
[Federal Register Volume 80, Number 183 (Tuesday, September 22, 2015)]
[Proposed Rules]
[Pages 57137-57141]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23614]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 108

[Docket No. FDA-2015-N-2819]


Emergency Permit Control Regulations; Technical Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; technical amendments.

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[[Page 57138]]

SUMMARY: The Food and Drug Administration (FDA or we) is proposing to 
amend certain regulations pertaining to registration and process 
filings related to acidified foods and thermally processed low-acid 
foods packaged in hermetically sealed containers (historically referred 
to as ``low-acid canned foods'' or ``LACF''). The amendments would 
reflect new FDA process filing form numbers and would make changes to 
addresses or locations where such forms can be found or must be sent. 
Additionally, the amendments would remove obsolete references to the 
effective dates that occurred years ago and update a reference to 
another Federal Agency.

DATES: Submit either electronic or written comments on the proposed 
rule by December 7, 2015.

ADDRESSES: You may submit comments by any of the following methods.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following way:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No. 
(FDA-2015-N-2819) for this rulemaking. All comments received may be 
posted without change to http://www.regulations.gov, including any 
personal information provided. For additional information on submitting 
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number(s), found in brackets in the heading of this document, 
into the ``Search'' box and follow the prompts and/or go to the 
Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852.

FOR FURTHER INFORMATION CONTACT: Susan Brecher, Center for Food Safety 
and Applied Nutrition (HFS-302), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1781.

SUPPLEMENTARY INFORMATION: 

I. Background

    Among other things, current FDA regulations at part 108 (21 CFR 
part 108) provide that a commercial processor, when first engaging in 
the manufacture, processing, or packing of acidified foods or low-acid 
canned foods, must, not later than 10 days after first so engaging, 
register and file with FDA information including the name of the 
establishment, principal place of business, the location of each 
establishment in which that processing is carried on, the processing 
method, and a list of foods so processed in each establishment (Sec.  
108.25(c)(1) and Sec.  108.35(c)(1)). In addition, our regulations 
require the submission of process filing forms. Specifically, our 
regulations require that commercial processors engaged in the 
processing of acidified foods must, not later than 60 days after 
registration, and before packing any new product, provide FDA with 
information on the scheduled processes for each acidified food in each 
container size (Sec.  108.25(c)(2)). An analogous requirement for 
process filing applies to commercial processors of low-acid canned 
foods (Sec.  108.35(c)(2)). The regulations specify the specific 
process filing forms to be used (Forms FDA 2541a and 2541c), and also 
state where the forms can be obtained and where the forms should be 
sent.
    We recently engaged in an effort to modernize our forms and to 
provide a means for submitting the forms using electronic ``smart 
form'' technology. This effort involved the drafting of four new draft 
process filing forms: Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 
2541g. (For more information about the draft new process filing forms, 
see ``Draft Guidance for Industry: Submitting Form FDA 2541 (Food 
Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA 
2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic 
or Paper Format,'' available at http://www.fda.gov/FoodGuidances.) Once 
completed, this effort will make it easier for firms to submit 
information to us and will improve the accuracy of the information 
submitted in the forms. In conjunction with these changes, the proposed 
rule would make technical amendments to Sec.  108.25, ``Acidified 
Foods,'' and Sec.  108.35, ``Thermal Processing of Low-Acid Foods 
Packaged in Hermetically Sealed Containers.'' Specifically, the 
proposed rule would incorporate the new FDA form numbers. FDA hopes to 
finalize the new process filing forms later in 2015. By incorporating 
the new FDA form numbers into part 108, the proposed rule would cause 
the new forms to fully replace the forms currently listed in part 108 
once this proposed rule becomes final and effective. At that point, FDA 
would no longer accept the currently-listed forms.
    In addition, the proposed rule would make changes to the addresses 
or locations where forms can be found or must be sent. Finally, the 
proposed rule would remove obsolete references to dates that occurred 
years ago and would update the name of the Agency of the U. S. 
Department of Agriculture that administers the meat and poultry 
inspection programs under the Federal Meat Inspection Act and the 
Poultry Products Inspection Act.

II. Legal Authority

    We are issuing this proposed rule under the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act). Section 404(a) of the FD&C Act (21 U.S.C. 
344(a)) provides that whenever the Secretary finds after investigation 
that the distribution in interstate commerce of any class of food may, 
by reason of contamination with micro-organisms during the manufacture, 
processing, or packing thereof in any locality, be injurious to health, 
and that such injurious nature cannot be adequately determined after 
such articles have entered interstate commerce, the Secretary then 
shall issue regulations providing for the issuance, to manufacturers, 
processors, or packers of such class of food in such locality, of 
permits to which shall be attached such conditions governing the 
manufacture, processing, or packing of such class of food, for such 
temporary period of time, as may be necessary to protect the public 
health. Under section 404 of the FD&C Act, FDA's regulations in part 
108 have long required registration of food processing establishments, 
filing of process information, and maintenance of processing and 
production records for acidified foods and low-acid canned foods. Under 
section 701(e) of the FD&C Act, any action for the issuance, amendment, 
or repeal of any regulation under section 404(a) of the FD&C Act shall 
be begun by a proposal made either by the Secretary on his own 
initiative or by petition of any interested persons, showing reasonable 
grounds therefor, filed with the Secretary.

III. Description of the Proposed Rule

    As stated in section I, the proposed rule would make technical 
amendments to Sec.  108.25, ``Acidified Foods,'' and Sec.  108.35, 
``Thermal Processing of Low-Acid Foods Packaged in Hermetically Sealed 
Containers.'' These changes would incorporate the new FDA form

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numbers and changes to the addresses or locations where forms can be 
found or must be sent. These changes would also remove obsolete 
references to dates that occurred years ago and would update the name 
of the Agency of the U. S. Department of Agriculture that administers 
the meat and poultry inspection programs under the Federal Meat 
Inspection Act and the Poultry Products Inspection Act. Specifically, 
the proposed rule would:
     Amend Sec.  108.25(c)(1) and (c)(2) and Sec.  108.35(c)(1) 
and (c)(2) to replace the obsolete mailing code (HFS-618) listed in 
those provisions with the current mailing code (HFS-303) for the FDA 
office identified in those provisions.
     Amend Sec.  108.25(c)(1) and (c)(2) and Sec.  108.35(c)(1) 
and (c)(2) to provide an Internet address where forms can be found or 
submitted. The new text would state that the forms are available on our 
Web site at http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/ucm2007436.htm and, 
for electronic submission, would refer to FDA's Industry Systems Web 
site at www.access.fda.gov.
     Amend Sec.  108.25(c)(1) by deleting ``Commercial 
processors presently so engaged shall register within 120 days after 
the effective date of this regulation.'' We propose to delete this 
sentence because the effective date occurred years ago, so the sentence 
is no longer necessary. We also propose to replace the sentence stating 
that ``Foreign processors shall register within 120 days after the 
effective date of this regulation or before any offering of foods for 
import into the United States, whichever is later,'' with a new 
sentence stating that ``Foreign processors shall register before any 
offering of foods for import into the United States.'' We propose to 
make this change because the effective date occurred years ago, so 
reference to the effective date is no longer necessary.
     Amend Sec.  108.25(c)(2) by replacing ``form FDA 2541a 
(food canning establishment process filing form for all methods except 
aseptic)'' with ``Form FDA 2541e (Food Process Filing for Acidified 
Method).'' This change would reflect the new form number and form that 
FDA is introducing.
     Amend Sec.  108.35(c)(1) by deleting the sentence stating 
that ``Commercial processors presently so engaged shall register not 
later than July 13, 1973.'' Given the passage of time since Sec.  
108.35(c)(1) was issued, reference to the date of July 13, 1973, is no 
longer necessary.
     Amend Sec.  108.35(c)(2) by replacing ``Form FDA 2541a 
(food canning establishment process filing for all methods except 
aseptic), or Form FDA 2541c (food canning establishment process filing 
for aseptic systems)'' with a list of the following new forms: Form FDA 
2541d (Food Process Filing for Low-Acid Retorted Method); Form FDA 
2541f (Food Process Filing for Water Activity/Formulation Control 
Method); and Form FDA 2541g (Food Process Filing for Low-Acid Aseptic 
Systems). These changes refer to the new form numbers and forms that 
FDA is introducing.
     Amend Sec.  108.35(c)(2)(ii) by inserting ``LACF 
Registration Coordinator (HFS-303)'' before ``Center for Food Safety 
and Applied Nutrition.'' This change would provide greater specificity 
as to the FDA office that should receive information for purposes of 
Sec.  108.35(c)(2)(ii).
     Amend Sec.  108.35(i) (which refers to ``the meat and 
poultry inspection program of the Animal and Plant Health Inspection 
Service of the Department of Agriculture'') by replacing ``Animal and 
Plant Health Inspection Service'' with ``Food Safety Inspection 
Service.'' We are making this change because the Food Safety and 
Inspection Service of the U.S. Department of Agriculture now 
administers the meat and poultry inspection program under the Federal 
Meat Inspection Act and the Poultry Products Inspection Act, and not 
the Animal and Plant Health Inspection Service.

IV. Proposed Effective Date

    We propose that any final rule resulting from this rulemaking 
process become effective 30 days after its date of publication in the 
Federal Register.

V. Economic Analysis of Impacts

    We are publishing this proposed rule under the formal rulemaking 
process. Executive Order 12866 does not require us to analyze the costs 
and benefits of proposed rules that we publish under this rulemaking 
process.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. The proposed rule would amend Sec. Sec.  108.25 and 
108.35 to delete obsolete references to long-expired effective dates, 
make changes to FDA addresses or locations, and reflect new process 
filing forms. With regard to the new process filing forms, FDA would 
replace references to Forms FDA 2541a and FDA 2541c with references to 
four new process filing forms: Forms FDA 2541d, FDA 2541e, FDA 2541f, 
and FDA 2541g. Some of the data entry fields on the four new process 
filing forms are not on current Forms FDA 2541a and FDA 2541c. The new 
forms add certain data entry fields to improve the efficiency of FDA's 
review of the process filings. For example, the new forms include data 
entry fields for the ``food product group'' (such as liquid, ready-to-
eat ``breakfast foods''). In addition, the new forms provide for 
``smart form'' technology using an electronic submission system. The 
updated process filing portion of the electronic submission system 
queries the processor about the processes used to produce the food and 
presents only those data entry fields that are applicable. As a result, 
processors will no longer need to evaluate whether particular data 
entry fields are applicable to their products. For example, when a 
processor submits a process filing for a product that is processed 
using a low-acid retorted method with a process mode of ``agitating,'' 
smart form technology would bypass questions that are not applicable to 
this process mode option. We estimate that the additional time it would 
take processors to complete the new information requested on the new 
forms would be offset by the time processors will save by not having to 
evaluate whether certain data entry fields on Form FDA 2541a or FDA 
2541c are applicable to their products. Hence, we propose to certify 
that the rule, if finalized, will not have a significant economic 
impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $144 million, using the most current (2014) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
proposed rule to result in any 1-year expenditure that would meet or 
exceed this amount.

VI. Analysis of Environmental Impact

    FDA has determined, under 21 CFR 25.30(i), that this proposed rule 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

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VII. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). These 
collections of information have been previously approved under OMB 
control number 0910-0037 which expires September 30, 2017.

VIII. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. FDA has determined that 
the proposed rule, if finalized, would not contain policies that would 
have substantial direct effects on the States, on the relationship 
between the National Government and the States, or on the distribution 
of power and responsibilities among the various levels of government. 
Accordingly, we tentatively conclude that the proposed rule does not 
contain policies that have federalism implications as defined in the 
Executive Order and, consequently, a federalism summary impact 
statement is not required.

IX. Additional Information Regarding Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

List of Subjects in 21 CFR Part 108

    Administrative practice and procedure, Foods, Reporting and 
recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 108 be amended as follows:

PART 108--EMERGENCY PERMIT CONTROL

0
1. The authority citation for 21 CFR part 108 continues to read as 
follows:

    Authority:  21 U.S.C. 342, 344, 371.

0
2. In Sec.  108.25, revise paragraphs (c)(1) and (c)(2) to read as 
follows:


Sec.  108.25  Acidified foods.

* * * * *
    (c)(1) Registration. A commercial processor, when first engaging in 
the manufacture, processing, or packing of acidified foods in any 
State, as defined in section 201(a)(1) of the act, shall, not later 
than 10 days after first so engaging, register and file with the Food 
and Drug Administration on Form FDA 2541 (food canning establishment 
registration) information including, but not limited to, the name of 
the establishment, principal place of business, the location of each 
establishment in which that processing is carried on, the processing 
method in terms of acidity and pH control, and a list of foods so 
processed in each establishment. These forms are available from the 
LACF Registration Coordinator (HFS-303), Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740, or at any Food and Drug Administration 
district office. The completed form shall be submitted to the Center 
for Food Safety and Applied Nutrition (HFS-565), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. These 
forms also are available on the Food and Drug Administration's Web site 
at http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/ucm2007436.htm. For electronic submission go 
to FDA's Industry Systems Web site at www.access.fda.gov. Foreign 
processors shall register before any offering of foods for import into 
the United States. Commercial processors duly registered under this 
section shall notify the Food and Drug Administration not later than 90 
days after the commercial processor ceases or discontinues the 
manufacture, processing, or packing of the foods in any establishment, 
except that this notification shall not be required for temporary 
cessations due to the seasonal character of an establishment's 
production or by temporary conditions including, but not limited to, 
labor disputes, fire, or acts of God.
    (2) Process filing. A commercial processor engaged in the 
processing of acidified foods shall, not later than 60 days after 
registration, and before packing any new product, provide the Food and 
Drug Administration information on the scheduled processes including, 
as necessary, conditions for heat processing and control of pH, salt, 
sugar, and preservative levels and source and date of the establishment 
of the process, for each acidified food in each container size. Filing 
of this information does not constitute approval of the information by 
the Food and Drug Administration, and information concerning processes 
and other data so filed shall be regarded as trade secrets within the 
meaning of 21 U.S.C. 331(j) and 18 U.S.C. 1905. This information shall 
be submitted on Form FDA 2541e (Food Process Filing for Acidified 
Method). Forms are available from the LACF Registration Coordinator 
(HFS-303), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or at 
Food and Drug Administration district office. The completed form shall 
be submitted to the LACF Registration Coordinator (HFS-618), Center for 
Food Safety and Applied Nutrition, Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740. These forms also are 
available on the Food and Drug Administration's Web site at http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/ucm2007436.htm. For electronic submission go 
to FDA's Industry Systems Web site at www.access.fda.gov.
* * * * *
0
3. In Sec.  108.35, revise paragraphs (c)(1), (c)(2) introductory text, 
(c)(2)(ii), and (i) to read as follows:


Sec.  108.35  Thermal processing of low-acid foods packaged in 
hermetically sealed containers.

* * * * *
    (c) * * *
    (1) Registration. A commercial processor when first engaging in the 
manufacture, processing, or packing of thermally processed low-acid 
foods in hermetically sealed containers in any state, as defined in 
section 201(a)(1) of the act, shall, not later than 10 days after first 
so engaging, register with the Food and Drug Administration on Form FDA 
2541 (food canning establishment registration) information including 
(but not limited to) his name, principal place of business, the 
location of each establishment in which such processing is carried on, 
the processing method in terms of the type of processing equipment 
employed, and a list of the low-acid foods so processed in each such 
establishment. These forms are available from the LACF Registration 
Coordinator (HFS-303), Center for Food Safety and Applied Nutrition, 
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740, or at any Food and Drug Administration district office. The 
completed form shall be submitted to the LACF Registration

[[Page 57141]]

Coordinator (HFS-618), Center for Food Safety and Applied Nutrition, 
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740. These forms also are available on the Food and Drug 
Administration's Web site at http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/AcidifiedLow-AcidCanned/Foods/default.htm. 
For electronic submission go to FDA's Industry Systems Web site at 
www.access.fda.gov. Commercial processors duly registered in accordance 
with this section shall notify the Food and Drug Administration not 
later than 90 days after such commercial processor ceases or 
discontinues the manufacture, processing, or packing of thermally 
processed foods in any establishment: Provided, That such notification 
shall not be required as to the temporary cessation necessitated by the 
seasonal character of the particular establishment's production or 
caused by temporary conditions including but not limited to strikes, 
lockouts, fire, or acts of God.
    (2) Process filing. A commercial processor engaged in the thermal 
processing of low-acid foods packaged in hermetically sealed containers 
shall, not later than 60 days after registration and prior to the 
packing of a new product, provide the Food and Drug Administration 
information as to the scheduled processes including but not limited to 
the processing method, type of retort or other thermal processing 
equipment employed, minimum initial temperatures, times and 
temperatures of processing, sterilizing value (Fo), or other equivalent 
scientific evidence of process adequacy, critical control factors 
affecting heat penetration, and source and date of the establishment of 
the process, for each such low-acid food in each container size: 
Provided, That the filing of such information does not constitute 
approval of the information by the Food and Drug Administration, and 
that information concerning processes and other data so filed shall be 
regarded as trade secrets within the meaning of 21 U.S.C. 331(j) and 18 
U.S.C. 1905. This information shall be submitted on the following forms 
as appropriate: Form FDA 2541d (Food Process Filing for Low-Acid 
Retorted Method), Form FDA 2541f (Food Process Filing for Water 
Activity/Formulation Control Method), or Form FDA 2541g (Food Process 
Filing for Low-Acid Aseptic Systems). These forms are available from 
the LACF Registration Coordinator (HFS-303), Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740, or at any Food and Drug Administration 
district office. The completed form(s) shall be submitted to the LACF 
Registration Coordinator (HFS-303), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740. These forms also are available on the Food and 
Drug Administration's Web site at http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/AcidifiedLow-AcidCannedFoods/default.htm. 
For electronic submission, go to FDA's Industry Systems Web site at 
www.access.fda.gov.
* * * * *
    (ii) If a packer intentionally makes a change in a previously filed 
scheduled process by reducing the initial temperature or retort 
temperature, reducing the time of processing, or changing the product 
formulation, the container, or any other condition basic to the 
adequacy of scheduled process, he shall prior to using such changed 
process obtain substantiation by qualified scientific authority as to 
its adequacy. Such substantiation may be obtained by telephone, 
telegram, or other media, but must be promptly recorded, verified in 
writing by the authority, and contained in the packer's files for 
review by the Food and Drug Administration. Within 30 days after first 
use, the packer shall submit to the LACF Registration Coordinator (HFS-
303), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740 a 
complete description of the modifications made and utilized, together 
with a copy of his file record showing prior substantiation by a 
qualified scientific authority as to the safety of the changed process. 
Any intentional change of a previously filed scheduled process or 
modification thereof in which the change consists solely of a higher 
initial temperature, a higher retort temperature, or a longer 
processing time, shall not be considered a change subject to this 
paragraph, but if that modification is thereafter to be regularly 
scheduled, the modified process shall be promptly filed as a scheduled 
process, accompanied by full information on the specified forms as 
provided in this paragraph.
* * * * *
    (i) This section shall not apply to the commercial processing of 
any food processed under the continuous inspection of the meat and 
poultry inspection program of the Food Safety Inspection Service of the 
Department of Agriculture under the Federal Meat Inspection Act (34 
Stat. 1256, as amended by 81 Stat. 584 (21 U.S.C. 601 et seq.)) and the 
Poultry Products Inspection Act (71 Stat. 441, as amended by 82 Stat. 
791 (21 U.S.C. 451 et seq.)).
* * * * *

    Dated: September 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-23614 Filed 9-21-15; 8:45 am]
 BILLING CODE 4164-01-P


