reviewed by the 
Office of Management and Budget under E.O. 12866.

Economic Impact Analysis

    FSIS affirms the preliminary regulatory impact analysis \2\ and is 
finalizing this rule with only a small change to update the cross-
reference in 9 CFR 548.6 to the new thermally processed, commercially 
sterile regulations. As is discussed above, FSIS is removing the 
trichinae treatment requirements under 9 CFR 318.10 as this action will 
give industry the flexibility under HACCP to develop science-based food 
safety controls to address trichinae and other pork associated 
parasitic hazards. The removal of the requirements for trichinae 
treatment of pork products will not impose significant costs on the 
industry because the establishments can address trichinae in their 
existing HACCP plans. If an establishment has identified trichinae as a 
hazard RLTO, the establishment will have to ensure that the process it 
uses effectively eliminates the hazard under HACCP. Establishments will 
not need to change any steps in their production processes since the 
establishments can take the same measures that they are currently 
taking to address the presence of trichinae. However, establishments 
will have the flexibility to use alternative procedures to those 
previously prescribed in the regulations, as long as establishments 
address the hazard in their HACCP plans. Establishments will have the 
flexibility provided by the HACCP regulations to develop appropriate 
science-based controls for trichinae and other parasitic hazards in 
pork. Among the controls that can be employed are on-farm trichinae 
certification of hogs, lethality treatment for RTE product, and, for 
NRTE products, conspicuous labeling and validated cooking instructions.
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    \2\ http://www.fsis.usda.gov/wps/wcm/connect/2b8aef47-9718-423f-aafb-fa31573fdb7e/2015-0036.htm?MOD=AJPERES.
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    FSIS inspection program personnel will verify that establishments 
effectively address these hazards. Under the final rule, FSIS is ending 
the TALP

[[Page 25306]]

program, saving the Agency an average of $13,000 per year ($4,000 
annual material cost + $9,000 labor cost). TALP is a program under 
which FSIS has evaluated and approved non-Federal-laboratories that use 
the pooled-sample design technique to analyze samples for the presence 
of trichinae. There is only one laboratory enrolled in the TALP 
program. FSIS is eliminating this program because very few 
establishments are using the laboratory that is in the program. The 
program is no longer necessary, and eliminating it will allow the 
Agency to make more efficient use of its resources.
    The Agency also is combining the regulations for thermally 
processed, commercially sterile meat and poultry products into one new 
9 CFR part 431 and making minor changes to improve clarity and remove 
redundant requirements. As discussed earlier in this document, FSIS is 
removing the requirement for the Administrator's prior approval before 
an establishment may use an alternative time lapse between container 
closure and the initiation of the thermal process (9 CFR 318.301(f)(2); 
381.301(f)(2)). FSIS also is replacing the redundant descriptions of 
equipment (e.g., bleeders, vents) common to the several types of retort 
systems (batch still, batch agitating, continuous rotary, and 
hydrostatic) with a single paragraph that describes equipment common to 
all the systems (9 CFR 318.305 and 381.305).
    There are no additional costs associated with combining the canning 
regulations or with these other minor changes. FSIS is not implementing 
any new requirements for canning establishments and is providing 
additional flexibility by removing prior approval provisions.

Executive Order 13771

    This final rule is an E.O. 13771 deregulatory action. We have 
estimated that this final rule would yield cost savings.

Regulatory Flexibility Act Assessment

    The FSIS Administrator certifies that, for the purpose of the 
Regulatory Flexibility Act (5 U.S.C. 601-602), the final rule will not 
have a significant economic impact on a substantial number of small 
entities in the United States. The rule will affect 447 very small 
establishments and 222 small establishments that produce pork and pork 
products in the United States. FSIS is providing additional flexibility 
to these establishments. FSIS has developed a draft compliance guide 
designed to help small and very small establishments to understand the 
controls that are effective for the prevention and elimination of 
trichinae and other parasites in RTE and NRTE pork products. There are 
29 very small establishments and 80 small establishments that produce 
thermally processed, commercially sterile meat and poultry products in 
the United States. The final rule does not impose any additional costs 
on small and very small establishments because these establishments 
already are in compliance with the canning regulations, and combining 
the separate (meat and poultry) canning regulations into one part is an 
administrative action.

Paperwork Reduction Act

    There are no paperwork or recordkeeping requirements associated 
with this final rule under the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501-3520).

E-Government Act

    FSIS and USDA are committed to achieving the purposes of the E-
Government Act (44 U.S.C. 3601, et seq.) by, among other things, 
promoting the use of the internet and other information technologies 
and providing increased opportunities for citizen access to Government 
information and services, and for other purposes.

Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. Under this rule: (1) All State and local laws and 
regulations that are inconsistent with this rule will be preempted; (2) 
no retroactive effect will be given to this rule; and (3) no 
administrative proceedings will be required before parties may file 
suit in court challenging this rule.

Executive Order 13175

    This final rule has been reviewed in accordance with the 
requirements of Executive Order 13175, ``Consultation and Coordination 
with Indian Tribal Governments.'' E.O. 13175 requires Federal agencies 
to consult and coordinate with tribes on a government-to-government 
basis on policies that have tribal implications, including regulations, 
legislative comments or proposed legislation, and other policy 
statements or actions that have substantial direct effects on one or 
more Indian tribes, on the relationship between the Federal Government 
and Indian tribes or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes.
    FSIS has assessed the impact of this final rule on Indian tribes 
and determined that this rulemaking does not, to our knowledge, have 
tribal implications that require tribal consultation under E.O. 13175. 
If a Tribe requests consultation, the Food Safety and Inspection 
Service will work with the Office of Tribal Relations to ensure 
meaningful consultation is provided where changes, additions and 
modifications identified herein are not expressly mandated by Congress.

USDA Non-Discrimination Statement

    No agency, officer, or employee of the USDA will, on the grounds of 
race, color, national origin, religion, sex, gender identity, sexual 
orientation, disability, age, marital status, family/parental status, 
income derived from a public assistance program, or political beliefs, 
exclude from participation in, deny the benefits of, or subject to 
discrimination any person in the United States under any program or 
activity conducted by the USDA.

How To File a Complaint of Discrimination

    To file a complaint of discrimination, complete the USDA Program 
Discrimination Complaint Form, which may be accessed online at http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your 
authorized representative.
    Send your completed complaint form or letter to USDA by mail, fax, 
or email:
    Mail: U.S. Department of Agriculture, Director, Office of 
Adjudication, 1400 Independence Avenue SW, Washington, DC 20250-9410, 
Fax: (202) 690-7442, Email: [email protected].
    Persons with disabilities who require alternative means for 
communication (Braille, large print, audiotape, etc.), should contact 
USDA's TARGET Center at (202) 720-2600 (voice and TDD).

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication on-line through the FSIS web page located at: 
http://www.fsis.usda.gov/federal-register.
    FSIS also will make copies of this publication available through 
the FSIS Constituent Update, which is used to provide information 
regarding FSIS policies, procedures, regulations, Federal Register 
notices, FSIS public meetings, and other types of information that 
could affect or would be of interest to our constituents and 
stakeholders. The Update is available on the FSIS web page. Through the 
web page, FSIS is able to provide information to a much broader, more 
diverse audience. In

[[Page 25307]]

addition, FSIS offers an email subscription service which provides 
automatic and customized access to selected food safety news and 
information. This service is available at: http://www.fsis.usda.gov/subscribe. Options range from recalls to export information, 
regulations, directives, and notices. Customers can add or delete 
subscriptions themselves, and have the option to password protect their 
accounts.

List of Subjects

9 CFR Part 301

    Meat inspection.

9 CFR Part 303

    Meat inspection, Reporting and recordkeeping requirements.

9 CFR Part 318

    Food additives, Food packaging, Laboratories, Meat inspection, 
Reporting and recordkeeping requirements.

9 CFR Part 319

    Food grades and standards, Food labeling, Frozen foods, Meat 
inspection, Oils and fats.

9 CFR Part 320

    Meat inspection, Reporting and recordkeeping requirements.

9 CFR Part 325

    Meat inspection, Reporting and recordkeeping requirements, 
Transportation.

9 CFR Part 331

    Intergovernmental regulations, Meat inspection.

9 CFR Part 381

    Administrative practice and procedure, Animal diseases, Crime, 
Exports, Food grades and standards, Food labeling, Food packaging, 
Government employees, Grant programs--agriculture, Intergovernmental 
relations, Laboratories, Meat inspection, Nutrition, Polycholorinated 
biphenyls (PCB's), Poultry and poultry products inspection, Reporting 
and recordkeeping requirements.

9 CFR Part 417

    Meat inspection, Poultry and poultry products inspection, Reporting 
and recordkeeping requirements.

9 CFR Part 424

    Food additives, Food packaging, Meat inspection, Poultry and 
poultry products.

9 CFR Part 431

    Meat inspection, Poultry and poultry products inspection, Reporting 
and recordkeeping requirements.

9 CFR Part 548

    Fish, Food additives, Food grades and standards, Food packaging, 
Laboratories, Reporting and recordkeeping requirements, Signs and 
symbols.
    For the reasons set forth in the preamble, FSIS is amending title 
9, chapter III, of the Code of Federal Regulations as follows:

PART 301--TERMINOLOGY; ADULTERATION AND MISBRANDING STANDARDS

0
1. The authority citation for part 301 is revised to read as follows:

    Authority:  7 U.S.C. 1633, 1901-1906; 21 U.S.C. 601-695; 7 CFR 
2.7, 2.18, 2.53.


Sec.  301.2  [Amended]

0
2. Section 301.2 is amended in the definitions of ``Process authority'' 
and ``Process schedule'' by removing ``subpart G of part 318'' and 
adding in its place ``part 431 of this chapter.''

PART 303--EXEMPTIONS

0
3. The authority citation for part 303 is revised to read as follows:

    Authority:  21 U.S.C. 601-695; 7 CFR 2.18, 2.53.


Sec.  303.1  [Amended]

0
4. Section 303.1 is amended as follows:
0
a. In paragraph (b)(1) by removing ``318.10,'' from the first and 
second sentences.
0
b. In paragraph (f) by removing the second sentence.

PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND 
PREPARATION OF PRODUCTS

0
5. The authority citation for part 318 is revised to read as follows:

    Authority:  7 U.S.C. 1633, 1901-1906; 21 U.S.C. 601-695; 7 CFR 
2.18, 2.53.


Sec.  318.10  [Removed and reserved]

0
6. Section 318.10 is removed and reserved.

Subpart G--[Removed and reserved]

0
7. Subpart G, consisting of Sec. Sec.  318.300 through 318.311, is 
removed and reserved.

PART 319--DEFINITIONS AND STANDARDS OF IDENTITY AND COMPOSITION

0
8. The authority citation for part 319 is revised to read as follows:

    Authority:  7 U.S.C. 1633, 1901-1906; 21 U.S.C. 601-695; 7 CFR 
2.18, 2.53.


Sec.  319.106  [Amended]

0
9. In Sec.  319.106, paragraph (b) is removed, paragraphs (c)(5) and 
(6) are removed and reserved, and paragraphs (c) and (d) are 
redesignated as paragraphs (b) and (c), respectively.


Sec.  319.145  [Amended]

0
10. In Sec.  319.145, paragraph (a)(2) is amended by removing the third 
sentence.

PART 320--RECORDS, REGISTRATION, AND REPORTS

0
11. The authority citation for part 320 is revised to read as follows:

    Authority:  21 U.S.C. 601-695; 7 CFR 2.18, 2.53.

0
12. In Sec.  320.1, paragraph (b)(6) is revised, paragraph (b)(7) is 
removed, and paragraphs (b)(8) through (11) are redesignated as 
paragraphs (b)(7) through (10), respectively, to read as follows:


Sec.  320.1  Records required to be kept.

* * * * *
    (b) * * *
    (6) Records of canning as required by part 431 of this chapter.
* * * * *

PART 325--TRANSPORTATION

0
13. The authority citation for part 325 is revised to read as follows:

    Authority:  7 U.S.C. 1633, 1901-1906; 21 U.S.C. 601-695; 7 CFR 
2.18, 2.53.


Sec.  325.7  [Amended]

0
14. In Sec.  325.7, paragraph (a) is amended by removing the phrase 
``pork that has been refrigerated to destroy trichinae,''.

PART 331--SPECIAL PROVISIONS FOR DESIGNATED STATES AND TERRITORIES; 
AND FOR DESIGNATION OF ESTABLISHMENTS WHICH ENDANGER PUBLIC HEALTH 
AND FOR SUCH DESIGNATED ESTABLISHMENTS

0
15. The authority citation for part 331 is revised to read as follows:

    Authority:  21 U.S.C. 601-695; 7 CFR 2.18, 2.53.

[[Page 25308]]

Sec.  331.5  [Amended]

0
16. In Sec.  331.5, paragraph (a)(1)(ii) is amended by removing the 
phrase ``; or it is a ready-to-eat pork product which has not been 
treated to destroy trichinae as prescribed in Sec.  318.10 of this 
subchapter for products at federally inspected establishments''.

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

0
17. The authority citation for part 381 is revised to read as follows:

    Authority:  7 U.S.C. 1633, 1901-1906; 21 U.S.C. 451-472; 7 CFR 
2.18, 2.53.


0
18. In Sec.  381.175, paragraph (b)(3) is revised to read as follows:


Sec.  381.175   Records required to be kept.

* * * * *
    (b) * * *
    (3) Records of canning as required by part 431 of this chapter.
* * * * *

Subpart X--[Removed and reserved]

0
19. Subpart X, consisting of Sec. Sec.  381.300 through 381.311, is 
removed and reserved.

PART 417--HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) 
SYSTEMS

0
20. The authority citation for part 417 is revised to read as follows:

    Authority:  7 U.S.C. 1633, 1901-1906; 21 U.S.C. 451-472, 601-
695; 7 CFR 2.18, 2.53.


0
21. Section 417.2(b)(3) is revised to read as follows:


Sec.  417.2   Hazard Analysis and HACCP plan.

* * * * *
    (b) * * *
    (3) HACCP plans for thermally processed/commercially sterile 
products do not have to address the food safety hazards associated with 
microbiological contamination if the product is produced in accordance 
with the requirements of part 431 of this chapter.
* * * * *

PART 424--PREPARATION AND PROCESSING OPERATIONS

0
22. The authority citation for part 424 is revised to read as follows:

    Authority:  7 U.S.C. 1633, 1901-1906; 21 U.S.C. 451-472, 601-
695; 7 CFR 2.18, 2.53.


Sec.  424.21  [Amended]

0
23. In Sec.  424.21, paragraphs (a)(3)(ii) and (iii) are removed and 
paragraph (a)(3)(i) is redesignated as (a)(3).

0
24. Part 431 is added to read as follows:

PART 431--THERMALLY PROCESSED, COMMERCIALLY STERILE PRODUCTS

Sec.
431.1 Definitions.
431.2 Containers and closures.
431.3 Thermal processing.
431.4 Critical factors and the application of the process schedule.
431.5 Operations in the thermal processing area.
431.6 Equipment and procedures for heat processing systems.
431.7 Processing and production records.
431.8 Record review and maintenance.
431.9 Deviations in processing.
431.10 Finished product inspection.
431.11 Personnel and training.
431.12 Recall procedure.

    Authority:  7 U.S.C. 1633, 1901-1906; 21 U.S.C. 451-472, 601-
695; 7 CFR 2.18, 2.53.


Sec.  431.1   Definitions.

    Abnormal container. A container with any sign of swelling or 
product leakage or any evidence that the contents of the unopened 
container may be spoiled.
    Acidified low acid product. A canned product which has been 
formulated or treated so that every component of the finished product 
has a pH of 4.6 or lower within 24 hours after the completion of the 
thermal process unless data are available from the establishment's 
processing authority demonstrating that a longer time period is safe.
    Bleeders. Small orifices on a retort through which steam, other 
gasses, and condensate are emitted from the retort throughout the 
entire thermal process.
    Canned product. A meat or poultry food product with a water 
activity above 0.85 which receives a thermal process either before or 
after being packed in a hermetically sealed container. Unless otherwise 
specified, the term ``product'' as used in this part means ``canned 
product.''
    Closure technician. The individual(s) identified by the 
establishment as being trained to perform specific container integrity 
examinations as required by this part and designated by the 
establishment to perform such examinations.
    Code lot. All production of a particular product in a specific size 
container marked with a specific container code.
    Come-up time. The elapsed time, including venting time (if 
applicable), between the introduction of the heating medium into a 
closed retort and the start of process timing.
    Critical factor. Any characteristic, condition or aspect of a 
product, container, or procedure that affects the adequacy of the 
process schedule. Critical factors are established by processing 
authorities.
    Headspace. That portion of a container not occupied by the product.
    (1) Gross headspace. The vertical distance between the level of the 
product (generally the liquid surface) in an upright rigid container 
and the top edge of the container (i.e., the flange of an unsealed can, 
the top of the double seam on a sealed can, or the top edge of an 
unsealed jar).
    (2) Net headspace. The vertical distance between the level of the 
product (generally the liquid surface) in an upright rigid container 
and the inside surface of the lid.
    Hermetically sealed containers. Air-tight containers which are 
designed and intended to protect the contents against the entry of 
microorganisms during and after thermal processing.
    (1) Rigid container. A container, the shape or contour of which, 
when filled and sealed, is neither affected by the enclosed product nor 
deformed by external mechanical pressure of up to 10 pounds per square 
inch gauge (0.7 kg/cm\2\) (i.e., normal firm finger pressure).
    (2) Semirigid container. A container, the shape or contour of 
which, when filled and sealed, is not significantly affected by the 
enclosed product under normal atmospheric temperature and pressure, but 
can be deformed by external mechanical pressure of less than 10 pounds 
per square inch gauge (0.7 kg/cm\2\) (i.e., normal firm finger 
pressure).
    (3) Flexible container. A container, the shape or contour of which, 
when filled and sealed, is significantly affected by the enclosed 
product.
    Incubation tests. Tests in which the thermally processed product is 
kept at a specific temperature for a specified period of time in order 
to determine if outgrowth of microorganisms occurs.
    Initial temperature. The temperature, determined at the initiation 
of a thermal process cycle, of the contents of the coldest container to 
be processed.
    Low acid product. A canned product in which any component has a pH 
value above 4.6.
    Process schedule. The thermal process and any specified critical 
factors for a given canned product required to achieve shelf stability.
    Process temperature. The minimum temperature(s) of the heating 
medium to be maintained as specified in the process schedule.
    Process time. The intended time(s) a container is to be exposed to 
the heating medium while the heating medium is at or above the process 
temperature(s).
    Processing authority. The person(s) or organization(s) having 
expert knowledge of thermal processing requirements for foods in 
hermetically sealed containers,

[[Page 25309]]

having access to facilities for making such determinations, and 
designated by the establishment to perform certain functions as 
indicated in this part.
    Program employee. Any inspector or other individual employed by the 
Department or any cooperating agency who is authorized by the Secretary 
to do any work or perform any duty in connection with the Program.
    Retort. A pressure vessel designed for thermal processing of 
product packed in hermetically sealed containers.
    Seals. Those parts of a semirigid container and lid or of a 
flexible container that are fused together in order to hermetically 
close the container.
    Shelf stability. The condition achieved by application of heat, 
sufficient, alone or in combination with other ingredients and/or 
treatments, to render the product free of microorganisms capable of 
growing in the product at nonrefrigerated conditions (over 
50[emsp14][deg]F or 10 [deg]C) at which the product is intended to be 
held during distribution and storage. Shelf stability and shelf stable 
are synonymous with commercial sterility and commercially sterile, 
respectively.
    Thermal process. The heat treatment necessary to achieve shelf 
stability as determined by the establishment's processing authority. It 
is quantified in terms of:
    (1) Time(s) and temperature(s); or
    (2) Minimum product temperature.
    Venting. The removal of air from a retort before the start of 
process timing.
    Water activity. The ratio of the water vapor pressure of the 
product to the vapor pressure of pure water at the same temperature.


Sec.  431.2   Containers and closures.

    (a) Examination and handling of empty containers. (1) Empty 
containers, closures, and flexible pouch roll stock must be evaluated 
by the establishment to ensure that they are free of structural defects 
and damage that may affect product or container integrity. Such an 
examination should be based on a statistical sampling plan.
    (2) All empty containers, closures, and flexible pouch roll stock 
must be stored, handled, and conveyed in such a manner that will 
prevent damage that could affect the hermetic condition of the sealed 
container.
    (3) Just before filling, rigid containers must be cleaned to 
prevent incorporation of foreign matter into the finished product. 
Closures, semirigid containers, preformed flexible pouches, and 
flexible pouch roll stock contained in original wrappings do not need 
to be cleaned before use.
    (b) Closure examinations for rigid containers (cans)--(1) Visual 
examinations. A closure technician must visually examine the double 
seams formed by each closing machine head. When seam defects (e.g., 
cutovers, sharpness, knocked down flanges, false seams, droops) are 
observed, necessary corrective actions, such as adjusting or repairing 
the closing machine, must be taken. In addition to the double seams, 
the entire container must be examined for product leakage or obvious 
defects. A visual examination must be performed on at least one 
container from each closing machine head, and the observations, along 
with any corrective actions, must be recorded. Visual examinations must 
be conducted with sufficient frequency to ensure proper closure and 
should be conducted at least every 30 minutes of continuous closing 
machine operation. Additional visual examinations must be made by the 
closure technician at the beginning of production, immediately 
following every jam in the closing machine and after closing machine 
adjustment (including adjustment for changes in container size).
    (2) Teardown examinations. Teardown examinations of double seams 
formed by each closing machine head must be performed by a closure 
technician at a frequency sufficient to ensure proper closure. These 
examinations should be made at intervals of not more than 4 hours of 
continuous closing machine operation. At least one container from each 
closing head must be examined on the packer's end during each regular 
examination period. Examination results along with any necessary 
corrective actions, such as adjusting or repairing the closing machine, 
must be promptly recorded by the closure technician. The establishment 
must have container specification guidelines for double seam integrity 
on file and available for review by Program employees. A teardown 
examination of the can maker's end must be performed on at least one 
container selected from each closing machine during each examination 
period except when teardown examinations are made on incoming empty 
containers or when, in the case of self-manufactured containers, the 
containers are made in the vicinity of the establishment and the 
container plant records are made available to Program employees. 
Additional teardown examinations on the packer's end should be made at 
the beginning of production, immediately following every jam in a 
closing machine and after closing machine adjustment (including 
adjustment for a change in container size). The following procedures 
must be used in teardown examinations of double seams:
    (i) Dimensional measurement. One of the following two methods must 
be employed for dimensional measurements of the double seam.
    (A) Micrometer measurement. (1) For cylindrical containers, measure 
the following dimensions (Figure 1 to Sec.  431.2) at three points 
approximately 120 degrees apart on the double seam excluding and at 
least one-half inch from the side seam juncture:

    (i) Double seam length--W;
    (ii) Double seam thickness--S;
    (iii) Body hook length--BH; and
    (iv) Cover hook length--CH.
    (2) Maximum and minimum values for each dimensional measurement 
must be recorded by the closure technician.
BILLING CODE 3410-DM-P

[[Page 25310]]

[GRAPHIC] [TIFF OMITTED] TR31MY18.001

BILLING CODE 3410-DM-C
    (B) Seamscope or seam projector. Required measurements of the seam 
include thickness, body hook, and overlap.
    (ii) Seam thickness. Seam thickness must be obtained by micrometer. 
For cylindrical containers, at least two locations, excluding the side 
seam juncture, must be used to obtain the required measurements.
    (iii) Seam tightness. Regardless of the dimensional measurement 
method used to measure seam dimensions, at a minimum, the seam(s) 
examined must be stripped to assess the degree of wrinkling.
    (iv) Side seam juncture rating. Regardless of the dimensional 
measurement method used to measure seam dimensions, the cover hook must 
be stripped to examine the cover hook droop at the juncture for 
containers having side seams.
    (v) Examination of noncylindrical containers. Examination of 
noncylindrical containers (e.g., square, rectangular, ``D''-shaped, and 
irregularly-shaped) must be conducted as described in paragraphs 
(b)(2)(i), (ii), (iii), and (iv) of this section except that the 
required dimensional measurements must be made on the double seam at 
the points listed in the establishment's container specification 
guidelines.
    (c) Closure examinations for glass containers--(1) Visual 
examinations. A closure technician must visually assess the adequacy of 
the closures formed by each closing machine. When closure defects, such 
as loose or cocked caps, fractured or cracked containers and low vacuum 
jars, are observed, necessary corrective actions, such as adjusting or 
repairing the closing machine must be taken and recorded. In addition 
to the closures, the entire container must be examined for defects. 
Visual examinations must be made with sufficient frequency to ensure 
proper closure and should be conducted at least every 30 minutes of 
continuous closing machine operation. Additional visual examinations 
must be made by the closure technician and the observations recorded at 
the beginning of production, immediately following every jam in the 
closing machine, and after closing machine adjustment

[[Page 25311]]

(including adjustment for a change in container size).
    (2) Closure examinations and tests. Depending upon the container 
and closure, tests must be performed by a closure technician at a 
frequency sufficient to ensure proper closure. These examinations 
should be made either before or after thermal processing and at 
intervals of not more than 4 hours of continuous closing machine 
operation. At least one container from each closing machine must be 
examined during each regular examination period. Examination results 
along with any necessary corrective actions, such as adjusting or 
repairing the closing machine, must be promptly recorded by the closure 
technician. The establishment must have specification guidelines for 
closure integrity on file and available for review by Program 
employees. Additional closure examinations should be made at the 
beginning of production, immediately following every jam in the closing 
machine, and after closing machine adjustment (including adjustment for 
a change in container size).
    (d) Closure examinations for semi-rigid and flexible containers--
(1) Heat seals--(i) Visual examinations. A closure technician must 
visually examine the seals formed by each sealing machine. When sealing 
defects are observed, necessary corrective actions, such as adjusting 
or repairing the sealing machine, must be taken and recorded. In 
addition to examining the heat seals, the entire container must be 
examined for product leakage or obvious defects. Visual examinations 
must be performed before and after the thermal processing operation and 
with sufficient frequency to ensure proper closure. These examinations 
should be conducted at least in accordance with a statistical sampling 
plan. All defects noted and corrective actions taken must be promptly 
recorded.
    (ii) Physical tests. Tests determined by the establishment as 
necessary to assess container integrity must be conducted by the 
closure technician at a frequency sufficient to ensure proper closure. 
These tests must be performed after the thermal processing operation 
and should be made at least every 2 hours of continuous production. The 
establishment's acceptance guidelines for each test procedure must be 
on file and available for review by Program employees. Test results 
along with any necessary corrective actions, such as adjusting or 
repairing the sealing machine, must be recorded.
    (2) Recording. Double seams on semirigid or flexible containers 
must be examined and the results recorded as provided in paragraph (b) 
of this section. Any additional measurements specified by the container 
manufacturer must also be made and recorded.
    (e) Container coding. Each container must be marked with a 
permanent, legible, identifying code mark. The mark must, at a minimum, 
identify in code the product (unless the product name is lithographed 
or printed elsewhere on the container) and the day and year the product 
was packed.
    (f) Handling of containers after closure. (1) Containers and 
closures must be protected from damage which may cause defects that are 
likely to affect the hermetic condition of the containers. The 
accumulation of stationary containers on moving conveyors should be 
minimized to avoid damage to the containers.
    (2) The maximum time lapse between closure of containers and 
initiation of thermal processing must be 2 hours unless data are 
available from the establishment's processing authority demonstrating 
that an alternative time period is safe and will not result in product 
spoilage.


Sec.  431.3   Thermal processing.

    (a) Process schedules. Prior to the processing of canned product 
for distribution in commerce, an establishment must have a process 
schedule (as defined in Sec.  431.1) for each canned meat or poultry 
product to be packed by the establishment.
    (b) Source of process schedules. (1) Process schedules used by an 
establishment must be developed or determined by a processing 
authority.
    (2) Any change in product formulation, ingredients, or treatments 
that are not already incorporated in a process schedule and that may 
adversely affect either the product heat penetration profile or 
sterilization value requirements must be evaluated by the 
establishment's processing authority. If it is determined that any such 
change adversely affects the adequacy of the process schedule, the 
processing authority must amend the process schedule accordingly.
    (3) Complete records concerning all aspects of the development or 
determination of a process schedule, including any associated 
incubation tests, must be made available by the establishment to the 
Program employee upon request.
    (c) Submittal of process information. (1) Prior to the processing 
of canned product for distribution in commerce, the establishment must 
provide the inspector at the establishment with a list of the process 
schedules (including alternate schedules) along with any additional 
applicable information, such as the retort come-up operating procedures 
and critical factors.
    (2) Letters or other written communications from a processing 
authority recommending all process schedules must be maintained on file 
by the establishment. Upon request by Program employees, the 
establishment must make available such letters or written 
communications (or copies thereof). If critical factors are identified 
in the process schedule, the establishment must provide the inspector 
with a copy of the procedures for measuring, controlling, and recording 
these factors, along with the frequency of such measurements, to ensure 
that the critical factors remain within the limits used to establish 
the process schedule. Once submitted, the process schedules and 
associated critical factors and the procedures for measuring (including 
the frequency), controlling, and recording of critical factors must not 
be changed without the prior written submittal of the revised 
procedures (including supporting documentation) to the inspector at the 
establishment.


Sec.  431.4   Critical factors and the application of the process 
schedule.

    Critical factors specified in the process schedule must be 
measured, controlled, and recorded by the establishment to ensure that 
these factors remain within the limits used to establish the process 
schedule. Examples of factors that are often critical to process 
schedule adequacy may include:

    (a) General. (1) Maximum fill-in weight or drained weight;
    (2) Arrangement of pieces in the container;
    (3) Container orientation during thermal processing;
    (4) Product formulation;
    (5) Particle size;
    (6) Maximum thickness for flexible containers, and to some extent 
semirigid containers, during thermal processing;
    (7) Maximum pH;
    (8) Percent salt;
    (9) Ingoing (or formulated) nitrite level (ppm);
    (10) Maximum water activity; and
    (11) Product consistency or viscosity.
    (b) Continuous rotary and batch agitating retorts. (1) Minimum 
headspace; and
    (2) Retort reel speed.
    (c) Hydrostatic retorts. (1) Chain or conveyor speed.
    (2) [Reserved]
    (d) Steam/air retorts. (1) Steam/air ratio; and
    (2) Heating medium flow rate.

[[Page 25312]]

Sec.  431.5   Operations in the thermal processing area.

    (a) Posting of processes. Process schedules (or operating process 
schedules) for daily production, including minimum initial temperatures 
and operating procedures for thermal processing equipment, must be 
posted in a conspicuous place near the thermal processing equipment. 
Alternatively, such information must be available to the thermal 
processing system operator and the inspector.
    (b) Process indicators and retort traffic control. A system for 
product traffic control must be established to prevent product from 
bypassing the thermal processing operation. Each basket, crate, or 
similar vehicle containing unprocessed product, or at least one visible 
container in each vehicle, must be plainly and conspicuously marked 
with a heat sensitive indicator that will visually indicate whether 
such unit has been thermally processed. Exposed heat sensitive 
indicators attached to container vehicles must be removed before such 
vehicles are refilled with unprocessed product. Container loading 
systems for crateless retorts must be designed to prevent unprocessed 
product from bypassing the thermal processing operation.
    (c) Initial temperature. The initial temperature of the contents of 
the coldest container to be processed must be determined and recorded 
by the establishment at the time the processing cycle begins to assure 
that the temperature of the contents of every container to be processed 
is not lower than the minimum initial temperature specified in the 
process schedule. Thermal processing systems which subject the filled 
and sealed containers to water at any time before process timing begins 
must be operated to assure that such water will not lower the 
temperature of the product below the minimum initial temperature 
specified in the process schedule.
    (d) Timing devices. Devices used to time applicable thermal 
processing operation functions or events, such as process schedule 
time, come-up time, and retort venting, must be accurate to assure that 
all such functions or events are achieved. Pocket watches and wrist 
watches are not considered acceptable timing devices. Analog and 
digital clocks are considered acceptable. If such clocks do not display 
seconds, all required timed functions or events must have at least a 1-
minute safety factor over the specified thermal processing operation 
times. Temperature/time recording devices must correspond within 15 
minutes to the time of the day recorded on written records required by 
Sec.  431.7.
    (e) Measurement of pH. Unless other methods are approved by the 
Administrator, potentiometric methods using electronic instruments (pH 
meters) must be used for making pH determinations when a maximum pH 
value is specified as a critical factor in a process schedule.


Sec.  431.6   Equipment and procedures for heat processing systems.

    (a) Instruments and controls common to different thermal processing 
systems--(1) Indicating temperature devices. Each retort must be 
equipped with at least one indicating temperature device that measures 
the actual temperature within the retort. The indicating temperature 
device, not the temperature/time recording device, must be used as the 
reference instrument for indicating the process temperature.
    (i) Mercury-in-glass thermometers. A mercury-in-glass thermometer 
must have divisions that are readable to 1[emsp14][deg]F (or 0.5 
[deg]C) and whose scale contains not more than 17[emsp14][deg]F/inch 
(or 4.0 [deg]C/cm) of graduated scale. Each mercury-in-glass 
thermometer must be tested for accuracy against a known accurate 
standard upon installation and at least once a year to ensure its 
accuracy. Records that specify the date, standard used, test method, 
and the person or testing authority performing the test must be 
maintained on file by the establishment and made available to Program 
employees. A mercury-in-glass thermometer that has a divided mercury 
column or that cannot be adjusted to the standard must be repaired and 
tested for accuracy before further use, or replaced.
    (ii) Other devices. Temperature-indicating devices, such as 
resistance temperature detectors, used in lieu of mercury-in-glass 
thermometers, must meet known, accurate standards for such devices when 
tested for accuracy. The records of such testing must be available to 
FSIS program employees.
    (2) Temperature/time recording devices. Each thermal processing 
system must be equipped with at least one temperature/time recording 
device to provide a permanent record of temperatures within the thermal 
processing system. This recording device may be combined with the steam 
controller and may be a recording/controlling instrument. When compared 
to the known accurate indicating temperature device, the recording 
accuracy must be equal to or better than 1[emsp14][deg]F (or 0.5 
[deg]C) at the process temperature. The temperature recording chart 
should be adjusted to agree with, but must never be higher than, the 
known accurate indicating temperature device. A means of preventing 
unauthorized changes in the adjustment must be provided. For example, a 
lock or a notice from management posted at or near the recording device 
warning that only authorized persons are permitted to make adjustments, 
are satisfactory means for preventing unauthorized changes. Air-
operated temperature controllers must have adequate filter systems to 
ensure a supply of clean, dry air. The recorder timing mechanism must 
be accurate.
    (i) Chart-type devices. Devices using charts must be used only with 
the correct chart. Each chart must have a working scale of not more 
than 55[emsp14][deg]F/inch (or 12 [deg]C/cm.) within a range of 
20[emsp14][deg]F (or 11 [deg]C) of the process temperature. Chart 
graduations must not exceed 2[emsp14][deg]F degrees (or 1 [deg]C) 
within a range of 10[emsp14][deg]F (or 5 [deg]C) of the process 
temperature. Multipoint plotting chart-type devices must print 
temperature readings at intervals that will assure that the parameters 
of the process time and process temperature have been met. The 
frequency of recording should not exceed 1-minute intervals.
    (ii) Other devices. Temperature/time recording devices or 
procedures used in lieu of chart-type devices must meet known accurate 
standards for such devices or procedures when tested for accuracy. Such 
a device must be accurate enough for ensuring that process time and 
temperature parameters have been met.
    (3) Steam controllers. Each retort must be equipped with an 
automatic steam controller to maintain the retort temperature. This may 
be a recording/controlling instrument when combined with a temperature/
time recording device.
    (4) Air valves. All air lines connected to retorts designed for 
pressure processing in steam must be equipped with a globe valve or 
other equivalent-type valve or piping arrangement that will prevent 
leakage of air into the retort during the process cycle.
    (5) Water valves. All retort water lines that are intended to be 
closed during a process cycle must be equipped with a globe valve or 
other equivalent-type valve or piping arrangement that will prevent 
leakage of water into the retort during the process cycle.
    (b) Pressure processing in steam--(1) Common to batch still, batch 
agitating, continuous rotary retorts, and hydrostats--(i) Basic 
requirements. The basic requirements and recommendations for indicating 
temperature devices and temperature/time recording devices are 
described in

[[Page 25313]]

paragraphs (a)(1) and (2) of this section. Additionally, bulb sheaths 
or probes of indicating temperature devices and probes of temperature/
time recording devices must be installed either within the retort shell 
or in external wells attached to the retort. External wells must be 
connected to the retort through at least a \3/4\ inch (1.9 cm) diameter 
opening and equipped with a \1/16\ inch (1.6 mm) or larger bleeder 
opening so located as to provide a constant flow of steam past the 
length of the bulb or probe. The bleeder for the external wells must 
emit steam continuously during the entire thermal processing period.
    (ii) Steam inlet. The steam inlet to each retort must be large 
enough to provide steam for proper operation of the retort, and must 
enter at a point(s) to facilitate air removal during venting.
    (iii) Bleeder and vent mufflers. If mufflers are used on bleeders 
or vent systems, the establishment must have on file documentation that 
the mufflers do not impede the removal of air from the retort. Such 
documentation must consist of either heat distribution data or 
documentation from the muffler manufacturer or from a processing 
authority. This information must be made available to Program employees 
for review.
    (iv) Bleeders. Bleeders, except those for external wells of 
temperature devices and hydrostatic retorts, must have a \1/8\ inch (or 
3 mm) or larger openings and must be wide open during the entire 
process, including the come-up time. All bleeders must be arranged so 
that the retort operator can observe that they are functioning 
properly. For horizontal retorts, batch agitating retorts, and 
continuous rotary retorts, bleeders must be located within 
approximately 1 foot (or 30 cm) of the outmost locations of containers 
at each end along the top of the retort. Additional bleeders must be 
located not more than 8 feet (2.4 m) apart along the top. This 
information must be maintained on file by the establishment and made 
available to Program employees for review. Vertical retorts must have 
at least one bleeder opening located in the portion of the retort 
opposite the steam inlet. Hydrostatic retorts must have bleeder 
openings \1/4\ inch (or 6 mm) or larger which are to be located in the 
steam chamber(s) opposite the point of steam entry. Bleeders may be 
installed at positions other than those specified above, as long as the 
establishment has heat distribution data or other documentation from 
the manufacturer or from a processing authority demonstrating that the 
bleeders accomplish removal of air and circulate the steam within the 
retort.
    (2) Batch still retorts--(i) Crate supports. Vertical still retorts 
with bottom steam entry must employ bottom retort crate supports. 
Baffle plates must not be used in the bottom of retorts.
    (ii) Steam spreader. Perforated steam spreaders, if used, must be 
maintained to ensure they are not blocked or otherwise inoperative. 
Horizontal still retorts must be equipped with perforated steam 
spreaders that extend the full length of the retort unless the adequacy 
of another arrangement is documented by heat distribution data or other 
documentation from a processing authority. Such information must be 
maintained on file by the establishment and made available to Program 
employees for review.
    (iii) Condensate removal. In retorts having a steam inlet above the 
level of the lowest container, a bleeder must be installed in the 
bottom of the retort to remove condensate. The condensate bleeder must 
be so arranged that the retort operator can observe that it is 
functioning properly. The condensate bleeder must be checked with 
sufficient frequency to ensure adequate removal of condensate. Visual 
checks should be performed at intervals of not more than 15 minutes and 
the results recorded. Intermittent condensate removal systems must be 
equipped with an automatic alarm system that will serve as a continuous 
monitor of condensate bleeder functioning. The automatic alarm system 
must be tested at the beginning of each shift for proper functioning 
and the results recorded. If the alarm system is not functioning 
properly, it must be repaired before the retort is used.
    (iv) Stacking equipment--(A) Equipment for holding or stacking 
containers in retorts. Crates, trays, gondolas, carts, and other 
vehicles for holding or stacking product containers in the retort must 
be so constructed to ensure steam circulation during the venting, come-
up, and process times. The bottom of each vehicle must have 
perforations at least 1 inch (2.5 cm) in diameter on 2 inch (or 5 cm) 
centers or the equivalent unless the adequacy of another arrangement is 
documented by heat distribution data or other documentation from a 
processing authority and such information is maintained on file by the 
establishment and made available to Program employees for review.
    (B) Divider plates. Whenever one or more divider plates are used 
between any two layers of containers or placed on the bottom of a 
retort vehicle, the establishment must have on file documentation that 
the venting procedure allows the air to be removed from the retort 
before timing of the thermal process is started. Such documentation 
must be in the form of heat distribution data or documentation from a 
processing authority. This information must be made available to 
Program employees for review.
    (v) Vents. (A) Vents must be located in that portion of the retort 
opposite the steam inlet and must be designed, installed, and operated 
in such a way that air is removed from the retort before timing of the 
thermal process is started. Vents must be controlled by a gate, plug 
cock, or other full-flow valve which must be fully opened to permit 
rapid removal of air from retorts during the venting period.
    (B) Vents must not be connected to a closed drain system without an 
atmospheric break in the line. Where a retort manifold connects several 
pipes from a single retort, the manifold must be controlled by a gate, 
plug cock, or other full-flow valve and the manifold must be of a size 
such that the cross-sectional area of the manifold is larger than the 
total cross-sectional area of all connecting vents. The discharge must 
not be connected to a closed drain without an atmospheric break in the 
line. A manifold header connecting vents or manifolds from several 
still retorts must lead to the atmosphere. The manifold header must not 
be controlled by a valve and must be of a size such that the cross-
sectional area is at least equal to the total cross-sectional area of 
all connecting retort manifold pipes from the maximum number of retorts 
to be vented simultaneously.
    (C) Some typical installations and operating procedures are 
described below. Other retort installations, vent piping arrangements, 
operating procedures or auxiliary equipment such as divider plates may 
be used provided there is documentation that the air is removed from 
the retort before the process is started. Such documentation must be in 
the form of heat distribution data or other documentation from the 
equipment manufacturer or processing authority. This information must 
be maintained on file by the establishment and made available to 
Program employees for review.
    (D) For crateless retort installations, the establishment must have 
heat distribution data or other documentation from the equipment 
manufacturer or from a processing authority that demonstrates that the 
venting procedure used accomplishes the removal of air and condensate. 
This information must be maintained on file

[[Page 25314]]

by the establishment and made available to Program employees for 
review.
    (E) Examples of typical installations and operating procedures that 
comply with the requirements of this section are as follows:
    (1) Venting horizontal retorts. (i) Venting through multiple 1 inch 
(2.5 cm) vents discharging directly to the atmosphere.
BILLING CODE 3410-DM-P
[GRAPHIC] [TIFF OMITTED] TR31MY18.002

    (ii) Venting through multiple 1 inch (2.5 cm) vents discharging 
through a manifold to the atmosphere.

[[Page 25315]]

[GRAPHIC] [TIFF OMITTED] TR31MY18.003

    (iii) Venting through water spreaders.

[[Page 25316]]

[GRAPHIC] [TIFF OMITTED] TR31MY18.004

    (iv) Venting through a single 2\1/2\ inch (6.4 cm) top vent for 
retorts not exceeding 15 feet (4.6 m) in length.

[[Page 25317]]

[GRAPHIC] [TIFF OMITTED] TR31MY18.005

    (2) Venting vertical retorts. (i) Venting through a 1\1/2\ inch 
(3.8 cm) overflow.

[[Page 25318]]

[GRAPHIC] [TIFF OMITTED] TR31MY18.006

    (ii) Venting through a single 1 inch (2.5 cm) side or top vent.

[[Page 25319]]

[GRAPHIC] [TIFF OMITTED] TR31MY18.007

BILLING CODE 3410-DM-C
    (3) Batch agitating retorts--(i) Venting and condensate removal. 
The air in the retort must be removed before processing is started. 
Heat distribution data or other documentation from the manufacturer or 
from the processing authority who developed the venting procedure must 
be kept on file by the establishment and made available to Program 
employees for review. At the time the steam is turned on, the drain 
must be opened to remove steam condensate from the retort. A bleeder 
must be installed in the bottom of the retort to remove condensate 
during retort operation. The condensate bleeder must be so arranged 
that the retort operator can observe that it is functioning properly. 
The condensate bleeder must be checked with sufficient frequency to 
ensure adequate removal of condensate. Visual checks should be 
performed at intervals of not more than 15 minutes and the results 
recorded. Intermittent condensate removal systems must be equipped with 
an automatic alarm system that will serve as a continuous monitor of 
condensate bleeder functioning. The automatic alarm system must be 
tested at the beginning of each shift for proper functioning and the 
results recorded. If the alarm system is not functioning properly, it 
must be repaired before the retort is used.

[[Page 25320]]

    (ii) Retort or reel speed timing. The retort or reel speed must be 
checked before process timing begins and, if needed, adjusted as 
specified in the process schedule. In addition, the rotational speed 
must be determined and recorded at least once during process timing of 
each retort load processed. Alternatively, a recording tachometer can 
be used to provide a continuous record of the speed. The accuracy of 
the recording tachometer must be determined and recorded at least once 
per shift by checking the retort or reel speed using an accurate 
stopwatch. A means of preventing unauthorized speed changes on retorts 
must be provided. For example, a lock or a notice from management 
posted at or near the speed adjustment device warning that only 
authorized persons are permitted to make adjustments is a satisfactory 
means of preventing unauthorized changes.
    (4) Continuous rotary retorts--(i) Venting and condensate removal. 
The air in the retort must be removed before processing is started. 
Heat distribution data or other documentation from the manufacturer or 
from the processing authority who developed the venting procedure must 
be kept on file by the establishment and made available to Program 
employees for review. At the time the steam is turned on, the drain 
must be opened to remove steam condensate from the retort. A bleeder 
must be installed in the bottom of the shell to remove condensate 
during the retort operation. The condensate bleeder must be so arranged 
that the retort operator can observe that it is functioning properly. 
The condensate bleeder must be checked with sufficient frequency to 
ensure adequate removal of condensate. Visual checks should be 
performed at intervals of not more than 15 minutes and the results 
recorded. Intermittent condensate removal systems must be equipped with 
an automatic alarm system that will serve as a continuous monitor of 
condensate bleeder functioning. The automatic alarm system must be 
tested at the beginning of each shift for proper functioning and the 
results recorded. If the alarm system is not functioning properly, it 
must be repaired before the retort is used.
    (ii) Retort speed timing. The rotational speed of the retort must 
be specified in the process schedule. The speed must be adjusted as 
specified, and recorded by the establishment when the retort is 
started, and checked and recorded at intervals not to exceed 4 hours to 
ensure that the correct retort speed is maintained. Alternatively, a 
recording tachometer may be used to provide a continuous record of the 
speed. If a recording tachometer is used, the speed must be manually 
checked against an accurate stopwatch at least once per shift and the 
results recorded. A means of preventing unauthorized speed changes on 
retorts must be provided. For example, a lock or a notice from 
management posted at or near the speed adjustment device warning that 
only authorized persons are permitted to make adjustments is a 
satisfactory means of preventing unauthorized changes.
    (5) Hydrostatic retorts--(i) Basic requirements. The basic 
requirements for indicating temperature devices and temperature/time 
recording devices are described in paragraphs (a)(1) and (2) of this 
section. Additionally, indicating temperature devices must be located 
in the steam dome near the steam/water interface. Where the process 
schedule specifies maintenance of particular water temperatures in the 
hydrostatic water legs, at least one indicating temperature device must 
be located in each hydrostatic water leg so that it can accurately 
measure water temperature and be easily read. The temperature/time 
recorder probe must be installed either within the steam dome or in a 
well attached to the dome. Each probe must have a \1/16\ inch (1.6 mm) 
or larger bleeder opening which emits steam continuously during the 
processing period. Additional temperature/time recorder probes must be 
installed in the hydrostatic water legs if the process schedule 
specifies maintenance of particular temperatures in these water legs.
    (ii) Steam inlet. The steam inlets must be large enough to provide 
steam for proper operation of the retort.
    (iii) Bleeders. Bleeder openings \1/4\ inch (or 6 mm) or larger 
must be located in the steam chamber(s) opposite the point of steam 
entry. Bleeders must be wide open and must emit steam continuously 
during the entire process, including the come-up time. All bleeders 
must be arranged in such a way that the operator can observe that they 
are functioning properly.
    (iv) Venting. Before the start of processing operations, the retort 
steam chamber(s) must be vented to ensure removal of air. Heat 
distribution data or other documentation from the manufacturer or from 
a processing authority demonstrating that the air is removed from the 
retort prior to processing must be kept on file at the establishment 
and made available to Program employees for review.
    (v) Conveyor speed. The conveyor speed must be calculated to obtain 
the required process time and recorded by the establishment when the 
retort is started. The speed must be checked and recorded at intervals 
not to exceed 4 hours to ensure that the correct conveyor speed is 
maintained. A recording device may be used to provide a continuous 
record of the conveyor speed. When a recording device is used, the 
speed must be manually checked against an accurate stopwatch at least 
once per shift by the establishment. A means of preventing unauthorized 
speed changes of the conveyor must be provided. For example, a lock or 
a notice from management posted at or near the speed adjustment device 
warning that only authorized persons are permitted to make adjustments 
is a satisfactory means of preventing unauthorized changes.
    (vi) Bleeders and vent mufflers. If mufflers are used on bleeders 
or vent systems, the establishment must have documentation that the 
mufflers do not impede the removal of air from the retort. Such 
documentation must consist of either heat distribution data or other 
documentation from the muffler manufacturer or from a processing 
authority. This information must be maintained on file by the 
establishment and made available to Program employees for review.
    (c) Pressure processing in water--(1) Common to batch still and 
agitating retorts--(i) Basic requirements. The basic requirements for 
indicating temperature devices and temperature/time recording devices 
are described in paragraphs (a)(1) and (2) of this section.
    (ii) Pressure recording device. Each retort must be equipped with a 
pressure recording device which may be combined with a pressure 
controller.
    (iii) Heat distribution. Heat distribution data or other 
documentation from the equipment manufacturer or a processing authority 
demonstrating uniform heat distribution within the retort must be kept 
on file at the establishment and made available to Program employees 
for review.
    (iv) Drain valve. A non-clogging, water-tight drain valve must be 
used. Screens must be installed over all drain openings.
    (2) Batch still retorts--(i) Temperature device bulbs and probes. 
The indicating temperature device bulbs or probes must be located in 
such a position that they are beneath the surface of the water 
throughout the process. On horizontal retorts, the indicating 
temperature device bulb or probe must be inserted directly into the 
retort shell. In both vertical and horizontal retorts, the indicating 
temperature device bulb or probe must extend directly into the water a 
minimum of 2 inches (or 5 cm)

[[Page 25321]]

without a separable well or sleeve. In vertical retorts equipped with a 
recorder/controller, the controller probe must be located at the bottom 
of the retort below the lowest crate rest in such a position that the 
steam does not strike it directly. In horizontal retorts so equipped, 
the controller probe must be located between the water surface and the 
horizontal plane passing through the center of the retort so that there 
is no opportunity for direct steam impingement on the controller probe. 
Air-operated temperature controllers must have filter systems to ensure 
a supply of clean, dry air.
    (ii) Crate supports. A bottom crate support must be used in 
vertical retorts. Baffle plates must not be used in the bottom of the 
retort.
    (iii) Stacking equipment. For filled flexible containers and, where 
applicable, semi-rigid containers, stacking equipment must be designed 
to ensure that the thickness of the filled containers does not exceed 
that specified in the process schedule and that the containers do not 
become displaced and overlap or rest on one another during the thermal 
process.
    (iv) Water level. There must be a means of determining the water 
level in the retort during operation (i.e., by using a gauge, 
electronic sensor, or sight glass indicator). For retorts requiring 
complete immersion of containers, water must cover the top layer of 
containers during the entire come-up time and thermal processing 
periods and should cover the top layer of containers during cooling. 
For retorts using cascading water or water sprays, the water level must 
be maintained within the range specified by the retort manufacturer or 
processing authority during the entire come-up, thermal processing, and 
cooling periods. A means to ensure that water circulation continues as 
specified throughout the come-up, thermal processing, and cooling 
periods must be provided. The retort operator must check and record the 
water level at intervals to ensure it meets the specified processing 
parameters.
    (v) Air supply and controls. In both horizontal and vertical still 
retorts, a means must be provided for introducing compressed air or 
steam at the pressure required to maintain container integrity. 
Compressed air and steam entry must be controlled by an automatic 
pressure control unit. A non-return valve must be provided in the air 
supply line to prevent water from entering the system. Overriding air 
or steam pressure must be maintained continuously during the come-up, 
thermal processing, and cooling periods. If air is used to promote 
circulation, it must be introduced into the steam line at a point 
between the retort and the steam control valve at the bottom of the 
retort. The adequacy of the air circulation for maintaining uniform 
heat distribution within the retort must be documented by heat 
distribution data or other documentation from a processing authority, 
and such data must be maintained on file by the establishment and made 
available to Program employees for review.
    (vi) Water recirculation. When a water recirculation system is used 
for heat distribution, the water must be drawn from the bottom of the 
retort through a suction manifold and discharged through a spreader 
that extends the length or circumference of the top of the retort. The 
holes in the water spreader must be uniformly distributed. The suction 
outlets must be protected with screens to keep debris from entering the 
recirculation system. The pump must be equipped with a pilot light or a 
similar device to warn the operator when it is not running, and with a 
bleeder to remove air when starting operations. Alternatively, a flow-
meter alarm system can be used to ensure proper water circulation. The 
adequacy of water circulation for maintaining uniform heat distribution 
within the retort must be documented by heat distribution or other 
documentation from a processing authority, and such data must be 
maintained on file by the establishment and made available to Program 
employees for review. Alternative methods for recirculation of water in 
the retort may be used, provided there is documentation in the form of 
heat distribution data or other documentation from a processing 
authority maintained on file by the establishment and made available to 
Program employees for review.
    (vii) Cooling water entry. In retorts for processing product packed 
in glass jars, the incoming cooling water should not directly strike 
the jars, in order to minimize glass breakage by thermal shock.
    (3) Batch agitating retorts--(i) Temperature device bulbs and 
probes. The indicating temperature device bulb or probe must extend 
directly into the water without a separable well or sleeve. The 
recorder/controller probe must be located between the water surface and 
the horizontal plane passing through the center of the retort so that 
there is no opportunity for steam to directly strike the controller 
bulb or probe.
    (ii) Stacking equipment. All devices used for holding product 
containers (e.g., crates, trays, divider plates) must be so constructed 
to allow the water to circulate around the containers during the come-
up and thermal process periods.
    (iii) Water level. There must be a means of determining the water 
level in the retort during operation (i.e., by using a gauge, 
electronic sensor, or sight glass indicator). Water must completely 
cover all containers during the entire come-up, thermal processing, and 
cooling periods. A means to ensure that water circulation continues as 
specified throughout the come-up, thermal processing, and cooling 
periods must be provided. The retort operator must check and record the 
adequacy of the water level with sufficient frequency to ensure it 
meets the specified processing parameters.
    (iv) Air supply and controls. Retorts must be provided with a means 
for introducing compressed air or steam at the pressure required to 
maintain container integrity. Compressed air and steam entry must be 
controlled by an automatic pressure control unit. A non-return valve 
must be provided in the air supply line to prevent water from entering 
the system. Overriding air or steam pressure must be maintained 
continuously during the come-up, thermal processing, and cooling 
periods. If air is used to promote circulation, it must be introduced 
into the steam line at a point between the retort and the steam control 
valve at the bottom of the retort. The adequacy of the air circulation 
for maintaining uniform heat distribution within the retort must be 
documented by heat distribution data or other documentation from a 
processing authority, and such data must be maintained on file by the 
establishment and made available to Program employees for review.
    (v) Retort or reel speed timing. The retort or reel speed timing 
must be checked before process timing begins and, if needed, adjusted 
as specified in the process schedule. In addition, the rotational speed 
must be determined and recorded at least once during process timing of 
each retort load processed. Alternatively, a recording tachometer can 
be used to provide a continuous record of the speed. The accuracy of 
the recording tachometer must be determined and recorded at least once 
per shift by the establishment by checking the retort or reel speed 
using an accurate stopwatch. A means of preventing unauthorized speed 
changes on retorts must be provided. For example, a lock or a notice 
from management posted at or near the speed adjustment device warning 
that only authorized persons are permitted to make adjustments is a 
satisfactory

[[Page 25322]]

means of preventing unauthorized changes.
    (vi) Water recirculation. If a water recirculation system is used 
for heat distribution, it must be installed in such a manner that water 
will be drawn from the bottom of the retort through a suction manifold 
and discharged through a spreader which extends the length of the top 
of the retort. The holes in the water spreader must be uniformly 
distributed. The suction outlets must be protected with screens to keep 
debris from entering the recirculation system. The pump must be 
equipped with a pilot light or a similar device to warn the operator 
when it is not running and with a bleeder to remove air when starting 
operations. Alternatively, a flow-meter alarm system can be used to 
ensure proper water circulation. The adequacy of water circulation for 
maintaining uniform heat distribution within the retort must be 
documented by heat distribution data or other documentation from a 
processing authority, and such data must be maintained on file by the 
establishment and made available to Program employees for review. 
Alternative methods for recirculation of water in the retort may be 
used provided there is documentation in the form of heat distribution 
data or other documentation from a processing authority maintained on 
file by the establishment and made available to Program employees for 
review.
    (vii) Cooling water entry. In retorts for processing product packed 
in glass jars, the incoming cooling water should not directly strike 
the jars, in order to minimize glass breakage by thermal shock.
    (d) Pressure processing with steam/air mixtures in batch retorts--
(1) Basic requirements. The basic requirements for indicating 
temperature devices and temperature/time recording devices are 
described in paragraphs (a)(1) and (2) of this section. Additionally, 
bulb sheaths or probes for indicating temperature devices and 
temperature/time recording devices or controller probes must be 
inserted directly into the retort shell in such a position that steam 
does not strike them directly.
    (2) Recording pressure controller. A recording pressure controller 
must be used to control the air inlet and the steam/air mixture outlet.
    (3) Circulation of steam/air mixtures. A means must be provided for 
the circulation of the steam/air mixture to prevent formation of low-
temperature pockets. The efficiency of the circulation system must be 
documented by heat distribution data or other documentation from a 
processing authority, and such data must be maintained on file by the 
establishment and made available to Program employees for review. The 
circulation system must be checked to ensure its proper functioning and 
must be equipped with a pilot light or a similar device to warn the 
operator when it is not functioning. Because of the variety of existing 
designs, reference must be made to the equipment manufacturer for 
details of installation, operation, and control.
    (e) Atmospheric cookers--(1) Temperature/time recording device. 
Each atmospheric cooker (e.g., hot water bath) must be equipped with at 
least one temperature/time recording device in accordance with the 
basic requirements described in paragraph (a)(2) of this section.
    (2) Heat distribution. Each atmospheric cooker must be equipped and 
operated to ensure uniform heat distribution throughout the processing 
system during the thermal process. Heat distribution data or other 
documentation from the manufacturer or a processing authority 
demonstrating uniform heat distribution within the cooker must be kept 
on file by the establishment and made available to Program employees 
for review.
    (f) Other systems. All other systems not specifically delineated in 
this section and used for the thermal processing of canned product must 
be adequate to produce shelf-stable products consistently and 
uniformly.
    (g) Equipment maintenance. (1) Upon installation, all 
instrumentation and controls must be checked by the establishment for 
proper functioning and accuracy and, thereafter, at any time their 
functioning or accuracy is suspect.
    (2) At least once a year each thermal processing system must be 
examined by an individual not directly involved in daily operations to 
ensure the proper functioning of the system as well as all auxiliary 
equipment and instrumentation. In addition, each thermal processing 
system should be examined before the resumption of operation following 
an extended shutdown.
    (3) Air and water valves that are intended to be closed during 
thermal processing must be checked by the establishment for leaks. 
Defective valves must be repaired or replaced as needed.
    (4) Vent and bleeder mufflers must be checked and maintained or 
replaced by the establishment to prevent any reduction in bleeder 
efficiency.
    (5) When water spreaders are used for venting, a maintenance 
schedule must be developed and implemented to assure that the holes are 
maintained at their original size.
    (6) Records must be kept on all maintenance items that could affect 
the adequacy of the thermal process. Records must include the date and 
type of maintenance performed and the person conducting the 
maintenance.
    (h) Container cooling and cooling water. (1) Potable water must be 
used for cooling except as provided for in paragraphs (h)(2) and (3) of 
this section.
    (2) Cooling canal water must be chlorinated or treated with a 
chemical having a bactericidal effect equivalent to chlorination. There 
must be a measurable residual of the sanitizer in the water at the 
discharge point of the canal. Cooling canals must be cleaned and 
replenished with potable water to prevent the buildup of organic matter 
and other materials.
    (3) Container cooling waters that are recycled or reused must be 
handled in systems that are so designed, operated, and maintained so 
there is no buildup of microorganisms, organic matter, and other 
materials in the systems and in the waters. System equipment, such as 
pipelines, holding tanks and cooling towers, must be constructed and 
installed so that they can be cleaned and inspected. In addition, the 
establishment must maintain, and make available to Program employees 
for review, information on at least the following:
    (i) System design and construction;
    (ii) System operation including the rates of renewal with fresh, 
potable water and the means for treating the water so that there is a 
measurable residual of an acceptable sanitizer, per paragraph (h)(2) of 
this section, in the water at the point where the water exits the 
container cooling vessel;
    (iii) System maintenance including procedures for the periodic 
cleaning and sanitizing of the entire system; and
    (iv) Water quality standards, such as microbiological, chemical and 
physical, monitoring procedures including the frequency and site(s) of 
sampling, and the corrective actions taken when water quality standards 
are not met.
    (i) Post-process handling of containers. Containers must be handled 
in a manner that will prevent damage to the hermetic seal area. All 
worn and frayed belting, can retarders, cushions, and the like must be 
replaced with nonporous materials. To minimize container abrasions, 
particularly in the seal area, containers should not remain stationary 
on moving conveyors. All post-process container handling equipment 
should be kept clean so there is no buildup of microorganisms on 
surfaces in contact with the containers.

[[Page 25323]]

Sec.  431.7  Processing and production records.

    At least the following processing and production information must 
be recorded by the establishment: Date of production; product name and 
style; container code; container size and type; and the process 
schedule, including the minimum initial temperature. Measurements made 
to satisfy the requirements of Sec.  431.4 regarding the control of 
critical factors must be recorded. In addition, where applicable, the 
following information and data must also be recorded:
    (a) Processing in steam--(1) Batch still retorts. For each retort 
batch, record the retort number or other designation, the approximate 
number of containers or the number of retort crates per retort load, 
product initial temperature, time steam on, the time and temperature 
vent closed, the start of process timing, time steam off, and the 
actual processing time. The indicating temperature device and the 
temperature recorder must be read at the same time at least once during 
process timing and the observed temperatures recorded.
    (2) Batch agitating retorts. In addition to recording the 
information required for batch still steam retorts in paragraph (a)(1) 
of this section, record the functioning of the condensate bleeder(s) 
and the retort or reel speed.
    (3) Continuous rotary retorts. Record the retort system number, the 
approximate total number of containers retorted, product initial 
temperature, time steam on, the time and temperature vent closed, time 
process temperature reached, the time the first can enters and the time 
the last can exits the retort. The retort or reel speed must be 
determined and recorded at intervals not to exceed 4 hours. Readings of 
the indicating temperature device(s) and temperature recorder(s) must 
be made and recorded at the time the first container enters the retort 
and thereafter with sufficient frequency to ensure compliance with the 
process schedule. These observations should be made and recorded at 
intervals not exceeding 30 minutes of continuous retort operation. 
Functioning of the condensate bleeder(s) must be observed and recorded 
at the time the first container enters the retort and thereafter as 
specified in Sec.  431.305(b)(3)(v).
    (4) Hydrostatic retorts. Record the retort system number, the 
approximate total number of containers retorted, product initial 
temperature, time steam on, the time and temperature vent(s) closed, 
time process temperature reached, time first containers enter the 
retort, time last containers exit the retort, and, if specified in the 
process schedule, measurements of temperatures in the hydrostatic water 
legs. Readings of the temperature indicating device, which is located 
in the steam/water interface, and the temperature recording device must 
be observed and the temperatures recorded at the time the first 
containers enter the steam dome. Thereafter, these instruments must be 
read and the temperatures recorded with sufficient frequency to ensure 
compliance with the temperature specified in the process schedule and 
should be made at least every hour of continuous retort operation. 
Container conveyor speed, and for agitating hydrostatic retorts, the 
rotative chain speed, must be determined and recorded at intervals of 
sufficient frequency to ensure compliance with the process schedule and 
should be performed at least every 4 hours.
    (b) Processing in water--(1) Batch still retorts. For each retort 
batch, record the retort number or other designation, the approximate 
number of containers or number of retort crates per retort load, 
product initial temperature, time steam on, the start of process 
timing, water level, water recirculation rate (if critical), overriding 
pressure maintained, time steam off, and actual processing time. The 
indicating temperature device and the temperature recorder must be read 
at the same time at least once during process timing and the observed 
temperatures recorded.
    (2) Batch agitating retorts. In addition to recording the 
information required in paragraph (b)(1) of this section, record the 
retort or reel speed.
    (c) Processing in steam/air mixtures. For each retort batch, record 
the retort number or other designation, the approximate number of 
containers or number of retort crates per retort load, product initial 
temperature, time steam on, venting procedure, if applicable, the start 
of process timing, maintenance of circulation of the steam/air mixture, 
air flow rate or forced recirculation flow rate (if critical), 
overriding pressure maintained, time steam off, and actual processing 
time. The indicating temperature device and the temperature recorder 
must be read at the same time at least once during process timing and 
the observed temperatures recorded.
    (d) Atmospheric cookers--(1) Batch-type systems. For each cooker 
batch, record the cooker number or other designation and the 
approximate number of containers. In addition, record all critical 
factors of the process schedule such as cooker temperature, initial 
temperature, the time the thermal process cycle begins and ends, hold 
time, and the final internal product temperature.
    (2) Continuous-type systems. Record the cooker number or other 
designation, the time the first containers enter and the last 
containers exit a cooker, and the approximate total number of 
containers processed. In addition, record all critical factors of the 
process schedule such as the initial temperature, cooker speed, and 
final internal product temperature.


Sec.  431.8   Record review and maintenance.

    (a) Process records. Charts from temperature/time recording devices 
must be identified by production date, container code, processing 
vessel number or other designation, and other data as necessary to 
enable correlation with the records required in Sec.  431.7. Each entry 
on a record must be made at the time the specific event occurs, and the 
recording individual must sign or initial each record form. No later 
than 1 working day after the actual process, the establishment must 
review all processing and production records to ensure completeness and 
to determine if all product received the process schedule. All records, 
including the temperature/time recorder charts and critical factor 
control records, must be signed or initialed and dated by the person 
conducting the review. All processing and production records required 
in this subpart must be made available to Program employees for review.
    (b) Automated process monitoring and recordkeeping. Automated 
process monitoring and recordkeeping systems must be designed and 
operated in a manner that will ensure compliance with the applicable 
requirements of Sec.  431.7.
    (c) Container closure records. Written records of all container 
closure examinations must specify the container code, the date and time 
of container closure examination, the measurement(s) obtained, and any 
corrective actions taken. Records must be signed or initialed by the 
container closure technician and must be reviewed and signed by the 
establishment within 1 working day after the actual production to 
ensure that the records are complete and that the closing operations 
have been properly controlled. All container closure examination 
records required in this subpart must be made available to Program 
employees for review.
    (d) Distribution of product. Records must be maintained by the 
establishment identifying initial distribution of the finished product 
to facilitate, if necessary, the segregation of specific production 
lots that may have

[[Page 25324]]

been contaminated or are otherwise unsound for their intended use.
    (e) Retention of records. Copies of all processing and production 
records required in Sec.  431.7 must be retained for no less than 1 
year at the establishment, and for an additional 2 years at the 
establishment or other location from which the records can be made 
available to Program employees within 3 working days.


Sec.  431.9   Deviations in processing.

    (a) Whenever the actual process is less than the process schedule 
or when any critical factor does not comply with the requirements for 
that factor as specified in the process schedule, it must be considered 
a deviation in processing.
    (b) Deviations in processing (or process deviations) must be 
handled according to:
    (1) A HACCP plan for canned product that addresses hazards 
associated with microbial contamination; or,
    (2) Alternative documented procedures that will ensure that only 
safe and stable product is shipped in commerce; or
    (3) Paragraph (c) of this section.
    (c) Procedures for handling process deviations 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) Deviations identified in-process. If a deviation is noted at 
any time before the completion of the intended process schedule, the 
establishment must:
    (i) Immediately reprocess the product using the full process 
schedule; or
    (ii) Use an appropriate alternate process schedule provided such a 
process schedule has been established in accordance with Sec.  431.3(a) 
and (b) and is filed with the inspector in accordance with Sec.  
431.3(c); or
    (iii) Hold the product involved and have the deviation evaluated by 
a processing authority to assess the safety and stability of the 
product. Upon completion of the evaluation, the establishment must 
provide the inspector the following:
    (A) A complete description of the deviation along with all 
necessary supporting documentation;
    (B) A copy of the evaluation report; and
    (C) A description of any product disposition actions, either taken 
or proposed.
    (iv) Product handled in accordance with paragraph (c)(1)(iii) of 
this section must not be shipped from the establishment until the 
Program has reviewed all of the information submitted and approved the 
product disposition actions.
    (v) If an alternate process schedule is used that is not on file 
with the inspector or if an alternate process schedule is immediately 
calculated and used, the product must be set aside for further 
evaluation in accordance with paragraphs (c)(1)(iii) and (iv) of this 
section.
    (vi) When a deviation occurs in a continuous rotary retort, the 
product must be handled in accordance with paragraphs (c)(1)(iii) and 
(iv) of this section or in accordance with the following procedures:
    (A) Emergency stops. (1) When retort jams or breakdowns occur 
during the processing operations, all containers must be given an 
emergency still process (developed per Sec.  431.3(b)) before the 
retort is cooled or the retort must be cooled promptly and all 
containers removed and either reprocessed, repacked and reprocessed, or 
destroyed. Regardless of the procedure used, containers in the retort 
intake valve and in transfer valves between retort shells at the time 
of a jam or breakdown must be removed and either reprocessed, repacked 
and reprocessed and or destroyed. Product to be destroyed must be 
handled as ``U.S. Inspected and Condemned,'' as defined in Sec.  301.2 
of this chapter, or as ``U.S. Condemned,'' as defined in Sec.  381.1(b) 
of this chapter, and disposed of in accordance with part 314 of this 
chapter or with Sec.  381.95 of this chapter, as applicable.
    (2) The time the retort reel stopped and the time the retort is 
used for an emergency still retort process must be noted on the 
temperature/time recording device and entered on the other production 
records required in Sec.  431.7.
    (B) Temperature drops. When the retort temperature drops below the 
temperature specified in the process schedule, the reel must be stopped 
and the following actions must be taken:
    (1) For temperature drops of less than 10[emsp14][deg]F (or 5.5 
[deg]C) either:
    (i) All containers in the retort must be given an emergency still 
process (developed per Sec.  431.3(b)) before the reel is restarted;
    (ii) Container entry to the retort must be prevented and an 
emergency agitating process (developed per Sec.  431.3(b)) must be used 
before container entry to the retort is restarted; or
    (iii) Container entry to the retort must be prevented and the reel 
restarted to empty the retort. The discharged containers must be 
reprocessed, repacked and reprocessed, or destroyed. Product to be 
destroyed must be handled as ``U.S. Inspected and Condemned,'' as 
defined in Sec.  301.2 of this chapter, or as ``U.S. Condemned,'' as 
defined in Sec.  381.1(b) of this chapter, and disposed of in 
accordance with part 314 of this chapter or with Sec.  381.95 of this 
chapter, as applicable.
    (2) For temperature drops of 10 [deg]F (or 5.5 [deg]C) or more, all 
containers in the retort must be given an emergency still process 
(developed per Sec.  431.3(b)). The time the reel was stopped and the 
time the retort was used for a still retort process must be marked on 
the temperature/time recording device by the establishment and entered 
on the other production records required in Sec.  431.7. Alternatively, 
container entry to the retort must be prevented and the reel restarted 
to empty the retort. The discharged containers must be either 
reprocessed, repacked and reprocessed, or destroyed. Product to be 
destroyed must be handled as ``U.S. Inspected and Condemned,'' as 
defined in Sec.  301.2 of this chapter, or as ``U.S. Condemned,'' as 
defined in Sec.  381.1(b) of this chapter, and disposed of in 
accordance with part 314 of this chapter or with Sec.  381.95 of this 
chapter, as applicable.
    (2) Deviations identified through record review. Whenever a 
deviation is noted during review of the processing and production 
records required by Sec.  431.8(a) and (b), the establishment must hold 
the product involved and the deviation must be handled in accordance 
with paragraphs (c)(1)(iii) and (iv) of this section.
    (d) Process deviation file. The establishment must maintain full 
records regarding the handling of each deviation. Such records must 
include, at a minimum, the appropriate processing and production 
records, a full description of the corrective actions taken, the 
evaluation procedures and results, and the disposition of the affected 
product. Such records must be maintained in a separate file or in a log 
that contains the appropriate information. The file or log must be 
retained in accordance with Sec.  431.8(e) and must be made available 
to Program employees upon request.


Sec.  431.10   Finished product inspection.

    (a) Finished product inspections must be handled according to:
    (1) An HACCP plan for canned product that addresses hazards 
associated with microbiological contamination;
    (2) An FSIS-approved total quality control system;

[[Page 25325]]

    (3) Alternative documented procedures that will ensure that only 
safe and stable product is shipped in commerce; or
    (4) Paragraph (b) of this section.
    (b) 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 must 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 must 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 must 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) must 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.  431.1; and
    (B) Acidified low acid products as defined in Sec.  431.1.
    (iv) Incubation samples. (A) From each load of product processed in 
a batch-type thermal processing system (still or agitation), the 
establishment must select at least one container for incubation.
    (B) For continuous rotary retorts, hydrostatic retorts, or other 
continuous-type thermal processing systems, the establishment must 
select at least one container per 1,000 for incubation.
    (C) Only normal-appearing containers must be selected for 
incubation.
    (v) Incubation time. Canned product requiring incubation must be 
incubated for not less than 10 days (240 hours) under the conditions 
specified in paragraph (b)(1)(ii) of this section.
    (vi) Incubation checks and record maintenance. Designated 
establishment employees must visually check all containers under 
incubation each working day and the inspector must 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 must record at least the product 
name, container size, container code, number of containers incubated, 
in and out dates, and incubation results. The establishment must retain 
such records, along with copies of the temperature/time recording 
charts, in accordance with Sec.  431.8(d).
    (vii) Abnormal containers. The finding of abnormal containers (as 
defined in Sec.  431.1) among incubation samples is cause to officially 
retain at least the code lot involved.
    (viii) Shipping. No product must be shipped from the establishment 
before the end of the required incubation period. An establishment 
wishing to ship product prior to the completion of the required 
incubation period must submit a written proposal to the District 
Office. Such a proposal must 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 
District Office, product may be routinely shipped provided the 
establishment continues to comply with all requirements of this 
subpart.
    (2) [Reserved]
    (c) Container condition--(1) Normal containers. Only normal-
appearing containers must be shipped from an establishment as 
determined by an appropriate sampling plan or other means acceptable to 
program employees.
    (2) Abnormal containers. When abnormal containers are detected by 
any means other than incubation, the establishment must inform the 
inspector, and the affected code lot(s) must 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.


Sec.  431.11   Personnel and training.

    All operators of thermal processing systems specified in Sec.  
431.6 and container closure technicians must be under the direct 
supervision of a person who has successfully completed a school of 
instruction that is generally recognized as adequate for properly 
training supervisors of canning operations.


Sec.  431.12   Recall procedure.

    Establishments must prepare and maintain a current procedure for 
the recall of all canned product covered by this subpart. Upon request, 
the recall procedure must be made available to Program employees for 
review.

PART 548--PREPARATION OF PRODUCTS

0
25. The authority citation for part 548 is revised to read as follows:

    Authority:  7 U.S.C. 1633; 21 U.S.C. 601-602, 606-695; 7 CFR 
2.7, 2.18, 2.53.


Sec.  548.6  [Amended]

0
26. Section 548.6 is amended by removing ``9 CFR part 318, subpart G 
(Sec. Sec.  318.300-318.311)'' and adding in its place ``9 CFR part 
431''.

    Done in Washington, DC.
Paul Kiecker,
Acting Administrator.
[FR Doc. 2018-11300 Filed 5-30-18; 8:45 am]
 BILLING CODE 3410-DM-P