[Federal Register Volume 81, Number 59 (Monday, March 28, 2016)]
[Proposed Rules]
[Pages 17338-17359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-06576]



[[Page 17337]]

Vol. 81

Monday,

No. 59

March 28, 2016

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; Proposed Rule

  Federal Register / Vol. 81 , No. 59 / Monday, March 28, 2016 / 
Proposed Rules  

[[Page 17338]]


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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

[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: Supplemental proposed rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to 
amend 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. If this 
supplemental proposed rule is finalized, FSIS will end 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 proposing to consolidate the regulations on thermally 
processed, commercially sterile meat and poultry products (i.e., canned 
food products containing meat or poultry).

DATES: Comments must be received on or before May 27, 2016.

ADDRESSES: FSIS invites interested persons to submit comments on this 
rulemaking. Comments may be submitted by one of the following methods:
     Federal eRulemaking Portal: This Web site provides the 
ability to type short comments directly into the comment field on this 
Web page or attach a file for lengthier comments. Go to http://www.regulations.gov. Follow the on-line instructions at that site for 
submitting comments.
     Mail, including CD-ROMs, etc.: Send to Docket Clerk, U.S. 
Department of Agriculture, Food Safety and Inspection Service, Patriots 
Plaza 3, 1400 Independence Avenue SW., Mailstop 3782, Room 8-163A, 
Washington, DC 20250-3700.
     Hand- or courier-delivered submittals: Deliver to Patriots 
Plaza 3, 355 E. Street SW., Room 8-163A, Washington, DC 20250-3700.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2015-0036. Comments 
received in response to this docket will be made available for public 
inspection and posted without change, including any personal 
information, to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Daniel Engeljohn, 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 (spp.) 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.
    Because of the length of time since the publication of the proposed 
rule, FSIS is providing the public an opportunity to comment on this 
supplemental proposed rule. In this supplemental proposed rule, FSIS is 
only addressing the proposed changes to the regulations on control of 
trichinae in pork products and on thermally processed, commercially 
sterile meat and poultry products. FSIS is re-proposing the changes to 
remove the trichinae requirements, consistent with what FSIS originally 
proposed in 2001. In addition, rather than what it proposed in 2001, 
FSIS is proposing 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. 
These minor changes are described below in the responses to comments.
    FSIS addressed Lm 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). Therefore, FSIS has concluded 
that requiring establishments to test for Listeria spp. is unnecessary 
because post-lethality interventions and formulation of RTE meat and 
poultry products with growth inhibitors is much more effective in 
preventing listeriosis than testing product or food contact surfaces 
(see 80 FR 35178, 35184). FSIS is withdrawing that and 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.
    Based on available data, FSIS is confident that it is successfully 
carrying out its mission to protect public health by enforcing 
safeguards designed to ensure that RTE products do not become 
contaminated with pathogens of concern, including Lm and Salmonella. 
Since FSIS issued the 2001 proposed rule described above, the percent 
positive in FSIS testing for Lm in RTE products has decreased from 1.32 
percent in CY 2001 to 0.32 percent in CY 2014. The percent positive in 
FSIS testing for Salmonella in RTE products has decreased from 0.15 
percent in CY 2001 to 0.04 percent in CY 2014. The Agency considers the 
RTE regulatory results to be an excellent indicator of the trends in 
pathogen presence in RTE

[[Page 17339]]

products over several years. This downward trend shows that the current 
regulatory requirements have been effective in controlling Lm and 
Salmonella in RTE meat and poultry products.
    Pathogens adulterate RTE products, and establishments are required 
to produce RTE products that do not have detectable levels of pathogens 
(e.g., Salmonella). Also, establishments are required to stabilize RTE 
products to inhibit the growth of spore-forming bacteria (e.g., C. 
botulinum and C. perfringens). If establishments' labels indicate that 
their products are RTE by not including safe handling instructions, 
they are required to process the products to render them RTE, in 
accordance with 9 CFR 317.2(l) and 381.125(b). FSIS requires 
establishments to validate their processes to achieve at least a 6.5 
log10 reduction of Salmonella for cooked beef, roast beef, 
and cooked corned beef products (9 CFR 318.17); a 5-log10 
reduction for uncured meat patties (which establishments achieve if 
they meet the time temperature requirements in 9 CFR 318.23); a 7-
log10 reduction for cooked poultry products (9 CFR 381.150); 
or an equivalent lethality. To assist establishments in meeting these 
requirements, FSIS has issued guidance on lethality and stabilization 
in RTE products, ``Appendix A, Guidance on Relative Humidity and Time/
Temperature for Cooking/Heating and Applicability to Production of 
Other Ready-to-Eat Meat and Poultry Product Compliance Guidelines for 
Meeting Lethality Performance Standards For Certain Meat And Poultry 
Products;'' ``Appendix B, Compliance Guidelines for Cooling Heat-
Treated Meat and Poultry Products (Stabilization);'' ``Time-Temperature 
Tables for Cooking Ready-to-Eat Poultry Products;'' and ``FSIS Guidance 
on Safe Cooking of Non-Intact Meat Chops, Roasts, and Steaks.'' The 
guidance documents are available on FSIS's Web site at http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index. Although there are no specific lethality 
requirements for other fully cooked products, as noted above, they must 
be produced to eliminate any detectable pathogens. By following the 
Guidance in Appendix A and Appendix B, establishments can meet this 
requirement.
    FSIS reviews establishments' supporting documentation for their 
lethality and stabilization processes to verify that they are meeting 
regulatory requirements. FSIS is updating its guidance documents to 
ensure that industry has the necessary information to effectively 
address hazards. In addition, the Agency has finalized validation 
guidance so that establishments have information necessary to validate 
that their HACCP systems effectively address these hazards in RTE 
product. The guidance is available on FSIS's Web site at http://www.fsis.usda.gov/wps/wcm/connect/a70bb780-e1ff-4a35-9a9a-3fb40c8fe584/HACCP_Systems_Validation.pdf?MOD=AJPERES. Inspectors began verifying 
that large establishments meet all validation requirements on January 
4, 2016 and will begin verifying that small and very small 
establishments meet all validation requirements on April 4, 2016 (80 FR 
27557).

The Supplemental Proposed Rule

    Consistent with the 2001 proposed rule, this supplemental proposed 
rule will, if finalized, remove the provisions for the prescribed 
treatment of pork and pork products under 9 CFR 318.10 to provide 
establishments with the flexibility to determine whether and how they 
need to treat the products to eliminate trichinae. If this supplemental 
proposed rule is finalized, establishments will have the flexibility 
provided by the HACCP regulations (9 CFR part 417) to develop 
appropriate science-based controls for trichinae and other parasitic 
hazards in pork. All establishments producing pork products will have 
to determine whether trichinae is a hazard reasonably likely to occur 
in their processes. If it is, they must address this hazard in their 
HACCP plans or in a prerequisite program.
    Many establishments producing pork products already address 
trichinae in their HACCP plans or in a prerequisite program (see FSIS 
Notice 14-15, Prescribed Treatment to Destroy Trichinae in Pork, and 
Products Containing Pork, as Required by 9 CFR 318.10, available on 
FSIS's Web site at http://www.fsis.usda.gov/wps/wcm/connect/16732ee6-e159-4810-a423-9c31aee26c38/14-15.pdf?MOD=AJPERES&CONVERT_TO=url&CACHEID=16732ee6-e159-4810-a423-9c31aee26c38). As explained in this notice, if an establishment 
considers trichinae in its hazard analysis and determines that it is 
reasonably likely to occur, FSIS inspection program personnel (IPP) 
will verify whether the establishment is implementing any of the 
procedures in 9 CFR 318.10(c) or alternative procedures in its HACCP 
plan. If trichinae is considered and determined not to be reasonably 
likely to occur, IPP will review the decision and may question the 
adequacy of the analysis. If trichinae is not considered, IPP will 
verify whether the establishment meets the criteria in 9 CFR 318.10(c).
    If this supplemental proposed rule is finalized, all establishments 
producing pork products must assess whether trichinae is a hazard 
reasonably likely to occur. If the answer is yes, establishments must 
assess whether their products should be treated for elimination of live 
trichinae, or whether special cooking instructions are necessary on the 
label of the products. Establishments must also assess whether safe 
handling labels are sufficient to ensure that the products are cooked 
to temperatures necessary to eliminate any possible live trichinae. 
Establishments may decide to treat their products for trichinae or to 
include special cooking instructions on labels based on how consumers 
typically prepare the products or the likelihood of the products being 
confused with RTE products. Their decisions may also be based on 
whether their suppliers participate in the U.S. Trichinae Certification 
Program, which is a voluntary pre-harvest pork safety program 
administered by the Animal and Plant Health Inspection Service (APHIS) 
(see 9 CFR part 149).
    According to the Centers for Disease Control and Prevention, the 
risk for Trichinella infection associated with commercial pork has 
decreased substantially in the United States since the 1940s, when data 
collection on trichinellosis cases first began. During the period from 
2008 to 2012, only 10 cases of trichinellosis were linked to commercial 
pork products.\1\ FSIS is aware that the risk of infection with 
Trichinella is increased in organic, pasture raised swine and feral 
swine that have access to rodents and wildlife infected with 
Trichinella.\2\ FSIS has developed a draft compliance guide for 
establishments to follow should this supplemental proposed rule become 
final. The draft compliance guide is designed to help establishments, 
particularly small and very small establishments, in understanding the 
controls that are effective for the prevention and elimination of 
trichinae and other parasites in RTE and NRTE pork products. FSIS has 
posted this

[[Page 17340]]

draft compliance guide on its Web page (http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index) and 
is requesting comments on the guidance.
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    \1\ Wilson, Nana O., Hall, Rebecca L., Montgomery, Susan P., et 
al. Trichinellosis Surveillance--United States, 2008-2012. MMWR 
Surveill Summ 2014;64(No. SS-1): 1.
    \2\ Wilson, Nana O., Hall, Rebecca L., Montgomery, Susan P., et 
al. Trichinellosis Surveillance--United States, 2008-2012. MMWR 
Surveill Summ 2014;64(No. SS-1): 6.
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    In July 2015, the Codex Alimentarius Commission (Codex) adopted 
risk-based guidelines for the control of Trichinella spp. parasites in 
pork.\3\ In addition, FSIS is aware that the National Pork Producers 
Council and the National Pork Board have been supportive of efforts to 
establish a U.S. compartment of negligible risk for Trichinella in 
accordance with the World Organization for Animal Health (OIE) \4\ 
guideline. FSIS's draft compliance guide is consistent with the Codex 
and OIE guidelines.
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    \3\ Guidelines for the Control of Trichinella Spp. in Meat of 
Suidae (2015). Retrieved from http://www.codexalimentarius.org/download/standards/13896/CXG_086e_2015.pdf.
    \4\ World Organisation for Animal Health Terrestrial Animal 
Health Code. Retrieved from http://www.oie.int/fileadmin/Home/eng/Health_standards/tahc/2010/chapitre_trichinella_spp.pdf.
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    If this supplemental proposed rule is finalized, FSIS will end its 
Trichinella Approved Laboratory Program (TALP program). Since the 
1980s, FSIS has operated the 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 
(see 9 CFR 318.10(e)). There is only one laboratory enrolled in the 
TALP program. FSIS is proposing to end this program to make more 
efficient use of its resources. If this supplemental proposed rule is 
finalized, establishments may test product samples for the presence of 
trichinae using a validated testing method that is equivalent to the 
pooled sample digestion technique, or they may use another effective 
test method to verify that their system is working.
    Consistent with the 2001 proposed rule, FSIS also is proposing to 
remove the following referential and related provisions concerning 
required treatment to eliminate trichinae: The reference to the 
required trichinae treatment in 9 CFR 303.1(f); the requirement under 9 
CFR 319.106(b) that country ham products and dry cured pork shoulder be 
treated for the destruction of possible trichinae; the requirement 
under 9 CFR 319.145(a)(2) that when pork muscle tissue is combined with 
beef or veal, or both, in the preparation of certain Italian sausage 
products, it be treated for the destruction of possible live trichinae; 
the record retention requirement under 9 CFR 320.1(b)(7) concerning 
sample results and calculation results as required by processing 
procedures in 9 CFR 318.10(c)(3)(iv) (Methods 5 and 6) to destroy 
trichinae; the provision in 9 CFR 325.7(a) for including pork that has 
been refrigerated to destroy trichinae in the category of products that 
require special supervision between official establishments under 
official seal; the provision in 9 CFR 331.5(a)(1)(ii) that any meat or 
meat food product is adulterated if it is a RTE pork product that has 
not been treated to destroy trichinae as prescribed in 9 CFR 318.10; 
and the requirement under 9 CFR 424.21(a)(3)(ii) and (iii) that when 
pork muscle tissue is combined with poultry products, it must be 
treated for the destruction of possible live trichinae.

Thermally Processed, Commercially Sterile Products

    FSIS is not proposing to finalize the proposed performance standard 
for thermally processed, commercially sterile products. As discussed 
below, commenters opposed FSIS's changes, and based on its review of 
the comments, FSIS has concluded that the proposed changes are 
unnecessary. Rather, FSIS is proposing to combine the regulations for 
thermally processed, commercially sterile products in 9 CFR 381.300 
through 381.311 and 318.300 through 318.311 and recodify them into one 
new 9 CFR part 431. These regulations have been effective in ensuring 
production of safe unadulterated product. Between 2001 and 2014, there 
were only 11 recalls of thermally processed, commercially sterile 
products. Of the 11 recalls, one recall was for products that were 
contaminated with C. botulinum; one recall was for products that were 
contaminated with foreign material; three recalls were for products 
that were underprocessed; and six recalls were for products that were 
mislabeled and contained an ingredient of public health concern.
    In 9 CFR 318.301(f)(2) and 381.301(f)(2), which address containers 
and closures (proposed 9 CFR 431.2(f)(2)), FSIS is proposing to remove 
the requirement that an establishment obtain the Administrator's 
approval before using an alternative time lapse between container 
closure and the initiation of the thermal process. Under this 
supplemental proposed rule, the maximum time lapse between closing and 
initiation of thermal processing would be two hours unless data are 
available from the establishment's processing authority demonstrating 
that an alternate time period is safe and will not result in product 
spoilage.
    FSIS is proposing to remove 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) in 9 
CFR 318.305 and 381.305 (proposed 9 CFR 431.6) and to replace them with 
a single paragraph (b)(1) that describes equipment common to all the 
systems.
    In the same sections, paragraph (h)(2), FSIS is proposing to remove 
the requirement for Agency prior approval of the chemicals used by the 
establishment because the Agency no longer approves these chemicals.
    In 9 CFR 318.309 and 381.309 on finished product inspection 
(proposed 9 CFR 431.10), FSIS is proposing to redesignate paragraphs 
and to remove reserved paragraphs (b) and (c) in order to make the 
section easier to understand.
    FSIS also is proposing to replace every mention of ``area 
supervisor'' with ``District Office'' to reflect FSIS's current 
organization. Additionally, in accordance with Executive Orders 12866 
and 12988, which emphasize the need for plain language, FSIS is 
proposing to replace the word ``shall'' with ``must'' to simplify the 
effect of the regulations and make them easier to understand.
    Official establishments that produce thermally processed, 
commercially sterile meat and poultry products are reminded that they 
are subject to the HACCP regulations in 9 CFR part 417 and are required 
to conduct a hazard analysis for all such products. However, the HACCP 
regulations at 9 CFR 417.2(b)(3) exempt these establishments from 
having to address food safety hazards associated with microbiological 
contamination if the establishments comply with the canning regulations 
in 9 CFR 318.300 through 318.311 and 381.300 through 381.311 (which 
FSIS is proposing to consolidate in a new 9 CFR part 431). The canning 
regulations are based on HACCP principles, and there are obvious 
parallels between them and the HACCP regulations in approach to 
controlling food safety hazards.
    However, because the regulations in proposed 9 CFR part 431 
primarily address microbial hazards, processors of thermally processed, 
commercially sterile meat and poultry products in hermetically sealed 
containers must carry out hazard analyses and develop and implement 
HACCP plans to address any chemical or physical hazards that are 
reasonably likely to occur. The proposed regulations in 9 CFR part 431, 
and the establishment's associated process documentation, would then 
serve a function similar to that of a prerequisite program. The 
documentation would be required to be kept under 9 CFR 417.5(a)(1) as

[[Page 17341]]

documentation supporting a determination that the food safety hazards 
associated with microbiological contamination are not reasonably likely 
to occur in its operations (see FSIS Directive 7530.2, Verification 
Activities in Canning Operations that Choose to Follow the Canning 
Regulations, available on FSIS's Web site at http://www.fsis.usda.gov/wps/wcm/connect/49aeef48-21b9-4e46-ad02-269ff11183e5/7530_2.pdf?MOD=AJPERES).

Comments on the 2001 Proposed Rule and FSIS Response

    FSIS received approximately 13 comments on the proposed removal of 
the trichinae control regulations and the amendment of the thermal 
processing regulations from trade associations representing meat and 
poultry processors, companies that produce meat and poultry products, a 
company that manufactures packaging for liquid food products, and a 
farmer-owned cooperative. Following are summaries and responses to the 
comments.

Trichinae Control

    Comment: Many comments from trade associations representing meat 
and poultry processors, companies that produce meat and poultry 
products, and the farmer-owned cooperative supported the proposal to 
eliminate the prescriptive trichinae control regulations. Other 
comments from companies that produce meat and poultry products 
recommended retaining the regulations. One comment from a company that 
produces meat and poultry products asked what effect elimination of the 
trichinae control regulations would have on Toxoplasma (T.) gondii, a 
protozoan parasite that can cause the disease toxoplasmosis, in pork. 
Another comment from a company that produces meat and poultry products 
stated that safe handling labeling would not adequately inform all 
consumers that raw pork product needs to be cooked thoroughly. For 
example, the commenter stated that some raw products may have a 
``cooked'' appearance because they contain ingredients such as wine, 
paprika, or curing agents. Also, the commenter stated that consumers 
who do not know English would have difficulty relying on a safe-
handling label.
    Another comment from a company that produces meat and poultry 
products said that the requirements for destruction of trichinae should 
be retained, but that the requirements should be reevaluated as on-farm 
practices improve. This commenter suggested that the Agency provide an 
option for processors to be able to use pork from suppliers with 
control programs that ensure trichinae-free pork.
    Response: FSIS is proposing to eliminate the trichinae control 
regulations, as it proposed in 2001, largely because of their 
inconsistency with HACCP. Compliance with the HACCP regulations for RTE 
and NRTE products will ensure that trichinae and other parasites, 
including T. gondii, are eliminated. Because both trichinae and T. 
gondii have a high sensitivity to heat compared with other pathogens 
(e.g., Salmonella), the organisms would be rendered non-infective if 
pork were cooked at the times and temperatures recommended for removing 
bacterial hazards. Therefore, even if the prevalence of T. gondii were 
to increase in pork and pork products, the likelihood that T. gondii 
can survive cooking and cause foodborne illness is negligible.
    In 2007, EcoSure, an independent food safety audit company, 
conducted a consumer cooking temperature audit that involved the 
collection of data from primary shoppers of over 900 households 
geographically dispersed across the country.\5\ Participants were asked 
to record the final cooking temperature and name the main ingredient of 
any meal they prepared during the week of the study. Current cooking 
practices as captured in the 2007 EcoSure dataset show that 
approximately 76 percent of consumers are cooking pork products at the 
times and temperatures recommended for removing bacterial hazards.\6\ 
However, the 2007 EcoSure dataset does not specifically include the 
time from when the final cooking temperature was recorded to when 
consumption occurred. It is likely that product in this dataset 
encountered a range of dwell times.
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    \5\ EcoSure-EcoLab. (2007). EcoSure 2007 Cold Temperature 
Database. FoodRisk.org. available at: http://foodrisk.org/exclusives/EcoSure/.
    \6\ EcoSure-EcoLab. (2007). EcoSure 2007 Cold Temperature 
Database. FoodRisk.org. available at: http://foodrisk.org/exclusives/EcoSure/.
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    FSIS recommends in its guidance concerning whole cuts of pork a 
cooking temperature of 145 [deg]F. with 3 minutes dwell time for 
cooking whole cuts of pork. Available data support that this time/
temperature combination would be equivalent to cooking at 160 [deg]F. 
without holding a product at that temperature for any dwell time. 
FSIS's guidance concerning cooking whole cuts of pork is located at 
http://blogs.usda.gov/2011/05/25/cooking-meat-check-the-new-recommended-temperatures/.
    FSIS's guidance reflects the same standards that the Agency uses 
for cooked meat products produced in federally inspected meat 
establishments. These standards rely on the rest time of three minutes 
to achieve a safe product. Therefore, FSIS believes that safe handling 
statements are adequate to inform consumers about the time/temperature 
sufficient to ensure the product is fully cooked.
    Additionally, FSIS requires that safe handling instructions be 
prominently and conspicuously placed on labels so that intended users 
are fully aware that raw products, including raw products that may have 
a ``cooked'' appearance, must be cooked for safety (9 CFR 317.2(b)). 
The low rates of trichinellosis cases in recent years further 
demonstrate that safe handling statements are adequate to protect 
consumers from trichinae.
    As for the comment that consumers who do not know English would 
have difficulty relying on a safe-handling label, FSIS does not require 
products that are intended for domestic distribution to be labeled in 
languages other than English. However, the safe handling instructions 
are also accompanied by graphic symbols. The graphic symbols are 
intended to be visual reminders to all people reading the instructions 
and to convey messages to people who have difficulty reading English 
(59 FR 14539). Therefore, the graphics convey the necessary information 
to consumers who do not read English. The low incidence of illness also 
supports this conclusion.
    With respect to the comment that the requirements for destruction 
of trichinae should be retained until on-farm practices improve, FSIS 
has entered into an agreement with APHIS, the National Pork Producers 
Council, and two pork processors to pilot test a trichinae 
certification program to identify risk factors for trichinae infection 
and to certify production units that voluntarily adopted practices that 
reduce or eliminate the risk of trichinae. This program was finalized 
by APHIS in 2008 (73 FR 60464, October 10, 2008) and has encouraged the 
trend, referred to by the commenter, toward sound on-farm management 
practices to reduce trichinae risk. In the last 10-15 years, the swine 
industry has improved its biosecurity practices which not only reduce 
disease spread but also address risk factors for Trichinella such as 
rodent control, rapid removal of dead animals, minimizing feed exposure 
to rodents, and keeping animal feed and housing areas free of materials 
that

[[Page 17342]]

could harbor rodents.7 8 Industry led initiatives like the 
PQA Plus certification program (http://www.pork.org/pqa-plus-certification/) and the Common Industry Audit (soon to include review 
of Trichinella risk factors; http://www.pork.org/common-industry-audit/
) also support the practices described above. Because on-farm practices 
have improved, and the prevalence of Trichinella in U.S. swine is 
extremely low,\9\ FSIS is not proposing to retain the trichinae 
regulations.
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    \7\ United States Department of Agriculture, Animal and Plant 
Health Inspection Service. (2008). National Animal Health Monitoring 
System Swine 2006, Part IV: Changes in the U.S. Pork Industry, 1990-
2006. Retrieved from https://www.aphis.usda.gov/animal_health/nahms/swine/downloads/swine2006/Swine2006_dr_PartIV.pdf.
    \8\ United States Department of Agriculture, Animal and Plant 
Health Inspection Service. (2015). National Animal Health Monitoring 
System Swine 2012, Part 1: Baseline Reference of Swine Health and 
Management in the United States, 2012. Retrieved from https://www.aphis.usda.gov/animal_health/nahms/swine/downloads/swine2012/Swine2012_dr_PartI.pdf.
    \9\ Seroprevalence of Trichinella and Toxoplasma in U.S. Grower/
Finisher Pigs, 2006. (2011). Retrieved from https://www.aphis.usda.gov/animal_health/nahms/swine/downloads/swine2006/Swine2006_is_trich.pdf.
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    Regarding the suggestion that the Agency keep the current 
regulations but add an option for processors who obtain pork from 
suppliers with trichinae-control programs, processors who determine 
that trichinae is a hazard reasonably likely to occur in their products 
already have available to them this option for controlling the hazard 
(see FSIS Notice 14-15 available at http://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/fsis-notices).

Thermally Processed, Commercially Sterile Products

    Comment: Seven comments from trade associations and companies that 
produce meat and poultry products opposed the Agency's proposed 
performance standard for thermally processed, commercially sterile 
products. One commenter asserted that the existing regulations had 
worked for many years, and that there was no reason to change them. One 
comment from a trade association stated that the cost to industry to 
revalidate processes for compliance with the proposed performance 
standard would be excessive and would run into the millions of dollars. 
Another stated that, while experienced processing firms would continue 
to produce safe product under the proposed performance standard, new, 
inexperienced firms would inevitably fail and endanger public health.
    One commenter stated that the proposed performance standard would 
introduce an inconsistency with FDA regulations (21 CFR part 113), with 
which some establishments under FSIS jurisdiction and inspection also 
must comply. Another stated that the proposed standard would create 
regulatory disharmonies with the recommended code of practice of the 
Codex Alimentarius Commission.\10\ The commenters argued that FSIS 
should not change the current regulations because they are essentially 
the same as FDA's regulations and Codex's recommended code of practice.
---------------------------------------------------------------------------

    \10\ Codex Alimentarius Commission. 1979. Recommended 
International Code of Hygienic Practice for Low-Acid and Acidified 
Low-Acid Canned Foods (CAC/RCP 23-1979).
---------------------------------------------------------------------------

    A commenter from a trade association stated that rather than 
promulgating a performance standard, the Agency should consider 
combining and recodifying the currently separate requirements for meat 
and poultry products.
    The same commenter requested that FSIS eliminate the following 
requirements because the commenter argued that they do not involve food 
safety: Examination and cleaning of empty containers (9 CFR 318.301(a); 
381.301(a)) and the handling of containers after closure (9 CFR 
318.301(f)(1); 381.301(f)(1)) because the practices are not relevant to 
container integrity; equipment maintenance (9 CFR 318.305(g); 
381.305(g)) because these practices are more appropriate for a 
prerequisite program; and incubation of canned products (9 CFR 
318.309(d)(1) and (2); 381.309(d)(1) and (2)) because it is a form of 
end-product testing that is ineffective as a routine means for ensuring 
the safety of canned products.
    Additionally, the commenter requested that FSIS eliminate the 
remaining prior approval requirements that may have been overlooked 
when the Agency previously removed most of its prior approval 
requirements.
    Finally, the commenter suggested that FSIS consolidate redundant 
requirements in the sections on equipment and procedures for heat 
processing systems (9 CFR 318.305(b); 381.305(b)) because a number of 
requirements are common to two or more of the retort systems.
    Response: The Agency agrees that it should keep its regulations 
consistent with FDA's regulations and with Codex's code of practice in 
order to minimize confusion for processors. Additionally, the Agency's 
existing regulations are effective at ensuring food safety as evidenced 
by the fact that, as explained above, there have been minimal food 
product recalls involving thermally processed, commercially sterile 
products since the proposed rule published in 2001. FSIS has found no 
reason to believe that it underestimated the cost of the proposed rule; 
however, because the current regulations are effective, the Agency 
agrees with the commenters that the additional requirements in the 
proposed rule are unnecessary.
    Therefore, the Agency is proposing that the requirements for 
thermally processed, commercially sterile meat and poultry products be 
consolidated in a single part of the regulations (9 CFR part 431) and 
to make minor changes that improve the clarity of the regulations and 
remove redundant sections. As is discussed above, FSIS is proposing to 
remove the Administrator's prior approval requirement 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 proposing to replace 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). 
Combining the regulations will eliminate any confusion for processors 
of both meat and poultry products and inspection personnel over minor 
wording differences between the two sets of regulations by combining 
and recodifying the separate requirements into a single section.
    FSIS is not proposing changes to the requirements for the cleaning 
of empty containers (9 CFR 318.301(a); 381.301(a)) or to the handling 
of containers after closure (9 CFR 318.301(f)(1); 381.301(f)(1)), as 
recommended by the commenter, because these are food safety 
requirements. The regulations were implemented to ensure the canned 
product is commercially sterile. To be and remain commercially sterile, 
the container must be hermetically sealed and receive a heat process 
that renders the container free of microorganisms capable of growth at 
non-refrigerated temperatures. Container integrity has a direct impact 
on whether the container is commercially sterile. If a container, lid, 
or cover is damaged upon receipt or before filling, then it is likely 
that it will not remain hermetically sealed, and that the product will 
not remain commercially sterile. FSIS also is not proposing the changes 
to the equipment maintenance requirements that the commenter 
recommended (9 CFR 318.305; 381.305) because these are food

[[Page 17343]]

safety requirements as well, and in FSIS's experience, the majority of 
recalls for under processing are the result of human error and 
equipment failure, which includes poor maintenance. For example, in the 
one recall mentioned above for products contaminated with C. botulinum, 
FSIS found problems with equipment maintenance at the establishment 
that produced products contaminated with C. botulinum.
    FSIS is not making the changes to the incubation requirements that 
the commenter recommended (9 CFR 318.309, 381.309) because they help 
prevent cans with evidence of spoilage from entering commerce.
    However, consistent with the commenter's recommendation, FSIS is 
proposing to remove the requirement that the Administrator approve an 
establishment's use of an alternative time lapse between container 
closure and the initiation of the thermal process before the 
establishment may use the alternative (9 CFR 318.301(f)(2); 
381.301(f)(2)). This proposal will allow for more flexibility. 
Therefore, under the proposed change, the maximum time lapse between 
closing and initiation of thermal processing would be two hours unless 
data are available from the establishment's processing authority 
demonstrating that an alternate time period is safe and will not result 
in product spoilage.
    Also, consistent with what the commenter recommended, FSIS is 
proposing to remove the requirement for Agency prior approval of 
chemicals used by the establishment because the Agency no longer 
approves these chemicals. However, FSIS is not proposing to make any 
other changes to the prior approval requirements. FSIS already allows 
establishments to develop an alternate document procedure for handling 
process deviations if they do not want to hold product pending Agency 
review. FSIS has provided sufficient flexibility in the regulations, 
and the other prior approval requirements are still necessary to ensure 
food safety.
    Finally, consistent with what the commenter recommended, FSIS is 
proposing to replace 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) (9 CFR 
318.305; 381.305) with a single paragraph that describes equipment 
common to all the systems (proposed 9 CFR 431.6).

Executive Order 12866

    This supplemental proposed rule has been designated as a ``non-
significant'' regulatory action under section 3(f) of Executive Order 
(E.O.) 12866. Accordingly, the proposed rule has not been reviewed by 
the Office of Management and Budget under E.O. 12866.

Economic Impact Analysis

    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 is unlikely to 
impose additional costs on the industry because the establishments can 
address trichinae in their existing HACCP plans. If an establishment 
has identified trichinae as a hazard reasonably likely to occur, the 
establishment would have to ensure that the process it uses effectively 
eliminates the hazard under HACCP. Under FSIS Notice 14-15, Prescribed 
Treatment to Destroy Trichinae in Pork, and Products Containing Pork, 
as Required by 9 CFR 318.10, establishments can use alternative 
procedures to those prescribed in the regulations, as long as 
establishments address the hazard in their HACCP plans. Establishments 
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 (FSIS Notice 14-15).
    FSIS inspection program personnel verify that establishments 
effectively address these hazards. Under the supplemental proposed 
rule, FSIS will end TALP, saving the Agency an average of $13,750 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 proposing to eliminate 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 proposing to combine the regulations for 
thermally processed, commercially sterile meat and poultry products 
into one new 9 CFR part 431 and to make minor changes to improve 
clarity and remove redundant requirements. As is discussed above, FSIS 
is proposing to remove the Administrator's prior approval requirement 
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 proposing to replace 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 proposing 
any new requirements for canning establishments and is providing 
additional flexibility by removing prior approval provisions.

Regulatory Flexibility Act Assessment

    The FSIS Administrator has made a preliminary determination that 
this supplemental proposed rule would not have a significant economic 
impact on a substantial number of small entities in the United States, 
as defined by the Regulatory Flexibility Act (5 U.S.C. 601 et seq.).
    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 supplemental proposed 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

[[Page 17344]]

with this proposed 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, Civil Justice Reform

    This proposed 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 proposed rule will be 
preempted; (2) no retroactive effect will be given to this proposed 
rule; and (3) no administrative proceedings will be required before 
parties may file suit in court challenging this proposed rule.

Executive Order 13175

    This proposed 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 proposed 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 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.

    For the reasons set forth in the preamble, FSIS proposes to amend 
title 9, chapter III, of the Code of Federal Regulations as follows:

PART 301--DEFINITIONS

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

    Authority:  7 U.S.C. 450, 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 by removing the last sentence in the

[[Page 17345]]

definition of ``Process authority'' and the last sentence in the 
definition of ``Process schedule'' and adding in their places the 
sentence ``This definition does not apply to 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. Paragraph Sec.  303.1(f) is amended by removing the second sentence.

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

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

    Authority:  7 U.S.C. 450, 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.


Sec.  318.17  [Removed and reserved]

0
7. Section 318.17 is removed and reserved.


Sec.  318.23  [Removed and reserved]

0
8. Section 318.23 is removed and reserved.

Subpart G [Removed and reserved]

0
9. 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
10. The authority citation for part 319 continues to read as follows:

    Authority:  7 U.S.C. 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR 
2.18, 2.53.


Sec.  319.106  [Amended]

0
11. In Sec.  319.106, paragraph (b) is removed; paragraphs (c)(5) and 
(6) are removed and reserved; paragraphs (c) and (d) are redesignated 
as paragraphs (b) and (c), respectively; and the Effective Date Note is 
removed.


Sec.  319.145  [Amended]

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

PART 320--RECORDS, REGISTRATION, AND REPORTS

0
13. 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
14. In Sec.  320.1, paragraph (b)(6) is revised; paragraph (b)(7) is 
removed; paragraphs (b)(8) through (11) are redesignated as paragraphs 
(b)(7) through (10), respectively.
    The revision reads 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
15. The authority citation for part 325 is revised to read as follows:

    Authority:  7 U.S.C. 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR 
2.18, 2.53.


Sec.  325.7  [Amended]

0
16. 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
17. 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.


Sec.  331.5  [Amended]

0
18. 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
19. The authority citation for part 381 is revised to read as follows:

    Authority:  7 U.S.C. 450, 1901-1906; 21 U.S.C. 451-472; 7 CFR 
2.18, 2.53.

0
20. 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
21. 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
22. The authority citation for part 417 is revised to read as follows:

    Authority:  7 U.S.C. 450, 1901-1906; 21 U.S.C. 451-472, 601-695; 
7 CFR 2.18, 2.53.

0
23. Paragraph 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
24. The authority citation for part 424 is revised to read as follows:

    Authority:  7 U.S.C. 450, 1901-1906; 21 U.S.C. 451-472, 601-695; 
7 CFR 2.18, 2.53.


Sec.  424.21  [Amended]

0
25. In Sec.  424.21, paragraphs (a)(3)(ii) and (iii) are removed and 
paragraph (a)(3)(i) is redesignated as (a)(3).
0
26. 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. 450, 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.

[[Page 17346]]

    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, 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 [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

[[Page 17347]]

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) 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.

[[Page 17348]]

[GRAPHIC] [TIFF OMITTED] TP28MR16.041

    (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

[[Page 17349]]

observations recorded 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).
    (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) 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. Chain or conveyor speed.

[[Page 17350]]

    (d) Steam/air retorts. (1) Steam/air ratio; and
    (2) Heating medium flow rate.


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 [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 [deg]F/inch (or 12 [deg]C/cm.) within a range of 20 [deg]F (or 
11 [deg]C) of the process temperature. Chart graduations must not 
exceed 2 [deg]F degrees (or 1 [deg]C) within a range of 10 [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

[[Page 17351]]

hydrostats. (i) The basic requirements and recommendations 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 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

[[Page 17352]]

the removal of air and condensate. This information must be maintained 
on file 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.
[GRAPHIC] [TIFF OMITTED] TP28MR16.042

    Specifications (Figure 1): One, 1-inch (2.5 cm) vent for every 5 
feet (1.5 m) of retort length, equipped with a gate, plug cock, or 
other full-flow valve and discharging to atmosphere. The end vents must 
not be more than 2 1/2 feet (or 75 cm) from ends of retort.
    Venting method (Figure 1): Vent valves must be wide open for at 
least 5 minutes and to at least 225[deg] F (or 107 [deg]C), or at least 
7 minutes and to at least 220 [deg]F (or 104.5 [deg]C).
    (ii) Venting through multiple 1 inch (2.5 cm) vents discharging 
through a manifold to the atmosphere.
[GRAPHIC] [TIFF OMITTED] TP28MR16.043


    Specifications (Figure 2): One, 1-inch (2.5 cm) vent for every 5 
feet (1.5 m) of retort length; vents not over 2\1/2\ feet (or 75 cm) 
from ends of retort; size of manifold for retorts less than 15 feet 
(4.6 m) in length, 2\1/2\ inches (6.4 cm), and for retorts 15 feet (4.6 
m) and over in length, 3 inches (7.6 cm).
    Venting method (Figure 2): The manifold vent gate, plug cock, or 
other full-flow valve must be wide open for at least 6 minutes and to 
at least 225 [deg]F (or 107 [deg]C) or for at least 8 minutes and to at 
least 220 [deg]F (or 104.5 [deg]C).
    (iii) Venting through water spreaders.
    [GRAPHIC] [TIFF OMITTED] TP28MR16.044
    
    Specifications (Figure 3): Size of vent and vent valve. For retorts 
less than 15 feet (4.6 m) in length, 2 inches (or 5 cm); for retorts 15 
feet (4.6 m) and over in length, 2\1/2\ inches (6.4 cm).
    Size of water spreader (Figure 3): For retorts less than 15 feet 
(4.6 m) in length, 1\1/2\ inches (3.8 cm); for retorts 15 feet (4.6 m) 
and over in length, 2 inches (or 5 cm). The number of holes must be 
such that their total cross-sectional area is equal to the cross-
sectional area of the vent pipe inlet.
    Venting method (Figure 3): The gate, plug cock, or other full-flow 
valve on the water spreader vent must be wide open for at least 5 
minutes and to at least 225 [deg]F (or 107 [deg]C), or for at least 7 
minutes and to at least 220 [deg]F (or 104.5 [deg]C).
    (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.
[GRAPHIC] [TIFF OMITTED] TP28MR16.045

    Specifications (Figure 4): A 2\1/2\ inch (6.4 cm) vent equipped 
with a 2\1/2\ inch (6.4 cm) gate, plug cock, or other full-flow valve 
and located within 2 feet (61 cm) of the center of the retort.
    Venting method (Figure 4): The vent valve must be wide open for at 
least 4 minutes and to at least 220 [deg]F (or 104.5 [deg]C).
    (2) Venting vertical retorts. (i) Venting through a 1\1/2\ inch 
(3.8 cm) overflow.
[GRAPHIC] [TIFF OMITTED] TP28MR16.046

    Specifications (Figure 5): A 1\1/2\ inch (3.8 cm) overflow pipe 
equipped with a 1\1/2\ inch (3.8 cm) gate, plug cock, or other full-
flow valve and with not more than 6 feet (1.8 m) of 1\1/2\ inch (3.8 
cm) pipe beyond the valve before a break to the atmosphere or to a 
manifold header.
    Venting method (Figure 5): The vent valve must be wide open for at 
least 4 minutes and to at least 218 [deg]F (or 103.5 [deg]C), or for at 
least 5 minutes and to at least 215 [deg]F (or 101.5 [deg]C).
    (ii) Venting through a single 1 inch (2.5 cm) side or top vent.

[[Page 17353]]

[GRAPHIC] [TIFF OMITTED] TP28MR16.047

    Specifications (Figure 6 or 7): A 1 inch (2.5 cm) vent in lid or 
top side, equipped with a gate, plug cock, or other full-flow valve and 
discharging directly into the atmosphere or to a manifold header.
    Venting method (Figure 6 or 7): The vent valve must be wide open 
for at least 5 minutes and to at least 230 [deg]F (110 [deg]C), or for 
at least 7 minutes and to at least 220 [deg]F (or 104.5 [deg]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.
    (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

[[Page 17354]]

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) 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) 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) 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) 
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

[[Page 17355]]

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.
    (xi) 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) 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 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.
    (viii) 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) 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

[[Page 17356]]

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.


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

[[Page 17357]]

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 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

[[Page 17358]]

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 paragraph (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[emsp14][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 paragraph (c)(1)(iii) 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.

    Finished product inspections must be handled according to:
    (a) An HACCP plan for canned product that addresses hazards 
associated with microbiological contamination;
    (b) An FSIS-approved total quality control system;
    (c) Alternative documented procedures that will ensure that only 
safe and stable product is shipped in commerce; or
    (d) Procedures for handling finished product inspections where the 
HACCP plan for thermally processed/commercially sterile product does 
not address food safety hazards associated with microbial 
contamination, where there is no approved total quality control system, 
or where the establishment has no alternative documented procedures for 
handling process deviations.
    (1) Incubation of shelf stable canned product--(i) Incubator. The 
establishment 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[emsp14][deg]F (352.8 [deg]C). 
If the incubation temperature falls below 90[emsp14][deg]F (or 32 
[deg]C) or exceeds 100[emsp14][deg]F (or 38 [deg]C) but does not reach 
103[emsp14][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[emsp14][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)

[[Page 17359]]

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) Container condition--(i) 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.
    (ii) 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.

    Done in Washington, DC, on March 16, 2016.
Alfred V. Almanza,
Acting Administrator.
[FR Doc. 2016-06576 Filed 3-25-16; 8:45 am]
 BILLING CODE 3410-DM-P