[Federal Register Volume 75, Number 186 (Monday, September 27, 2010)]
[Notices]
[Pages 59268-59272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-24089]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0434]
Draft Guidance for Industry: Acidified Foods; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Guidance for Industry:
Acidified Foods.'' The draft guidance, when finalized, will complement
FDA's regulations regarding acidified foods, including regulations for
specific current good manufacturing practice (CGMP), establishment
registration, and process filing. The draft guidance is intended to
assist commercial food processors in determining whether their food
products are subject to these regulations. The draft guidance also is
intended to assist processors of acidified foods in ensuring safe
manufacturing, processing, and packing processes and in employing
appropriate quality control procedures. Under the draft guidance,
processors of non-acidified foods (e.g., some acid foods or fermented
foods) who are not subject to the acidified food regulations may choose
to voluntarily register and file scheduled processes with us using
existing forms (Forms FDA 2541 and 2541a). If such processors
voluntarily submit this information, we plan to make the results of any
FDA evaluation of the information available to our investigators, e.g.,
during inspections of food facilities and during evaluations of foods
offered for import.
DATES: Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments concerning the
draft guidance by December 27, 2010. Submit either electronic or
written comments concerning the collection of information provisions by
December 27, 2010.
ADDRESSES: Submit electronic comments on the draft guidance and the
proposed collection of information provisions to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit written requests for single
copies of the draft guidance entitled ``Guidance for Industry:
Acidified Foods'' to the Office of Food Safety, Center for Food Safety
and Applied Nutrition (HFS-302), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740. Send two self-addressed
adhesive labels to assist that office in processing your request, or
fax your request to 301-436-2669. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance.
FOR FURTHER INFORMATION CONTACT:
With regard to the draft guidance document: Michael Mignogna,
Center for Food Safety and Applied Nutrition (HFS-302), Food and Drug
Administration, 5100 Paint Branch Parkway, College Park, MD 20740, 301-
436-1565.
With regard to the information collection: Denver Presley, Jr.,
Office of Information Management, Food and Drug Administration, 1350
Piccard Dr., PI50-400B, Rockville, MD 20857, 301-796-3793.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance entitled
``Guidance for Industry: Acidified Foods.'' The draft guidance, when
finalized, will complement FDA's regulations regarding acidified foods,
including regulations for specific CGMP, establishment registration,
and process filing. The draft guidance is intended to assist commercial
food processors in determining whether their food products are subject
to these regulations. Under the draft guidance, processors of acid
foods and fermented foods who conclude that such foods they produce are
not also acidified foods\1\ may voluntarily register and file scheduled
processes with us using existing forms (Forms FDA 2541 and 2541a) for
acidified foods. Processors of
[[Page 59269]]
acid foods and fermented foods, which foods are not also acidified
foods, would not be subject to the acidified food regulations. When
processors of such acid foods or fermented foods voluntarily register
and file scheduled processes with us using existing forms, we plan to
make the results of any FDA evaluation of such information available to
our investigators, e.g., during inspections of food facilities and
during evaluations of foods offered for import, to facilitate
investigators' decisions about the regulatory status of those food
products. The draft guidance recommends that such processors, who
voluntarily file scheduled processes with us, file a single scheduled
process for each product, rather than filing a separate form for each
container size, as required for processors of acidified foods. The
draft guidance also is intended to assist processors of acidified foods
in ensuring safe manufacturing, processing, and packing processes and
in employing appropriate quality control procedures. FDA is issuing
this draft guidance as a level 1 draft guidance consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent FDA's current thinking on this topic. It
does not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statutes
and regulations.
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\1\ Fermented foods, such as some kinds of sauerkraut, cucumber
pickles, and green olives, are low-acid foods subjected to the
action of acid-producing microorganisms to reduce the pH of the
food. Not all fermented foods meet the definition of ``acidified
foods'' in 21 CFR 114.3(b). However, some fermented foods that
contain acid are also acidified foods. We also note that fermented
dairy products, such as yogurt, belong to a separate category that
is not relevant to the fermented foods that are discussed in this
guidance.
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II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3520), Federal agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Title: Recommendations for Establishment-Specific Written Quality
Control Plans and Recordkeeping for Acidified Foods, and Voluntary
Registration and Process Filing.
Description of respondents: The likely respondents to this proposed
collection of information are processors of acidified foods as well as
processors of foods that may not be acidified foods who voluntarily
choose to provide us with information about these foods.
Description: The draft guidance is intended to assist processors of
acidified foods in ensuring safe manufacturing, processing, and packing
processes and in employing appropriate quality control procedures.
Further, this guidance notes that processors who are not certain as to
whether specific food products, including foods that may be acid or
fermented foods, are acidified foods subject to registration and
process filing requirements may provide us with information about these
products by voluntarily submitting Forms FDA 2541 and 2541a. This
guidance also recommends that firms prepare a written plan to
investigate product lots for signs of spoilage and document any
investigation and corrective actions relevant to spoilage.
This draft guidance also refers to previously approved collections
of information found in FDA regulations. The collections of information
in Sec. 108.25 (21 CFR 108.25) and part 114 (21 CFR part 114) have
been approved under OMB control no. 0910-0037.
Under the draft guidance, when processors voluntarily submit Forms
FDA 2541 and 2541a for foods that they conclude are not acidified
foods, we intend to continue to evaluate the process information to
determine whether it is consistent with a processor's conclusion that a
food is not an acidified food. The burden approved under OMB control
no. 0910-0037 does not include the burden associated with voluntary
reporting.
The burden approved under OMB control no. 0910-0037 also does not
include the burden associated with the recommendations in the draft
guidance to prepare a written plan (the establishment-specific written
plan) that includes quality control procedures with respect to spoilage
and to document spoilage events if they occur. We estimate the
recordkeeping burden of the draft guidance by assuming that those in
the industry that process acidified foods and that do not currently
follow the recommendations put forth in the draft guidance will find it
of value to do so. The conservative assumptions and estimates made in
this analysis regarding the recordkeeping burden are intended to
provide the upper bound estimates of anticipated impact of the guidance
on the acidified food industry and others that choose to file voluntary
submissions with FDA. These burdens would be realized if every
operation, plant, or processor of acidified foods that does not already
follow the recommendations of the draft guidance would choose to do so.
We estimate the proposed collection of information consists of one-
time and recurring recordkeeping burdens, summarized in table 1 of this
document.
We estimate the reporting burden of the draft guidance by assuming
that processors who conclude that their specific food products are acid
foods or fermented foods, rather than acidified foods subject to
registration and process filing requirements, will find it of value to
provide us with information about their products by voluntarily
submitting Forms FDA 2541 and 2541a. The conservative assumptions and
estimates made in this analysis regarding the reporting burden are
intended to provide the upper bound estimates of anticipated impact of
the guidance on such processors. These burdens would be realized if
every operation, plant, or processor that concludes that specific food
products are acid or fermented foods that are not also acidified foods,
would choose to submit Forms FDA 2541 and 2541a. We estimate that the
proposed collection of information consists of one-time and recurring
reporting burdens, summarized in table 2 of this document.
Current Information Available to FDA
The existing reporting requirements in Sec. 108.25 provide us with
information about the acidified foods industry, including the total
number of establishment registrations, the annual number of
establishment registrations, and the annual number of processes filed.
As of February 4, 2010, there are a total of 4,872 establishments
registered with FDA in accordance with Sec. 108.25 as commercial
processors of acidified foods.
[[Page 59270]]
The available data for the past 6 years (2004 through 2009)\2\
indicate that, on average, there are 6,754 process filings submitted by
an average of 892 acidified foods establishments each year. In
addition, since 2004, when we began implementing an electronic filing
system, approximately 750 establishments that registered using Form FDA
2541 submitted process filings to us for food products that we
determined were not covered by either part 113 (21 CFR part 113) or
part 114. The available information includes the number of
establishments that submitted such filings, but not the number of
filings.
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\2\ We began implementing an electronic filing system in 2004
and used information available in that system for this analysis.
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We also have data on estimated reporting burdens, available to us
from our most recent analysis of the reporting burden under parts 113
and 114 (OMB control no. 0910-0037; 73 FR 11649 at 11650, March 4,
2008). In that analysis, we estimated that there are 8,950
establishments that keep records on an annual basis as processors of
acidified foods or low-acid canned foods (LACF), that 515
establishments submit a registration form (Form FDA 2541) on an annual
basis, for either acidified foods or LACF; that it takes 0.17 hours to
complete Form FDA 2541; that 1,489 establishments each submit 8.62
process filings (Form FDA 2541a) on an annual basis; and that it takes
0.33 hours to complete Form FDA 2541a. We use this information to
estimate the reporting burden associated with the draft guidance.
In addition to establishment registration and process filing under
Sec. 108.25, acidified food establishments also must promptly report
to us any instance of spoilage when the nature of the spoilage is such
that it has potential health-endangering significance and any lot of
such food has in whole or in part entered distribution in commerce
(Sec. 108.25(d)). In the period from 2004 to January 2010, we received
1 report of spoilage of a commercially distributed acidified food.
Therefore, for this analysis, we assume that such spoilage events are
rare.
Recordkeeping Burden
Establishment-Specific Written Plan Including Quality Control
Procedures for Acidified Foods (One-Time Burden): Currently, acidified
foods establishments must employ appropriate quality control procedures
to ensure that finished foods do not present a health hazard (Sec.
114.80(a)). To assist manufacturers in employing appropriate quality
control procedures under Sec. 114.80(a), the draft guidance recommends
that each acidified food establishment prepare a written plan (the
establishment-specific written plan) that includes quality control
procedures with respect to spoilage, regardless of whether the spoilage
has potential health-endangering significance. Currently existing
models (e.g., Ref. 1) suitable for use in developing such a written
plan are readily available to acidified foods establishments.
Because we rarely receive reports under Sec. 108.25(d) regarding
spoilage of commercially distributed acidified foods with potential
health-endangering significance, for this analysis we assume that the
quality control procedures of all acidified foods establishments
currently address spoilage. Because the potential health consequences
of spoilage may not be apparent in the initial stages of an
investigation of spoilage, we assume that these establishments address
spoilage regardless of the potential for health consequences. We also
assume that the quality control procedures of 80 percent of registered
establishments address spoilage through an establishment-specific
written plan such as the one recommended in the draft guidance. We
further assume that the quality control procedures of the remaining 20
percent of registered establishments (i.e., 4,872 x 0.20 = 974.4,
rounded to 974 establishments) address spoilage by relying on a
generally available document (e.g., Ref. 1), the establishment's
unwritten procedures, or a combination of both. Based on our experience
with quality control procedures, we estimate it would take 8 hours for
an acidified foods establishment to prepare an establishment-specific
written plan. If all of the 974 registered establishments that do not
currently have an establishment-specific written plan develop such a
plan, the associated recordkeeping burden would be 7,792 hours (974
establishments x 8 hours/establishment). This would be a one-time
recordkeeping burden. Table 1 of this document includes the estimated
one-time recordkeeping burden associated with preparation of
establishment-specific written plans.
Documentation of Spoilage for Acidified Foods (Recurring Burden):
The draft guidance recommends that an acidified food establishment
document all investigations and corrective actions relevant to
spoilage. We assume that an acidified food establishment that currently
has an establishment-specific written plan in place to address spoilage
also currently documents investigations and corrective actions relevant
to spoilage. We assume that spoilage problems are relatively rare and,
therefore, estimate that one spoilage event per establishment occurs
every 5 years. Accordingly, we estimate 195 spoilage events requiring
recordkeeping will occur (974 establishments that do not currently have
an establishment-specific written plan x 0.2 events/establishment =
194.8 events, rounded to 195). Assuming that establishments follow
procedures such as those in Ref. 1, and based on our experience with
investigations and corrective actions, we estimate it would take 2
hours to document a spoilage event. Thus, we estimate a recurring
recordkeeping burden of 390 hours (195 events x 2 hours/event = 390
hours). Table 1 of this document includes the estimated recurring
recordkeeping burden associated with documenting investigations of
spoilage events.
Table 1.--Estimated One-Time and Recurring Recordkeeping Burden\1\
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No. of Annual Frequency Total Annual
Activity Recordkeepers per Recordkeeping Records Hours per Record Total Hours
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Quality 974 1 974 8.00 7,792
control
plan to
address
spoilage\
2\
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Spoilage 195 1 195 2.00 390
event
documenta
tion
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Total one-time burden 7,792
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[[Page 59271]]
Total recurring burden 390
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ One-time recordkeeping burden.
Reporting Burden
Voluntary Registration (Form FDA 2541) (One-Time and Recurring
Burdens): Currently, we place information documenting whether acidified
food establishments have made appropriate submissions on Forms FDA 2541
and 2541a in an acidified food database that is readily available to
our investigators who inspect food facilities or evaluate foods offered
for import. This information facilitates decisions by our investigators
about the regulatory status of specific food products.
In our experience, establishments are cautious about decisions they
make about the regulatory status of their products, and many
establishments that process non-acidified fermented foods and/or acid
foods have contacted us with information about their facilities and the
products they make. For example, our records show that, since 2004, we
have informed approximately 750 different registered establishments
that submitted electronic process filings that a food product that was
the subject of a process filing was not covered by either part 113 (as
a low-acid food) or part 114 (as an acidified food). In the past, we
did not add information about these products to the acidified foods
databases that are available to our investigators.
The draft guidance clarifies that establishments that conclude that
the foods they process are acid foods or fermented foods that are not
also acidified foods, may voluntarily register and file scheduled
processes with us using Forms FDA 2541 and 2541a. As we do currently,
if we receive information from such establishments, we would evaluate
the submitted information to determine whether it is consistent with
the establishment's conclusion that a product is not an acidified food.
We plan to make the results of these evaluations available to our
investigators, for example, during inspections of food facilities and
during evaluations of foods offered for import. If we conclude that the
submitted information is not consistent with the processor's conclusion
that its products are not acidified foods, we may request additional
information to assist us in evaluating the processor's conclusion about
its products or take other action as appropriate. From our past
experience, we believe that many processors of foods that may be acid
foods or fermented foods that are not also acidified foods would choose
to submit information to us on Forms FDA 2541 and 2541a because doing
so would facilitate decisions by our investigators about the regulatory
status of specific food products.
We estimate that there are 3,000 establishments that process
products that they would conclude are acid foods or fermented foods
that are not also acidified foods--4 times the approximate number of
registered establishments (750) that have submitted process filings to
FDA for food products we determined were not covered by either part 113
or part 114. We assume that all 3,000 establishments are not already
registered as processors of acidified foods or LACF. Because 750 of
these establishments have already registered voluntarily using Form FDA
2541, we estimate that the number of establishments that may register
for the first time under the draft guidance is 2,250 establishments
(3,000 - 750 = 2,250), resulting in a one-time reporting burden of 383
hours (2,250 establishments x 0.17 hours/establishment = 382.5 hours,
rounded to 383 hours). Table 2 of this document includes the estimated
one-time reporting burden for establishments that conclude that their
foods are acid foods or fermented foods that are not also acidified
foods, and voluntarily register their facilities in the first year
after the draft guidance is issued.
After this initial registration, we also estimate that, on average,
a number of establishments equal to 6 percent of the 3,000 total
estimated establishments that will voluntarily register in the first
year (i.e., 0.06 x 3,000 establishments = 180 establishments) will
voluntarily register using Form FDA 2541 each year, resulting in an
annual reporting burden of 31 hours (180 establishments x 0.17 hours/
establishment = 30.6 hours, rounded to 31 hours). Proportionally, this
would be comparable to the current percentage of acidified foods and
LACF establishments that, on average, register using Form FDA 2541 each
year (515 establishments that register on an annual basis/8,950
establishments that keep records on an annual basis x 100 = 5.75
percent rounded to 6 percent). Table 2 of this document includes the
estimated recurring annual reporting burden for establishments that
process foods that they conclude are acid foods or fermented foods that
are not also acidified foods, and that would voluntarily register their
facilities.
Voluntary Process Filing (Form FDA 2541a) (One-Time and Recurring
Burdens): As discussed, we do not have information about the number of
process filings voluntarily submitted by firms that registered their
establishments but whose food products we determined were not covered
by either part 113 or part 114. However, we do have information that,
on average, over the 6-year period from 2004 through 2009, there was a
total of 6,754 annual process filings submitted by an average of 892
acidified foods establishments each year, and that there were 4,872
registered acidified foods establishments; from this information we
calculate that, on average, 18 percent of registered acidified foods
establishments submit process filings each year (892 establishments/
4,872 establishments x 100 = 18.3 percent, rounded to 18 percent). To
be conservative, we also estimate that, on average, acidified foods
establishments submitted process filings for 3 container sizes per
product and that the total number of products reported by acidified
foods establishments each year during that period was thus 2,251
products (6,754 process filings/3 container sizes/product = 2,251.33
products, rounded to 2,251 products). For the purpose of this analysis,
we estimate that, on average, 18 percent of establishments that process
foods that they conclude are acid foods or fermented foods that are not
also acidified foods in a given year will submit process filings; i.e.,
540 establishments (0.18 x 3,000 establishments = 540 establishments).
To be conservative, we also estimate that, on average, the 540
establishments that would submit process filings in a given year will
submit process filings for twice as many products as would be submitted
by acidified foods establishments; per the
[[Page 59272]]
recommendations in the draft guidance, these establishments could
submit a single process form that covers all container sizes of a
product. Thus, the estimated number of annual voluntary process filings
is 2,725 process filings (2,251 products/892 establishments x 540
establishments x 2 = 2,725.4 process filings, rounded to 2,725). On
average, we calculate that the annual frequency of reporting would be 5
process filings (2,725 process filings/540 establishments = 5.04,
rounded to 5). For the purpose of this analysis, we use the rounded
number of process filings (i.e., 5) and, thus, calculate that the
estimated recurring reporting burden for submission of Form 2541a is
2,700 process filings rather than 2,725 process filings (540
establishments x 5 process filings per establishment = 2,700 process
filings), resulting in an annual reporting burden of 891 hours (2,700
process filings x 0.33 hours/process filing = 891 hours). Table 2 of
this document includes the estimated one-time and recurring reporting
burden for establishments that voluntarily submit process filings for
foods that they conclude are acid foods or fermented foods that are not
also acidified foods.
We also estimate that all 3,000 establishments that process foods
that they conclude are acid foods or fermented foods that are not also
acidified foods and voluntarily register their establishments will
submit a total of 30,000 process filings in the first year--i.e., twice
as many process filings as would be submitted, on average, by any given
establishment on an annual basis (2 x 5 process filings/establishment
on an annual basis x 3,000 establishments = 30,000 process filings),
resulting in a one-time reporting burden of 9,900 hours (30,000 process
filings x 0.33 hours/establishment = 9,900 hours). Table 2 of this
document includes the estimated one-time reporting burden for
establishments that voluntarily submit process filings for fermented
foods and/or acid foods.
Table 2.--Estimated One-Time and Recurring Reporting Burden\1\
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Annual Frequency Total Annual
Activity No. of Reporters per Reporter Records Hours per Record Total Hours
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Registrati 2,250 1 2,250 0.17 383
on (Form
FDA
2541)\2\
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Registrati 180 1 180 0.17 31
on (Form
FDA 2541)
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Process 3,000 10 30,000 0.33 9,900
filing
(Form FDA
2541a)\2\
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Process 540 5 2,700 0.33 891
filing
(Form FDA
2541a)
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Total one-time burden 10,283
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Total recurring burden 922
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ One-time reporting burden.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed 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.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
http://www.regulations.gov or at http://www.fda.gov/FoodGuidances.
V. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen between
9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the Web
site address, but FDA is not responsible for any subsequent changes to
Web site after this document publishes in the Federal Register.)
1. Codex Alimentarius Commission, Recommended International Code
of Hygienic Practice for Low and Acidified Low Acid Canned Foods
CAC/RCP 23-1979, Rev. 2 (1993), Available at http://www.codexalimentarius.net/download/standards/24/CXP_023e.pdf,
Accessed and printed on June 17, 2008.
Dated: September 21, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-24089 Filed 9-24-10; 8:45 am]
BILLING CODE 4160-01-S