[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Draft Guidance for Industry: Acidified Foods; Availability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availability of a draft guidance entitled ``Guidance for Industry: 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 The draft guidance, when finalized, will complement 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 The draft guidance is intended to 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 The draft guidance also is 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 Under the draft guidance, 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this draft guidance before it begins work on the final version of the 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draft guidance by December 27, 2010.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ADDRESSES:  Submit electronic comments on the draft guidance and the 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
----------------------------------------------------------------------------------------------------------------
Registrati               2,250                     1               2,250                0.17                 383
 on (Form
 FDA
 2541)\2\
----------------------------------------------------------------------------------------------------------------
Registrati                 180                     1                 180                0.17                  31
 on (Form
 FDA 2541)
----------------------------------------------------------------------------------------------------------------
Process                  3,000                    10              30,000                0.33               9,900
 filing
 (Form FDA
 2541a)\2\
----------------------------------------------------------------------------------------------------------------
Process                    540                     5               2,700                0.33                 891
 filing
 (Form FDA
 2541a)
----------------------------------------------------------------------------------------------------------------
Total one-time burden                                                                                     10,283
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Total recurring burden                                                                                       922
----------------------------------------------------------------------------------------------------------------
\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