80 FR 57137 - Emergency Permit Control Regulations; Technical Amendments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 183 (September 22, 2015)

Page Range		57137-57141
FR Document		2015-23614

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.

Federal Register, Volume 80 Issue 183 (Tuesday, September 22, 2015)

[Federal Register Volume 80, Number 183 (Tuesday, September 22, 2015)]
[Proposed Rules]
[Pages 57137-57141]
From the Federal Register Online [www.thefederalregister.org]
[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

[[Page 57139]]

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.

[[Page 57140]]

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

Federal Register / Vol. 80, No. 183 / Tuesday, September 22, 2015 / Proposed Rules 57137

II. Purpose and Format of the Public Congress in FSMA. We will not use any 5 p.m., at Chicago Marriott Downtown
Meeting information or data submitted during Magnificent Mile, 540 North Michigan
FDA is holding the public meeting on the public meeting to inform any FSMA Ave, Chicago, IL 60611. Due to limited
the two preventive controls final rules rulemakings where the comment space and time, we encourage all
to address what is different from the periods have closed. persons who wish to attend the meeting
proposals; discuss the plans for There will be an opportunity for to register in advance. There is no fee
guidance documents and outstanding stakeholders who are unable to to register for the public meeting, and
issues that might be addressed in participate in person to join the meeting registration will be on a first-come, first-
guidance; provide an update on the via webcast. (See section III of this served basis. Early registration is
development of implementation work document for more information on the recommended because seating is
plans; and answer questions. webcast option.) limited. Onsite registration will be
These two preventive controls final accepted, as space permits, after all
III. How To Participate in the Public preregistered attendees are seated.
rules are the first of several final rules
Meeting
that will establish the foundation of, Table 1 of this document provides
and central framework for, the modern We are holding the public meeting on information on participation in the
food safety system envisioned by October 20, 2015, from 8:30 a.m. until public meeting.

TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING
Date Electronic address Address Other information

Attend public October 20, 2015, from 8:30 Please preregister at http:// Chicago Marriott Downtown Registration check-in begins
meeting. a.m. to 5 p.m. CDT. www.fda.gov/Food/ Magnificent Mile, 540 North at 8 a.m.
NewsEvents/ Michigan Ave, Chicago, IL
WorkshopsMeetingsConfer- 60611.
ences/default.htm.
View webcast October 20, 2015, from 8:30 Individuals who wish to par- ........................................... The webcast will have closed
a.m. to 5 p.m. CDT. ticipate by webcast are captioning.
asked to preregister at
http://www.fda.gov/Food/
NewsEvents/
WorkshopsMeetingsConfer-
ences/default.htm.
Preregister ..... Register by October 12, 2015 Individuals who wish to par- We encourage the use of There is no registration fee
ticipate in person are asked electronic registration, if for the public meeting.
to preregister at http:// possible.1 .
www.fda.gov/Food/
NewsEvents/
WorkshopsMeetingsConfer-
ences/default.htm.
Request spe- Request by October 6, 2015 Juanita Yates, email: Jua- See For Further Information
cial accom- nita.yates@fda.hhs.gov. Contact.
modations
due to dis-
ability.
Submit elec- ........................................... Submit questions to the FDA ........................................... For more information about
tronic ques- FSMA Technical Assistance the FDA FSMA Technical
tions about Network at http:// Assistance Network, visit
the FSMA www.fda.gov/Food/ http://www.fda.gov/Food/
final rules. GuidanceRegulation/FSMA/ GuidanceRegulation/FSMA/
ucm459719.htm. ucm459719.htm.
1 You may also register via email, mail, or fax. Please include your name, title, firm name, address, and phone and fax numbers in your reg-
istration information and send to: Courtney Treece, Planning Professionals Ltd., 1210 West McDermott St., Suite 111, Allen, TX 75013, 704–
258–4983, FAX: 469–854–6992, email: ctreece@planningprofessionals.com.

IV. Transcripts and Recorded Video on the Agency’s Web site at http:// DEPARTMENT OF HEALTH AND
www.fda.gov. Additionally, we will be HUMAN SERVICES
Please be advised that as soon as a video recording the public meeting.
transcript is available, it will be Once the recorded video is available, it Food and Drug Administration
accessible at http://www.regulations.gov
will be accessible at FDA’s FSMA Web
and at FDA’s FSMA Web site at: 21 CFR Part 108
site at http://www.fda.gov/FSMA.
http://www.fda.gov/FSMA. You may
also view the transcript at the Division Dated: September 17, 2015. [Docket No. FDA–2015–N–2819]
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of Dockets Management (HFA–305), Leslie Kux,
Food and Drug Administration, 5630 Emergency Permit Control
Associate Commissioner for Policy.
Fishers Lane, rm. 1061, Rockville, MD Regulations; Technical Amendments
[FR Doc. 2015–24027 Filed 9–21–15; 8:45 am]
20852. A transcript will also be AGENCY: Food and Drug Administration,
BILLING CODE 4164–01–P
available in either hardcopy or on CD– HHS.
ROM, after submission of a Freedom of
Proposed rule; technical
ACTION:
Information request. The Freedom of
amendments.
Information office address is available

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Federal Register / Vol. 80, No. 183 / Tuesday, September 22, 2015 / Proposed Rules 57139

numbers and changes to the addresses • Amend § 108.35(c)(2) by replacing 2541g. Some of the data entry fields on
or locations where forms can be found ‘‘Form FDA 2541a (food canning the four new process filing forms are not
or must be sent. These changes would establishment process filing for all on current Forms FDA 2541a and FDA
also remove obsolete references to dates methods except aseptic), or Form FDA 2541c. The new forms add certain data
that occurred years ago and would 2541c (food canning establishment entry fields to improve the efficiency of
update the name of the Agency of the process filing for aseptic systems)’’ with FDA’s review of the process filings. For
U. S. Department of Agriculture that a list of the following new forms: Form example, the new forms include data
administers the meat and poultry FDA 2541d (Food Process Filing for entry fields for the ‘‘food product
inspection programs under the Federal Low-Acid Retorted Method); Form FDA group’’ (such as liquid, ready-to-eat
Meat Inspection Act and the Poultry 2541f (Food Process Filing for Water ‘‘breakfast foods’’). In addition, the new
Products Inspection Act. Specifically, Activity/Formulation Control Method); forms provide for ‘‘smart form’’
the proposed rule would: and Form FDA 2541g (Food Process technology using an electronic
• Amend § 108.25(c)(1) and (c)(2) and Filing for Low-Acid Aseptic Systems). submission system. The updated
§ 108.35(c)(1) and (c)(2) to replace the These changes refer to the new form process filing portion of the electronic
obsolete mailing code (HFS–618) listed numbers and forms that FDA is submission system queries the processor
in those provisions with the current introducing. about the processes used to produce the
mailing code (HFS–303) for the FDA • Amend § 108.35(c)(2)(ii) by food and presents only those data entry
office identified in those provisions. inserting ‘‘LACF Registration fields that are applicable. As a result,
• Amend § 108.25(c)(1) and (c)(2) and Coordinator (HFS–303)’’ before ‘‘Center processors will no longer need to
§ 108.35(c)(1) and (c)(2) to provide an for Food Safety and Applied Nutrition.’’ evaluate whether particular data entry
Internet address where forms can be This change would provide greater fields are applicable to their products.
found or submitted. The new text would specificity as to the FDA office that For example, when a processor submits
state that the forms are available on our should receive information for purposes a process filing for a product that is
Web site at http://www.fda.gov/Food/ of § 108.35(c)(2)(ii). processed using a low-acid retorted
GuidanceRegulation/ • Amend § 108.35(i) (which refers to method with a process mode of
FoodFacilityRegistration/ ‘‘the meat and poultry inspection ‘‘agitating,’’ smart form technology
AcidifiedLACFRegistration/ program of the Animal and Plant Health would bypass questions that are not
ucm2007436.htm and, for electronic Inspection Service of the Department of applicable to this process mode option.
submission, would refer to FDA’s Agriculture’’) by replacing ‘‘Animal and We estimate that the additional time it
Industry Systems Web site at Plant Health Inspection Service’’ with would take processors to complete the
www.access.fda.gov. ‘‘Food Safety Inspection Service.’’ We new information requested on the new
• Amend § 108.25(c)(1) by deleting are making this change because the forms would be offset by the time
‘‘Commercial processors presently so Food Safety and Inspection Service of processors will save by not having to
the U.S. Department of Agriculture now evaluate whether certain data entry
engaged shall register within 120 days
administers the meat and poultry fields on Form FDA 2541a or FDA
after the effective date of this
inspection program under the Federal 2541c are applicable to their products.
regulation.’’ We propose to delete this
Meat Inspection Act and the Poultry Hence, we propose to certify that the
sentence because the effective date
Products Inspection Act, and not the rule, if finalized, will not have a
occurred years ago, so the sentence is no
Animal and Plant Health Inspection significant economic impact on a
longer necessary. We also propose to
Service. substantial number of small entities.
replace the sentence stating that Section 202(a) of the Unfunded
‘‘Foreign processors shall register within IV. Proposed Effective Date Mandates Reform Act of 1995 requires
120 days after the effective date of this We propose that any final rule that Agencies prepare a written
regulation or before any offering of resulting from this rulemaking process statement, which includes an
foods for import into the United States, become effective 30 days after its date assessment of anticipated costs and
whichever is later,’’ with a new of publication in the Federal Register. benefits, before proposing ‘‘any rule that
sentence stating that ‘‘Foreign includes any Federal mandate that may
processors shall register before any V. Economic Analysis of Impacts
result in the expenditure by State, local,
offering of foods for import into the We are publishing this proposed rule and tribal governments, in the aggregate,
United States.’’ We propose to make this under the formal rulemaking process. or by the private sector, of $100,000,000
change because the effective date Executive Order 12866 does not require or more (adjusted annually for inflation)
occurred years ago, so reference to the us to analyze the costs and benefits of in any one year.’’ The current threshold
effective date is no longer necessary. proposed rules that we publish under after adjustment for inflation is $144
• Amend § 108.25(c)(2) by replacing this rulemaking process. million, using the most current (2014)
‘‘form FDA 2541a (food canning The Regulatory Flexibility Act Implicit Price Deflator for the Gross
establishment process filing form for all requires Agencies to analyze regulatory Domestic Product. FDA does not expect
methods except aseptic)’’ with ‘‘Form options that would minimize any this proposed rule to result in any 1-
FDA 2541e (Food Process Filing for significant impact of a rule on small year expenditure that would meet or
Acidified Method).’’ This change would entities. The proposed rule would exceed this amount.
reflect the new form number and form amend §§ 108.25 and 108.35 to delete
that FDA is introducing. obsolete references to long-expired VI. Analysis of Environmental Impact
• Amend § 108.35(c)(1) by deleting
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effective dates, make changes to FDA FDA has determined, under 21 CFR
the sentence stating that ‘‘Commercial addresses or locations, and reflect new 25.30(i), that this proposed rule is of a
processors presently so engaged shall process filing forms. With regard to the type that does not individually or
register not later than July 13, 1973.’’ new process filing forms, FDA would cumulatively have a significant effect on
Given the passage of time since replace references to Forms FDA 2541a the human environment. Therefore,
§ 108.35(c)(1) was issued, reference to and FDA 2541c with references to four neither an environmental assessment
the date of July 13, 1973, is no longer new process filing forms: Forms FDA nor an environmental impact statement
necessary. 2541d, FDA 2541e, FDA 2541f, and FDA is required.

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57140 Federal Register / Vol. 80, No. 183 / Tuesday, September 22, 2015 / Proposed Rules

VII. Paperwork Reduction Act of 1995 § 108.25 Acidified foods. each container size. Filing of this
* * * * * information does not constitute
This proposed rule contains
(c)(1) Registration. A commercial approval of the information by the Food
information collection provisions that
processor, when first engaging in the and Drug Administration, and
are subject to review by the Office of
manufacture, processing, or packing of information concerning processes and
Management and Budget (OMB) under
acidified foods in any State, as defined other data so filed shall be regarded as
the Paperwork Reduction Act of 1995 trade secrets within the meaning of 21
(44 U.S.C. 3501–3520). These in section 201(a)(1) of the act, shall, not
later than 10 days after first so engaging, U.S.C. 331(j) and 18 U.S.C. 1905. This
collections of information have been information shall be submitted on Form
previously approved under OMB register and file with the Food and Drug
Administration on Form FDA 2541 FDA 2541e (Food Process Filing for
control number 0910–0037 which Acidified Method). Forms are available
expires September 30, 2017. (food canning establishment
registration) information including, but from the LACF Registration Coordinator
VIII. Federalism not limited to, the name of the (HFS–303), Center for Food Safety and
establishment, principal place of Applied Nutrition, Food and Drug
FDA has analyzed this proposed rule Administration, 5100 Paint Branch
in accordance with the principles set business, the location of each
establishment in which that processing Pkwy., College Park, MD 20740, or at
forth in Executive Order 13132. FDA Food and Drug Administration district
has determined that the proposed rule, is carried on, the processing method in
terms of acidity and pH control, and a office. The completed form shall be
if finalized, would not contain policies submitted to the LACF Registration
that would have substantial direct list of foods so processed in each
establishment. These forms are available Coordinator (HFS–618), Center for Food
effects on the States, on the relationship Safety and Applied Nutrition, Food and
between the National Government and from the LACF Registration Coordinator
(HFS–303), Center for Food Safety and Drug Administration, 5100 Paint Branch
the States, or on the distribution of Pkwy., College Park, MD 20740. These
power and responsibilities among the Applied Nutrition, Food and Drug
Administration, 5100 Paint Branch forms also are available on the Food and
various levels of government. Drug Administration’s Web site at
Accordingly, we tentatively conclude Pkwy., College Park, MD 20740, or at
any Food and Drug Administration http://www.fda.gov/Food/Guidance
that the proposed rule does not contain Regulation/FoodFacilityRegistration/
policies that have federalism district office. The completed form shall
be submitted to the Center for Food AcidifiedLACFRegistration/
implications as defined in the Executive ucm2007436.htm. For electronic
Order and, consequently, a federalism Safety and Applied Nutrition (HFS–
565), Food and Drug Administration, submission go to FDA’s Industry
summary impact statement is not Systems Web site at
required. 5100 Paint Branch Pkwy., College Park,
www.access.fda.gov.
MD 20740. These forms also are
IX. Additional Information Regarding available on the Food and Drug * * * * *
Comments Administration’s Web site at http:// ■ 3. In § 108.35, revise paragraphs (c)(1),
www.fda.gov/Food/Guidance (c)(2) introductory text, (c)(2)(ii), and (i)
Interested persons may submit either to read as follows:
electronic comments regarding this Regulation/FoodFacilityRegistration/
document to http://www.regulations.gov AcidifiedLACFRegistration/ § 108.35 Thermal processing of low-acid
or written comments to the Division of ucm2007436.htm. For electronic foods packaged in hermetically sealed
Dockets Management (see ADDRESSES). It submission go to FDA’s Industry containers.
is only necessary to send one set of Systems Web site at * * * * *
comments. Identify comments with the www.access.fda.gov. Foreign processors (c) * * *
docket number found in brackets in the shall register before any offering of (1) Registration. A commercial
heading of this document. Received foods for import into the United States. processor when first engaging in the
comments may be seen in the Division Commercial processors duly registered manufacture, processing, or packing of
of Dockets Management between 9 a.m. under this section shall notify the Food thermally processed low-acid foods in
and 4 p.m., Monday through Friday, and and Drug Administration not later than hermetically sealed containers in any
will be posted to the docket at http:// 90 days after the commercial processor state, as defined in section 201(a)(1) of
www.regulations.gov. ceases or discontinues the manufacture, the act, shall, not later than 10 days after
processing, or packing of the foods in first so engaging, register with the Food
List of Subjects in 21 CFR Part 108 any establishment, except that this and Drug Administration on Form FDA
Administrative practice and notification shall not be required for 2541 (food canning establishment
procedure, Foods, Reporting and temporary cessations due to the registration) information including (but
recordkeeping requirements. seasonal character of an establishment’s not limited to) his name, principal place
production or by temporary conditions of business, the location of each
Therefore, under the Federal Food, including, but not limited to, labor establishment in which such processing
Drug, and Cosmetic Act and under disputes, fire, or acts of God. is carried on, the processing method in
authority delegated to the Commissioner
(2) Process filing. A commercial terms of the type of processing
of Food and Drugs, it is proposed that
processor engaged in the processing of equipment employed, and a list of the
21 CFR part 108 be amended as follows:
acidified foods shall, not later than 60 low-acid foods so processed in each
PART 108—EMERGENCY PERMIT days after registration, and before such establishment. These forms are
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CONTROL packing any new product, provide the available from the LACF Registration
Food and Drug Administration Coordinator (HFS–303), Center for Food
■ 1. The authority citation for 21 CFR information on the scheduled processes Safety and Applied Nutrition, Food and
part 108 continues to read as follows: including, as necessary, conditions for Drug Administration, 5100 Paint Branch
heat processing and control of pH, salt, Pkwy., College Park, MD 20740, or at
Authority: 21 U.S.C. 342, 344, 371.
sugar, and preservative levels and any Food and Drug Administration
■ 2. In § 108.25, revise paragraphs (c)(1) source and date of the establishment of district office. The completed form shall
and (c)(2) to read as follows: the process, for each acidified food in be submitted to the LACF Registration

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Document Created: 2015-12-15 09:35:53
Document Modified: 2015-12-15 09:35:53

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Proposed rule; technical amendments.
Dates		Submit either electronic or written comments on the proposed rule by December 7, 2015.
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.
FR Citation		80 FR 57137
CFR Associated		Administrative Practice and Procedure; Foods and Reporting and Recordkeeping Requirements

80 FR 57137 - Emergency Permit Control Regulations; Technical Amendments

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 183 (September 22, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration