
[Federal Register Volume 81, Number 138 (Tuesday, July 19, 2016)]
[Rules and Regulations]
[Pages 46828-46832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16968]


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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: Final rule; technical amendments.

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SUMMARY: The Food and Drug Administration (FDA or we) is amending 
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 reflect new FDA 
process filing form numbers, make changes to addresses or locations 
where such forms can be found or must be sent, remove obsolete 
references to the effective dates that occurred years ago, and update a 
reference to another Federal Agency.

DATES: This rule is effective August 18, 2016. See section VI for 
further information on the filing of objections. Submit either 
electronic or written objections and requests for a hearing by August 
18, 2016.

ADDRESSES: You may submit objections and requests for a hearing as 
follows:

Electronic Submissions

    Submit electronic objections in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the

[[Page 46829]]

instructions for submitting comments. Objections submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your objection will be 
made public, you are solely responsible for ensuring that your 
objection does not include any confidential information that you or a 
third party may not wish to be posted, such as medical information, 
your or anyone else's Social Security number, or confidential business 
information, such as a manufacturing process. Please note that if you 
include your name, contact information, or other information that 
identifies you in the body of your objection, that information will be 
posted on http://www.regulations.gov.
     If you want to submit an objection with confidential 
information that you do not wish to be made available to the public, 
submit the objection as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper objections submitted to the Division of 
Dockets Management, FDA will post your objection, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-N-2819 for ``Emergency Permit Control Regulations; Technical 
Amendments.'' Received objections will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://www.regulations.gov or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit an objection with 
confidential information that you do not wish to be made publicly 
available, submit your objections only as a written/paper submission. 
You should submit two copies total. One copy will include the 
information you claim to be confidential with a heading or cover note 
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The 
Agency will review this copy, including the claimed confidential 
information, in its consideration of comments. The second copy, which 
will have the claimed confidential information redacted/blacked out, 
will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets 
Management. If you do not wish your name and contact information to be 
made publicly available, you can provide this information on the cover 
sheet and not in the body of your comments and you must identify this 
information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, 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, 5001 
Campus Dr., College Park, MD 20740-3835, 240-402-1781.

SUPPLEMENTARY INFORMATION: 

I. Background

    Among other things, our current 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. Sec.  108.25(c)(1) and 108.35(c)(1) (21 CFR 108.25(c)(1) and 
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 
process filing forms: Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 
2541g. (For more information about the new process filing forms, see 
``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.) We announced 
that drafts of the new forms were available for public comment in a 
notice published in the Federal Register of January 14, 2014 (79 FR 
2448). After considering public comment, we modified the content of the 
forms where appropriate and announced the availability of the finalized 
new process filing forms in a notice published in the Federal Register 
of October 8, 2015 (80 FR 60909).

II. Legal Authority

    We are issuing this final 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 of Health and Human 
Services (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, our regulations in part 108 
have long required registration of food processing establishments, 
filing of process information, and maintenance

[[Page 46830]]

of processing and production records for acidified foods and low-acid 
canned foods. Under section 701(e) of the FD&C Act (21 U.S.C. 371(e)), 
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. The Secretary shall publish such proposal and shall afford 
all interested persons an opportunity to present their views thereon, 
orally or in writing. As soon as practicable thereafter, the Secretary 
shall by order act upon the proposal and make such order public. Except 
as provided in section 701(e)(2) of the FD&C Act, the order shall 
become effective at such time as may be specified therein, but not 
before the day following the last day on which objections may be filed 
under section 701(e)(2) of the FD&C Act.

III. The Proposed Rule

    The new process filing forms described in section I 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 in the forms, in the Federal Register of September 22, 
2015 (80 FR 57137), we proposed to 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, we proposed to incorporate the new FDA form numbers. 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.
    In addition, we proposed to make changes to the addresses or 
locations where forms can be found or must be sent. Finally, we 
proposed to remove obsolete references to dates that occurred years ago 
and 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.

IV. Public Comments

    We received one comment on the proposed rule. This comment alerted 
us to the omission of the word ``and'' in the name of the Federal 
Agency that administers the meat and poultry inspection programs under 
the Federal Meat Inspection Act and the Poultry Products Inspection 
Act. The name of that Federal Agency is the ``Food Safety and 
Inspection Service,'' not the ``Food Safety Inspection Service,'' and 
we have revised the rule accordingly.

V. Description of the Final Rule

    The final rule makes those technical amendments to Sec.  108.25, 
``Acidified Foods,'' and Sec.  108.35, ``Thermal Processing of Low-Acid 
Foods Packaged in Hermetically Sealed Containers'' that we described in 
the proposed rule and summarized in section I of this document, with 
the correction noted in section IV of this document. See the amended 
regulatory text of Sec. Sec.  108.25(c)(1) and (2) and 108.35(c)(1) and 
(2) and (i). The final rule will cause the new process filing forms to 
fully replace the forms currently listed in part 108 (i.e. Forms FDA 
2541a and FDA 2541c).

VI. Objections

    This rule is effective as shown in the DATES section, except as to 
any provisions that may be stayed by the filing of proper objections. 
If you will be adversely affected by one or more provisions of this 
regulation, you may file with the Division of Dockets Management (see 
ADDRESSES) either electronic or written objections. You must separately 
number each objection, and within each numbered objection you must 
specify with particularity the provision(s) to which you object, and 
the grounds for your objection. Within each numbered objection, you 
must specifically state whether you are requesting a hearing on the 
particular provision that you specify in that numbered objection. If 
you do not request a hearing for any particular objection, you waive 
the right to a hearing on that objection. If you request a hearing, 
your objection must include a detailed description and analysis of the 
specific factual information you intend to present in support of the 
objection in the event that a hearing is held. If you do not include 
such a description and analysis for any particular objection, you waive 
the right to a hearing on the objection.
    Any objections received in response to the regulation 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. We will publish notice of the objections that we 
have received or lack thereof in the Federal Register.

VII. Economic Analysis of Impacts

    We are publishing this final rule under the formal rulemaking 
process. Executive Order 12866 does not require us to analyze the costs 
and benefits of final 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 final rule amends 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, we are replacing 
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 our 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 certify that the rule 
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 issuing ``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

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after adjustment for inflation is $146 million, using the most current 
(2015) Implicit Price Deflator for the Gross Domestic Product. FDA does 
not expect this final rule to result in any 1-year expenditure that 
would meet or exceed this amount.

VIII. Analysis of Environmental Impact

    FDA has determined, under 21 CFR 25.30(i), that this final 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.

IX. Paperwork Reduction Act of 1995

    This final 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.

X. Federalism

    We have analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that 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 conclude that the 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.

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, part 108 is 
amended as follows:

PART 108--EMERGENCY PERMIT CONTROL

0
1. The authority citation for 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 (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, 5001 Campus Dr., 
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, 
5001 Campus Dr., 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, 5001 Campus Dr., College Park, MD 20740, or at any 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, 5001 
Campus Dr., 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, 5001 Campus Dr., College Park, MD 20740, 
or at any 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, 5001 Campus Dr.,

[[Page 46832]]

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/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, 5001 Campus Dr., 
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, 5001 Campus Dr., 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/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, 5001 Campus Dr., 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 and 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: July 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16968 Filed 7-18-16; 8:45 am]
 BILLING CODE 4164-01-P


