**SUPPORTING STATEMENT**

**HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) PROCEDURES FOR THE
SAFE AND SANITARY PROCESSING AND IMPORTING OF JUICE (FINAL RULE 21 CFR
PART 120).**

**A. Justification**

1\. **Necessity for Information Collection**

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 promulgate regulations for its efficient enforcement. The
agency also has authority under the Public Health Service Act (42 U.S.C.
264) to promulgate 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.

This final rule establishes Part 120 of Title 21 of [The Code of Federal
Regulations]{.underline}, which requires the use of Hazard Analysis
Critical Control Point (HACCP) methods by processors of fruit and
vegetable juices. HACCP is a system of preventive controls, which was
advocated by the President in his remarks on Food Safety Regulations on
October 2, 1997. 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 pre-planned sequence of operations and
observations (the HACCP plan) designed to avoid 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
act (21 U.S.C. 342).

The foundation of a HACCP system is the use of current good
manufacturing processes (CGMP\'s) and prerequisite program standard
operating procedures (SOP\'s). The hazard analysis and HACCP plan builds
on this foundation. By design, the HACCP method relies heavily on
monitoring the critical control points established in the HACCP plan,
and periodically recording the conditions at control points during the
processing operations leading to the finished product. These recorded
observations are necessary to verify adherence to the established
control conditions during the critical processing operations, and
thereby demonstrate that the finished food is safe. Information
development and record keeping are essential parts of any HACCP system.
The information collection requirements of this rule are narrowly
tailored to focus on the development of appropriate controls and
documenting those aspects of processing that are critical to food
safety. Through this final rule FDA is implementing its authority under
21 U.S.C. 342(a)(4). The information development and record keeping
requirements of this final rule are likewise an implementation of 21
U.S.C. 342 (a)(4).

Under the authority of section 704 of the act (21 U.S.C. 374), FDA
periodically inspects the facilities of, and collects samples from,
domestic food processors to determine whether food is prepared,
processed, and packaged in compliance with the adulteration (section
402), (21 U.S.C. 342 (a)(3) and (a)(4)), misbranding, and other
provisions of the act. FDA also inspects and samples foods imported to
the U.S. under the authority of section 801 of the act (21 U.S.C. 381).
Compliance of foods with the act and its derivative regulations can
often be established only by costly and statistically imperfect sampling
and laboratory testing of finished products for physical, chemical, or
microbial adulterants. HACCP procedures can largely eliminate the need
for extensive testing of finished products. HACCP procedures yield
products that are known, with a high degree of confidence, to be free of
the hazards controlled by the plan.

We request OMB approval of the following information collection
requirements.

**21 CFR 120.6(c), 120.12(a)(1)&(b):**

**Sanitation standard operating procedures (SSOP\'s)**

> Requires written SSOP\'s for sanitation controls, sanitation
> monitoring and correction. The SSOP\'s are signed and dated by the
> individual performing the operation.

**21 CFR 120.11(a)(1)(iv); 120.6(c); 120.12(a)(5)&(6):**

**Review of SSOP records**

> Requires that SSOP records be reviewed to determine whether control
> measures identified in the hazard analysis are being followed and
> signed and dated upon any modification or verification.

**21 CFR 120.7; 120.10(a); 120.12(a)(2), (b) and (c):**

**Hazard analysis**

> Requires a documented written hazard analysis of food hazards that are
> reasonably likely to occur for each type of food processed by the
> processor.

**21 CFR 120.8(a); 120.8(b)(7); 120.12(a)(3), (b) and (c):**

**Hazard Analysis Critical Control Point Plan**

> Sets forth requirements that every processor have a written HACCP plan
> when a hazard analysis reveals that a food hazard is reasonably likely
> to occur. Requires that plan be documented to signify its acceptance
> and implementation by the firm.

**21 CFR 120.8(b)(7) and 120.12(a)(4)(i) & (b):**

**Monitoring Critical Control Points**

> Requires a recordkeeping system that documents monitoring of the
> critical control points and other measurements as prescribed in the
> HACCP plan.

**21 CFR 120.11(b) and 120.12(a)(5)&(b):**

**Validation of the HACCP Plan**

> Sets forth requirements that every processor record the validation
> that the HACCP plan is adequate to control food hazards that are
> likely to occur.
>
> **21 CFR 120.11(a)(1)(iv); 120.11 (a)(2); and 120.12 (a)(5):**
>
> **Verification**
>
> Sets forth requirements that records be reviewed for completeness and
> that the records show that process monitoring instruments are properly
> calibrated and that end-product or in-process testing is performed in
> accordance with written procedures. Records are to be documented by
> the reviewer.
>
> **21 CFR 120.10(c)** **and 120.12(a)(4)(ii)&(b):**
>
> **Corrective Actions**
>
> Sets forth requirement that all actions taken in response to a
> deviation be documented.
>
> **21 CFR 120.11 and 120.12 (a)(5)&(b):**
>
> **Verification and Validation**
>
> Sets forth requirements for validation of the hazard analysis.
> Requires documentation of verification of HACCP system and validation
> of HACCP plan or hazard analysis.
>
> **21 CFR 120.14(a)(2):**
>
> **Application to Imported Products**
>
> Sets forth requirement 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
> this final rule except when the product is obtained from countries
> that have an active memorandum of understanding with the Food and Drug
> Administration that the inspection system of the foreign country is
> equivalent to that of the U.S.
>
> **21 CFR 120.24(a)(2):**
>
> **Process Control**
>
> Exempts producers of thermally treated shelf stable and concentrated
> products from the 5-log reduction requirement and associated
> recordkeeping requirements.
>
> **21 CFR 120.25:**
>
> **Process Verification for Certain Processors**
>
> Sets forth requirements for the analysis of the finished product for
> the presence of pathogens for processors that choose surface treatment
> of fruit in t he production of citrus juice products.

2\. **How, by Whom, and for What Purpose Information is Used**.

These regulations establish a requirement that processors of fruit and
vegetable juices apply HACCP principles to their processing operations.
The HACCP records include documentation of the implementation of the
SSOP\'s, the written hazard analysis, the HACCP plan, records
documenting verification of the HACCP system and validation of the HACCP
plan or hazard analysis, corrective actions, and contain data collected
at selected monitoring points (critical control points) during the
processing and packaging operations, as called for in a processor\'s
HACCP plan. The primary purpose of HACCP records is to permit a
processor to verify that products have been produced within carefully
established processing parameters (critical limits) that ensure that
hazards have been avoided. Monitoring 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.

The HACCP plan is validated periodically to demonstrate that it is
adequate to control food hazards. The HACCP plan is modified if the
validation reveals a need to do so. In the case that a processor has no
HACCP plan because a hazard analysis has revealed no food hazards, the
processor periodically reassesses the adequacy of that hazard analysis.
Such validation activities are essential to ensure that the HACCP system
is current.

HACCP places the burden of producing safe products and solving problems
squarely on the processor. A specific frequency of data collection is
not prescribed in the regulation. The schedule of critical control point
observations and recording of data (the frequency of collection) is
established by each processor according to factors such as the
variability of the process and the proximity of nominal processing
values to the control limits established in the HACCP plan. At a
minimum, each production lot would have associated HACCP and sanitation
records. To be effective, HACCP records must be available for all
production lots. When a HACCP program is implemented, it becomes an
integral part of the food production process.

Thus, a review of HACCP records, either by the processor or an FDA
inspector conducting a periodic establishment inspection, would allow a
determination of whether the HACCP system is up to date and whether any
current or previous production lot has deviated from control conditions
and may, as a result, present a public health hazard. These records
would be highly beneficial to both the processor and the agency to
expeditiously identify questionable production lots.

3\. **Use of Improved Information Technology**

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.
The agency estimates that about 25 percent of the responses would be
collected electronically.

Companies are free to use whatever forms of information technology may
best assist them in developing the proposed recordkeeping. FDA has 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\. **Identification of Duplication and Similar Information Already
Available**

The mandatory HACCP program represents a new regulatory approach.
However, some juice processors are using or are in the process of
implementing HACCP methods. In addition, processors of low-acid or
acidified juices are using HACCP methods. Except for the manufacturers
of low-acid canned foods, processors that do employ HACCP are not
currently required to make their HACCP records available to FDA
inspectors for examination.

There is no duplication of effort in this area. 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 this rulemaking. Moreover, juice processors
that currently process low-acid products under the provisions of 21 CFR
part 113 are using HACCP procedures and record keeping to avoid the
hazard of [Clostridium botulinum]{.underline} toxin that can result from
the improper thermal processing of low-acid canned food. These
processors are exempted (§§ 120.8 (c) and 120.24(a)(1)) from the HACCP
requirements of this rule that are controlled by the requirements of 21
CFR Parts 113 or 114. 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 this rule
that are 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 as 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 (120.8(e)).

5\. **Small Businesses**

FDA recognizes that a substantial proportion of juice processors
affected by this regulation is small businesses, and has kept their
particular needs in mind throughout the development of this rule. In
order to aid small businesses in the implementation of HACCP systems,
the proposed effective date for small businesses is extended for one
year beyond the effective date of the final rule, and for very small
businesses, two years beyond the proposed effective date of the final
rule. Small businesses would be assisted in accordance with the
provisions of the Small Business Regulatory Enforcement Fairness Act of
1996 \[Title II of Public Law 104-121 enacted March 29, 1996\].

6\. **Program Consequences if Less Frequent or No Collection**

The consequences of processors not collecting any or all HACCP
information (i.e., juice processors not maintaining HACCP records) would
prevent the adoption of a meaningful industry-wide HACCP program that
has been recommended by the National Advisory Committee on
Microbiological Criteria for Foods and sought by industry and consumer
advocates. The adoption of HACCP techniques and the associated record
keeping requirements are the most effective and efficient way for
government and industry to ensure food safety.

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. Records \"collection\" 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 can not be elective; it must continue from
day to day.

The agency 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**

The collection of HACCP information does not involve submission of
information to the agency, written responses to the agency, retention of
records for more than three years, the use of statistical methods,
pledges of confidentiality by FDA, or require the disclosure of trade
secrets or other confidential information.

8\. **Outside Consultation**

FDA published in the **Federal Register** of August 4, 1994 (59 FR
39888), an advance notice of proposed rulemaking (ANPRM) requesting
public comment about whether and how the agency should develop
regulations that would establish requirements for a new comprehensive
food safety assurance program based on HACCP. The agency received
approximately 150 comments in response to the ANPRM and applicable
issues from the comments are discussed in the proposed rule.

FDA held a public meeting on December 16 and 17, 1996, to solicit
comments from the juice industry and other interested entities. Comments
obtained from this meeting were discussed in the proposed rule.

In August, 1977, the National Center for Food Safety and Technology
(NCFST) and FDA held technical workshops in Illinois and Massachusetts
on current good manufacturing practices (CGMP\'s) for fresh juices.
Participants discussed how processors could reduce pathogen
contamination by practicing good sanitation techniques. Many small
businesses participated.

In November 1998, FDA held technical workshops in Florida and California
on how processors can obtain a 5-log reduction in the pertinent pathogen
in citrus juices. Many small businesses participated.

On May 12 & 13, 1999, NCFST and FDA held a symposium in Chicago on
\"Minimally Processed Fruits and Vegetable Juices: Scientific Issues to
Achieve a Safe Product\". Participants discussed how existing and new
technologies might be used to obtain a 5-log reduction of pertinent
pathogens. HACCP critical control points for fresh juice packaging,
juice storage and transportation were discussed. Many fresh juice
processors, an industry dominated by small businesses, participated.

On July 15 & 16, 1999, FDA held a workshop on food safety controls for
the apple cider industry. The workshop addressed pathogen reduction
interventions that may be effective for apple cider production and the
methods used to measure and validate such interventions. Many small
businesses attended.

On December 8 & 9, 1999, the National Advisory Committee on
Microbiological Criteria for Foods (NACMCF) held a public meeting to
discuss the new research and other information related to performance
criteria for fresh juices, specifically citrus juices. The agency
reopened the comment period for the juice HACCP proposal in order to
receive comment on the new data and other information.

The agency has made numerous public presentations to a wide variety of
groups, including small businesses, from September 1997 to the present
to educate the affected industry on the juice HACCP proposal.
Consequently, the juice industry has been able to openly discuss all
aspects of the proposed rule with FDA.

The agency also has an on-going Pilot Program with various segments of
the food industry, which is voluntarily performing HACCP-based
processing. General information gained from consultations with the
participants in the Pilot Program enabled FDA HACCP experts to make
informed estimates of the burdens associated with the proposed rule.

FDA published in the **Federal Register** of April 24, 1998 (64 FR
20450), the proposed rule to establish requirements relating to the
processing of juice and juice products (the HACCP proposal). At the same
time, FDA submitted the information requirements of this proposed rule
to OMB for review and approval. OMB deferred approval of these
information requirements until publication of the Final Rule, preferring
that FDA address all comments on the proposed information collection
burden at that time. FDA has addressed these concerns in the Final Rule.

9\. **Gifts**

This information collection does not provide for payment or gifts to
respondents.

10\. **Confidentiality**

Company records describing manufacturing procedures, which may be
consulted during FDA plant inspections, are subject to the
confidentiality guidelines in 21 CFR Part 20. HACCP records that the
agency may copy or take possession of would be treated as records that
are exempt from release under the provisions of the Freedom of
Information Act to the maximum extent permitted by that statute and FDA
regulations.

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.

11\. **Sensitive Questions**

There would be no questions of a personally sensitive nature associated
with the data collected. All records bear upon conditions under which a
food was processed and corrective actions taken upon the detection of
deviations from critical control point conditions.

12\. **Respondent Hour Burden and Annualized Burden Hour Cost
Estimates**

Table 1 sets forth an estimate of the annual hourly burden for
compliance with each section in part 120 that is associated with
collecting or recording information.

The time and costs of these activities will vary considerably among
processors depending on the type and number of products involved,
process details, and nature of the related equipment or instruments
required to monitor critical control points. Therefore the burdens have
been estimated using the typical small juice-processing firm as a model
because these firms represent a significant proportion of the industry.
However, the burden hours in Table 1, include only that portion of the
compliance burden that may be regarded as a new information collection
or recordkeeping requirement under this rule.

Thus, where an activity is required under existing regulations, its cost
is not considered as a new burden arising from this rule. For example,
the Current Good Manufacturing Practices provisions in 21 CFR part 110,
already require that all food processors ensure good sanitary practices
and conditions, monitor the quality of incoming materials, monitor and
control food temperatures to prevent bacterial growth, and perform
certain corrective actions and verification procedures. Consequently,
the burden hours that are reflected in Table 1 account only for the new
information collection and recording requirements under part 120.

There are an estimated 850 domestic producers of fruit and vegetable
juices. The model upon which these estimates are based is a producer
with 5 production lines that operate for 16 hours per day, 365 days per
year. The estimated number of critical control points per line per 8
hour shift is 5 and the frequency of monitoring and recording of results
is every 2 hours for each control point or 40 entries per 16 hour
production day. The time involved for the entry of data is 0.01 hours or
0.6 minutes per entry. The paperwork burden for monitoring the critical
control points is 850 producers x 40 entries per production day x 365
days per year x 0.01 hours per entry = 124,100 hours per year.

Additionally, the agency recognizes that the regulations will place a
paperwork burden on juice importers. In calendar year 1996, FDA records
show that 386 firms imported fruit or vegetable single strength juices,
juice blends, juice concentrates and/or purees that could be used in
juice production. It is estimated that 80 percent of the importers or
308 importers do business in juice products intended for inclusion in
juice beverages and that the remaining 20 percent are involved in other
food industries, such as bakeries, condiment and jams and jellies
manufacturers. FDA has estimated a burden for importers that includes
the time necessary for importers to develop a written verification plan,
verify compliance of imports, and to keep records of their verification
activities.

Juice processors include both large corporations producing a variety of
juices and very small businesses producing a single type of juice only
on a seasonal basis. Therefore, HACCP record keeping burdens will differ
widely among processors, depending on the size of the facility and
complexity of the HACCP control scheme (i.e., the number of products,
the number of process lines, the number of hazards controlled, and
number of production days); the frequency that control points are
monitored and values recorded; and also on the extent that data
recording time and cost are minimized by the use of automated data entry
technology.

> TABLE 1 - Estimated Annual Recordkeeping Burden^1^

+----------------------+----------+------+-------+-------+-----------+
| 21 CFR               | Number   | An   | Total | Hours | Total     |
|                      | of       | nual | A     | per   | Hours     |
|                      | Recor    | F    | nnual | R     |           |
|                      | dkeepers | requ |       | ecord |           |
|                      |          | ency | Re    |       |           |
|                      |          | of   | cords |       |           |
|                      |          | Rec  |       |       |           |
|                      |          | ords |       |       |           |
+----------------------+----------+------+-------+-------+-----------+
| 120.6(a)             | 1,875    | 1    | 1,875 | 4     | 7,500^2^  |
| &120.12(a)(1) & (b)  |          |      |       |       |           |
+----------------------+----------+------+-------+-------+-----------+
| 120.6(c) &           | 1,875    | 365  | 68    | 0.1   | 68,437.5  |
| 120.12(a)(1) & (b)   |          |      | 4,375 |       |           |
+----------------------+----------+------+-------+-------+-----------+
| 120.7; 120.10 (a); & | 2,300    | 1.1  | 2,530 | 20    | 50,600    |
| 120.12(a)(2), (b) &  |          |      |       |       |           |
| (c)                  |          |      |       |       |           |
+----------------------+----------+------+-------+-------+-----------+
| 120.8 (except        | 1,840    | 1    | 1,840 | 60    | 1         |
| monitoring records   |          |      |       |       | 10,400^2^ |
| required under       |          |      |       |       |           |
| 120.8(b)(7)); &      |          |      |       |       |           |
| 120.12(a)(3), (b)&   |          |      |       |       |           |
| (c)                  |          |      |       |       |           |
+----------------------+----------+------+-------+-------+-----------+
| 120.8(b)(7) &        | 1,450    | 14   | 21,17 | 0.01  | 211,700   |
| 120.12(a)(4)(i), &   |          | ,600 | 0,000 |       |           |
| (b)                  |          |      |       |       |           |
+----------------------+----------+------+-------+-------+-----------+
| 120.10(c) &          | 1,840    | 12   | 2     | 0.1   | 2,208     |
| 120.12(a)(4)(ii), &  |          |      | 2,080 |       |           |
| (b)                  |          |      |       |       |           |
+----------------------+----------+------+-------+-------+-----------+
| 120.11(a)(1)(iv);    | 1,840    | 52   | 9     | 0.1   | 9,568     |
| 120.11(a)(2);        |          |      | 5,680 |       |           |
| 120.12(a)(5)         |          |      |       |       |           |
+----------------------+----------+------+-------+-------+-----------+
| 120.11(b) &          | 1,840    | 1    | 1,840 | 4     | 7,360     |
| 120.12(a)(5), & (b)  |          |      |       |       |           |
+----------------------+----------+------+-------+-------+-----------+
| 120.11 (c) &         | 1,840    | 1    | 1,840 | 4     | 7,360     |
| 120.12(a)(5) & (b)   |          |      |       |       |           |
+----------------------+----------+------+-------+-------+-----------+
| 120.14(a)(2); &      | 308      | 1    | 308   | 4     | 1,232     |
| 120.14 (c) & (d)     |          |      |       |       |           |
+----------------------+----------+------+-------+-------+-----------+
| Totals: First year - |          |      |       |       |           |
| 476,365.5 Subsequent |          |      |       |       |           |
| years - 358,465.5    |          |      |       |       |           |
+----------------------+----------+------+-------+-------+-----------+

^1^ There are no capital costs or operating and maintenance costs
associated with this collection of information

^2^ First year only.

The burden estimates identified in Table 1 above are based on an
estimation of the total number of plants (i.e., 2300) affected by the
rule. Included in this total are 810 juice manufacturing plants
currently identified in FDA\'s Official Establishment Inventory (OEI)
plus 1220 very small apple juice manufacturers and 230 very small orange
juice manufacturers. Burden estimates are derived by estimating the
number of plants effected by each portion of the rule (not a constant of
2300 but a variable of each category) and multiplying the corresponding
number by the number of records required and the hours required to
complete the record. These numbers were obtained from the agency\'s
Final Regulatory Impact Analysis performed for this rule.

Moreover, these estimates assume that every processor will prepare
SSOP\'s and a HACCP plan and maintain the associated monitoring records
and that every importer will require product safety specifications.

Table 1 provides a breakdown of the total estimated recordkeeping burden
for the first year and subsequent years. The entries in this table have
been reviewed by the agency\'s HACCP experts, who have practical
experience in observing various processing operations and related record
keeping activities, and have been found to be reasonable estimates.

The total burden costs for the first year only approximate \$47 million
to \$61 million. The total

burden costs for subsequent years approximate \$24 million. Table 2
identifies these costs.

> [Cost to the Respondent]{.underline}
>
> The agency has identified a total of 850 U.S. processors that produce
> fruit and vegetable juices and estimates they will spend an average of
> 97,000 hours per year to keep HACCP and sanitation records after the
> first year.
>
> The annual hourly recordkeeping burden was calculated for all
> processors and the sum of these hours was divided by the total number
> of firms to yield an average annual hourly burden for each processor
> (97,000 hours/850 U.S. processors = 114 hours/U.S. processor). Hourly
> rates for workers involved in recordkeeping were estimated at
> approximately \$15.00 per hour.
>
> FDA records show that in 1996, 386 firms imported fruit and vegetable
> juices from other countries. The agency estimates 308 of these
> importers are supplying products to the juice industry and that this
> level of import activity will continue and that each importer will
> average 4 hours per year for a total recordkeeping time of 1,232
> hours.
>
> For processors:
>
> Total annual cost/respondent = \$15.00/hr x 114 hr = \$1,710
>
> For importers:
>
> Total annual cost/importer = \$15.00/hr x 4 hr = \$60

13. **Annual Cost Burden to Respondents**

> There are no capital costs or operating and maintenance costs
> associated with this collection of information.

14\. **Annualized Cost to the Federal Government.**

FDA estimates that the annualized cost to the Federal Government will be
minimal. It estimates

that the cost for the review and evaluation of the records generated
under this proposed rule will

not differ significantly from the annual expenditures for juice
processor inspections.

15\. **Changes of Adjustments in Burden**

This is a new collection

16\. **Statistical Analysis, Publication Plans and Schedule**

The agency has no plans for publication of information from this
information collection.

17\. **Approval Not to Display Expiration Date**

There are no reasons why display of the expiration date for OMB approval
of the information collection would be inappropriate.

18\. **Exception to the Certification Statement Identified in Item 19**.

No exceptions to the certification statement identified in Item 19 of
the instructions for completing OMB Form 83-I have been identified.

**B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS**

There are no plans to publish the information collected under the
provisions of this regulation for statistical use. The collection of
information required under the provisions of this regulation does not
employ statistical methods.

Table 2\--Total First Year and Recurring Burden Cost Per Activity

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

Activity First Year Costs Recurring Costs

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

Develop SOP\'s \$488,000

Prerequisite Program SOP\'s \$345,000

Monitoring and documenting for SOP\'s \$238,000 \$238,000

Hazard analysis \$575,000

HACCP plan \$1,380,000

Pesticide controls \$706,000 \$706,000

Pathogen controls \$21,400,000-\$35,660,000 \$8,210,000

Natural toxin controls \$104,000 104,000

Corrective action plan \$92,000

Corrective actions \$1,030,000 \$248,000

Verification \$959,000 \$959,000

Validation \$2,163,000 \$1,976,000

Process verification \$764,000 \$764,000

HACCP monitoring and

recordkeeping. \$2,596,000 \$2,596,000

Record maintenance

and storage. \$756,000 \$756,000

HACCP coordinator

training. \$2,990,000

Employee training \$722,000 \$722,000

Importers \$1,200,000 \$600,000

Foreign processors \$8,000,000 \$7,000,000

Totals \$47,000,000-\$61,000,000 \$25,000,000