[Federal Register: April 21, 2004 (Volume 69, Number 77)]
[Page 21549-21551]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003N-0525]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Hazard Analysis and 
Critical Control Point; Procedures for the Safe and Sanitary Processing 
and Importing of Juice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by May 21, 

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that comments be faxed to the 
Office of Information and

[[Page 21550]]

Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for FDA, FAX: 

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Hazard Analysis and Critical Control Point (HAACP); Procedures for the 
Safe and Sanitary Processing and Importing of Juice (OMB Control Number 

    These regulations mandate the application of HACCP procedures to 
fruit and vegetable juice processing. HACCP is a preventative system of 
hazard control that can be used by all food processors to ensure the 
safety of their products to consumers. A HACCP system of preventive 
controls is the most effective and efficient way to ensure that these 
food products are safe. FDA's mandate to ensure the safety of the 
nation's food supply is derived principally from the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 321 et seq.). Under the 
act, FDA has authority to ensure that all foods in interstate commerce, 
or that have been shipped in interstate commerce, are not contaminated 
or otherwise adulterated, are produced and held under sanitary 
conditions, and are not misbranded or deceptively packaged; under 21 
U.S.C. 371, the act authorizes the agency to issue regulations for its 
efficient enforcement. The agency also has authority under the Public 
Health Service Act (42 U.S.C. 264) to issue and enforce regulations to 
prevent the introduction, transmission, or spread of communicable 
diseases from one State to another other State. Information development 
and recordkeeping are essential parts of any HACCP system. The 
information collection requirements are narrowly tailored to focus on 
the development of appropriate controls and document those aspects of 
processing that are critical to food safety. Through these regulations, 
FDA is implementing its authority under section 402(a)(4) of the act 
(21 U.S.C. 342(a)(4)).
    In the Federal Register of December 8, 2003 (68 FR 68400), FDA 
asked for public comment on the information collection. FDA received 
one comment. The comment stated that the agency had underestimated the 
annual recordkeeping burden of the regulation. The comment identified 
the following three sources of underestimated burden:
    1. The comment stated that we underestimated the burden of 
validation required of importers in 21 CFR 120.14. We estimated the 
burden to be 4 hours, whereas the comment said that validation requires 
30 to 40 hours per importer.
    2. The comment stated that we underestimated the time required to 
document the monitoring of critical control points (21 CFR 
120.8(b)(7)). We estimated 36 seconds; the comment said that 2 to 3 
minutes is a better estimate.
    3. The comment stated that we underestimated the number of times 
per week that processors verify records in accordance with 21 CFR 
120.11. We estimated once per week but, according to the comment, many 
processors verify records more often. The comment said that some 
processors verify records daily.
    We have considered the three points raised in the comment. We will 
revise the estimated burden in response to the first point, but we find 
that the other two points do not require a revision of the estimated 
burden. The following are our detailed responses:
    1. Part of the difference between our estimated burden under 21 CFR 
120.14 and the estimate in the comment is that we computed burden per 
foreign source (308 entities) while the comment computes burden per 
importer (120 entities). Our burden per importer for validation is 
about 10 hours per year, which is still less than the comment's 
estimate but by a smaller order of magnitude. If foreign processors 
deal with multiple importers, the comment's estimate of 30 to 40 hours 
per importer is plausible. We therefore adjust the last line in the 
table in response to the comment. The hours per record change from 4 to 
12 (column 5 of the table), and the total burden changes from 1,232 to 
3,696 hours (column 6 of the table). This total burden corresponds to a 
burden of about 30 hours per importer.
    2. The comment on documenting the monitoring of critical control 
points reflects some confusion about our calculation as presented in 
the burden table. Our estimate of 0.6 minutes per record is an average 
based on our overall estimate of the amount of additional recordkeeping 
time per hour required by the rule (on average an additional 3 minutes 
per hour). Some records will require more time to keep and others less. 
The comment may be correct that some records may take at least 2 to 3 
minutes to make. However, the comment does not purport, and FDA does 
not believe, that all records will require that amount of time. 
Furthermore, many firms are already voluntarily performing a 
significant amount of the activities required to keep the records 
required by the rule to maintain good quality control to protect their 
brand value. Our estimate of the recordkeeping burden attributable to 
this rule is only for those additional activities that firms have not 
been doing prior to the rule, but undertake to comply with the rule.
    3. The verification burden under 21 CFR 120.11 is based on the 
number of records that need to be verified. We say that each record 
must be verified within a week, so verification can be done weekly. But 
the burden is the same if verification is done twice a week or daily 
because the number of records to be verified is the same. So the burden 
would not change if we assumed more frequent verification.
    FDA estimates the burden of this collection of information as 

                               Table 1.--Estimated Annual Recordkeeping Burden\1\
         21 CFR Sections                No. of        Frequency of    Total Annual      Hours per    Total Hours
                                    Recordkeepers     Recordkeeping      Records         Record
120.6(c) and 120.12(a)(1) and          1,875             365            684,375            0.1        68,438
120.7, 120.10(a), and                  2,300               1.1            2,530           20          50,600
 120.12(a)(2), (b), and (c)
120.8(b)(7) and 120.12(a)(4)(i)        1,450          14,600         21,170,000            0.01      211,700
 and (b)
120.10(c) and 120.12(a)(4)(ii)         1,840              12             22,080            0.1         2,208
 and (b)

[[Page 21551]]

120.11(a)(1)(iv), 120.11 (a)(2),       1,840              52             95,680            0.1         9,568
 and 120.12 (a)(5)
120.11(b) and 120.12(a)(5) and         1,840               1              1,840            4           7,360
120.11(c) and 120.12(a)(5) and         1,840               1              1,840            4           7,360
120.14(a)(2) and 120.14(c) and           308               1                308           12           3,696
Total hours                       .................  ..............  ..............  ..............  360,930
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    Table 1 provides a breakdown of the total estimated annual 
recordkeeping burden. The estimates in this table have been reviewed by 
the agency's HACCP experts, who have practical experience in observing 
various processing operations and related recordkeeping activities.
    The burden estimates in table 1 are based on an estimate of the 
total number of juice manufacturing plants (i.e., 2,300) affected by 
the regulations. Included in this total are 850 plants currently 
identified in FDA's official establishment inventory plus 1,220 very 
small apple juice manufacturers and 230 very small orange juice 
manufacturers. The total burden hours are derived by estimating the 
number of plants affected by each portion of this final rule and 
multiplying the corresponding number by the number of records required 
annually and the hours needed to complete the record. These numbers 
were obtained from the agency's final regulatory impact analysis 
prepared for these regulations.
    Moreover, these estimates assume that every processor will prepare 
sanitary standard operating procedures and a HACCP plan and maintain 
the associated monitoring records and that every importer will require 
product safety specifications. In fact, there are likely to be some 
small number of juice processors that, based upon their hazard 
analysis, determine that they are not required to have a HACCP plan 
under these regulations.

    Dated: April 15, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-8996 Filed 4-20-04; 8:45 am]