0466 Juice HACCP SSA 2020 Ext

UNITED STATES FOOD AND DRUG ADMINISTRATION
Hazard Analysis and Critical Control Point (HACCP) Procedures
for the Safe and Sanitary Processing and Importing of Juice
OMB Control No. 0910-0466

SUPPORTING STATEMENT – Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA, the agency, us or we)
regulations in part 120 (21 CFR part 120) which mandate the application of hazard analysis and
critical control point (HACCP) principles to the processing of fruit and vegetable juices.
HACCP is a preventive system of hazard control designed to help ensure the safety of foods.
The regulations were issued under FDA's statutory authority to regulate food safety under section
402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 342(a)(4)).
Under section 402(a)(4) of the FD&C Act, a food is adulterated if it is prepared, packed, or held
under insanitary conditions whereby it may have been contaminated with filth or rendered
injurious to health. The agency also has authority under section 361 of 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, territory or possession to another, or from
outside the United States into this country. Under section 701(a) of the FD&C Act (21 U.S.C.
371(a)), FDA is authorized to issue regulations for the efficient enforcement of that Act.
The rationale in establishing a HACCP system of preventive controls is to design and check the
process so that the final product is not contaminated - not test for contamination after it may have
taken place. Under HACCP, processors of fruit and vegetable juices establish and follow a preplanned sequence of operations and observations (the HACCP plan) designed to avoid or
eliminate one or more specific food hazards, and thereby ensure that their products are safe,
wholesome, and not adulterated; in compliance with section 402 of the FD&C Act (21 U.S.C.
342). 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.
We therefore request extension of OMB approval of the provisions found in 21 CFR part 120 as
discussed in this supporting statement.
2. Purpose and Use of the Information Collection
HACCP records are normally reviewed by appropriately trained employees at the end of a
production lot or at the end of a day or week of production to verify that control limits have been
maintained, or that appropriate corrective actions were taken if the critical limits were not
maintained. Such verification activities are essential to ensure that the HACCP system is
working as planned. A review of these records during the conduct of periodic plant
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also permits FDA to determine whether the products have been consistently processed in
conformance with appropriate HACCP food safety controls.
This information collection supports section 120.14, which requires that importers of juice take
affirmative steps and maintain records that verify that the juice they offer for import into the
United States were processed in accordance with the HACCP and sanitation provisions set forth
in part 120. These records are also available for review by FDA.
Description of Respondents: Respondents to this information collection are processors of fruit
and vegetable juices. Respondents are from the private sector (for-profit businesses).
3. Use of Improved Information Technology and Burden Reduction
Many of the observations required to document HACCP control point parameters (times,
temperatures, acidity, etc.) are amenable to modern data acquisition and processing technology.
The agency encourages the application of this technology for monitoring and recordkeeping
operations to minimize the paperwork burden and labor costs, and also to enhance the
organization of records and to facilitate their retrieval. We estimate that 95 percent (95%) of the
responses would be collected electronically.
Companies are free to use whatever forms of information technology may best assist them in
recordkeeping. We have made this clear in the records provisions of this regulation (§ 120.12
(g)), which states that records maintained as computer files are acceptable when controls are
implemented to ensure the integrity of the electronic data and signatures.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection. Juice processors that currently use
HACCP methods, voluntarily or in accord with State or other federal regulations, are likely to
already meet specific hazard avoidance and record keeping requirements, because maintaining
records of control point observations is a necessary component of the HACCP method, and not
unique to these regulations. Moreover, juice processors that currently process low-acid products
under the provisions of 21 CFR part 113, or acidified products under the provisions of 21 CFR
part 114 are using HACCP based procedures and recordkeeping to avoid the hazard of
Clostridium botulinum toxin that can result from the improper thermal processing of low-acid
and acidified canned foods. These processors are exempted (§§ 120.7(e) and 120.24(a)(1)) from
the HACCP requirements of these regulations that are addressed by the requirements of 21 CFR
parts 113 or 114. In addition, juice processors using a single thermal processing step sufficient
to achieve shelf-stability of the juice or a thermal concentration process that includes thermal
treatment of all ingredients are also exempted (§ 120.24(a)(2)) from the requirements of these
regulations that address hazards controlled by such thermal processes provided that these
processors include a copy of the thermal process used to achieve shelf stability or concentration
in their written hazard analysis required by § 120.7. Finally, processors do not need to include in
their HACCP plans food hazards that are adequately controlled by a previous processor

5. Impact on Small Businesses or Other Small Entities
We estimate that a substantial proportion (75%) of juice processors affected by the regulation are
small businesses, however we do not believe the information collection poses undue burden on
these entities. At the same time, we aid small businesses in complying with the juice HACCP
requirements through our Regional Small Business Representatives and through administrative
and scientific staffs within the agency. We also provide a Small Business Guide on our website
at https://www.fda.gov/industry/small-business-assistance, as well as a Juice HACCP Small
Entity Compliance Guide at https://www.fda.gov/food/hazard-analysis-critical-control-pointhaccp/juice-haccp.
6. Consequences of Collecting the Information Less Frequently
Data collection occurs daily. Under a HACCP scheme, the frequency of data collection by each
processor would occur periodically during daily food processing operations, but that frequency
of observation and recording would vary considerably for different processors, depending on the
nature and number of the hazards controlled under a HACCP plan. Recordkeeping must be
continuous once a HACCP plan has been implemented. HACCP has little value if used on a
part-time basis, particularly in the context of a regulatory program. In that sense, the "frequency
of reporting," that is, the periodic recording and maintaining records of control point
observations and related HACCP activities cannot be elective; it must continue from day to day.
FDA would not collect HACCP records or plans as a routine matter. HACCP records would
remain on file at each processing facility and would be examined there periodically by the
agency to determine, for example, whether a processor is practicing preventive control measures
that are consistent with the hazards presented by fruit and vegetables juices. HACCP plans and
records would document that the appropriate HACCP control measures are applied and have
been used for all production lots. Finally, the records would establish that the firm is
continuously producing safe juices that are in compliance with the provisions of the FD&C Act.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances associated with this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), we published a 60-day notice for public comment in the
Federal Register of September 26, 2019 (84 FR 50852). We received no comments.
9. Explanation of Any Payment or Gift to Respondents
There are no incentives, payments or gifts associated with this information collection.

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10. Assurance of Confidentiality Provided to Respondents
Company records describing manufacturing procedures, which may be reviewed during FDA
plant inspections, and HACCP records that the agency may copy often contain trade secret and
commercial confidential information. Confidential commercial information is protected from
disclosure under the Freedom of Information Act (FOIA) under sections 552(a) and (b) (5 U.S.C.
552(a) and (b)), by Section 301(j) of the Act, and by part 20 of our regulations (21 CFR part 20).
The agency would attempt to maintain an equitable position consistent with its disclosure
regulations and the public interest. Thus, § 120.12(f)(1) states that HACCP plans and records
required by part 120 are not available for public disclosure unless they have been previously
disclosed, and that HACCP records may be subject to the discretionary disclosure provisions of
§20.81 to the extent that they contain materials that are otherwise publicly available or could not
reasonably be expected to cause a competitive hardship if revealed.
This information collection request (ICR) requires the respondent to collect personally
identifiable information (PII) or other data of a personal nature to be used for events such as an
inspection by FDA staff. The respondent will collect information to provide records of
evaluation. PII which is collected is the signature or initials of the person performing the
operation or creating the record required under 21 CFR 120 (see 21 CFR 120.12(b)(3)). The
signature of the most responsible individual onsite at the processing facility or by a higher-level
official of the processor for written hazard analysis and written HACCP plan is also collected by
the respondent (see 21 CFR 120.12(c)). The PII maintained by the respondent is collected in the
context of the individual’s professional capacity. Regulations in section 120 mandate the
application of hazard analysis and critical control point (HACCP) principles to the processing of
fruit and vegetable juices. HACCP is a preventive system of hazard control designed to help
ensure the safety of foods. All information collected by the respondent is stored at the facility
and viewed during inspection, and if there is an issue, the information will be sent to the FDA for
further review.
We determined that although PII is collected, this collection is not subject to the Privacy Act of
1974 and the particular notice and other requirements of the Act do not apply. Specifically, we
do not use name or any other personal identifier to routinely retrieve records from the
information collected.
In preparing this supporting statement, we consulted our Privacy Office to ensure appropriate
handling of information collected.
11. Justification for Sensitive Questions
The information collection does not involve sensitive questions.

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12. Estimates of Annualized Burden Hours and Cost
12a. Annualized Hour Burden Estimate
We estimate the burden of this collection of information as follows:
Table 1.--Estimated Annual Recordkeeping Burden
21 CFR Section; Activity

No. of
Recordkeepers

No. of
Records per
Recordkeeper

Total
Annual
Records

Average
Burden per
Record

Total
Hours

120.6(c) and 120.12(a)(1) and (b);
Require written monitoring and
correction records for Sanitation
Standard Operating Procedures
(SSOP’s).

1,875

365

684,375

0.1
(6 min.)

68,438

120.7; and 120.12(a)(2), (b) and (c);
Require written hazard analysis of
food hazards.

2,300

1.1

2,530

20

50,600

120.8(b)(7) and 120.12(a)(4)(i) and
(b);
Require a recordkeeping system that
documents monitoring of the critical
control points and other measurements
as prescribed in the HACCP plan.
120.10(a), 120.10(c) and
120.12(a)(4)(ii) and (b); Set forth
requirements for written corrective
action plans when such plans are
included in a HACCP plan and require
that all corrective actions taken in
response to a deviation from a critical
limit be documented.
120.11(a)(1)(iv) and (a)(2), and 120.12
(a)(5) and (b);
Require records showing that process
monitoring instruments are properly
calibrated and that end-product or inprocess testing is performed in
accordance with written procedures.
120.11(b) and (c); and 120.12(a)(5)
and (b); Require that every processor
record the validation that the HACCP
plan is adequate to control food
hazards that are likely to occur.

1,450

14,600

21,170,000

0.01
(1 min.)

211,700

1,840

12

22,080

0.1
(6 min.)

2,208

1,840

52

95,680

0.1
(6 min.)

9,568

1,840

1

1,840

4

7,360

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21 CFR Section; Activity

No. of
Recordkeepers

No. of
Records per
Recordkeeper

Total
Annual
Records

Average
Burden per
Record

Total
Hours

120.11(c) and 120.12(a)(5) and (b);
Require documentation of revalidation
of the hazard analysis upon any
changes that might affect the original
hazard analysis (applies when a firm
does not have a HACCP plan because
the original hazard analysis did not
reveal hazards likely to occur.

1,840

1

1,840

4

7,360

120.14(a)(2), (c), and (d) and
120.12(b); Require that importers of
fruit or vegetable juices, or their
products used as ingredients in
beverages, have written procedures to
ensure that the food is processed in
accordance with our regulations in part
120.

308

1

308

4

1,232

1,560

1.1

1,716

60

102,960

120.8(a), 120.8(b), and 120.12(a)(3),
(b) and (c);
Require written HACCP plan.
Total

461,426

Table 1 provides our estimate of the total annual recordkeeping burden of our regulations in part
120. We base our estimate of the average burden per recordkeeping on our experience with the
application of HACCP principles in food processing. We base our estimate of the number of
recordkeepers on our estimate of the total number of juice manufacturing plants affected by the
regulations (plants identified in our official establishment inventory plus very small apple juice
and very small orange juice manufacturers). These estimates assume that every processor will
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.
12b. Annualized Cost Burden Estimate
We estimate that the average hourly wage for respondents’ workers involved in recordkeeping is
equivalent to a GS-5/Step 1 rate in the locality pay area of Washington-Baltimore in 2019,
approximately $18.19/hour. Doubling this wage to account for overhead costs, we assume the
average hourly cost to respondents to be $36.38/hour. The overall estimated cost incurred by the
respondents is $16,786,677.88 (461,426 burden hours x $36.38/hr. = $16,786,677.88).
Type of Respondent
Hourly Wage Worker

Total Burden
Hours
461,426

Hourly Wage Rate
$36.38

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Total Respondent
Costs
$16,786,677.88

13. Estimates of Other Total Annual Costs to Respondents/Recordkeepers or Capital Costs
There are no capital, start-up, operating, or maintenance costs associated with this collection.
14. Annualized Cost to the Federal Government
Our review of the retained records would generally occur as part of its routine or for cause
establishment inspection activities. We estimate that our review of the retained records would
take five hours per inspection. We estimate the hourly cost for review and evaluation to be
$47.52 per hour, the GS-13/Step-1 rate for the Washington-Baltimore locality pay area for the
year 2019. To account for overhead, this cost is increased by 100 percent, making the total cost
$95.04 per hour. Thus, we estimate the cost to the Federal Government for the review of records
to be $475.20 per review ($95.04/hour x 5 hours). We estimate that we review records for an
average of 100 inspections per year. Thus, we estimate that the total annual cost to the Federal
Government would be $47,520 ($475.20 x 100 inspections).
15. Explanation for Program Changes or Adjustments
The burden for this collection of information has remained unchanged since the last review of
this information collection.
16. Plans for Tabulation and Publication and Project Time Schedule
This information collected will not be published or tabulated.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
There are no reasons why display of the expiration date for OMB approval of the information
collection would be inappropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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