SUPPORTING STATEMENT
1. Circumstances
Making the Collection of Information Necessary
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.
The “Hazard Analysis and Critical Control Point (HACCP); Procedures for the Safe and Sanitary Processing and Importing of Juice” regulations establish Part 120 of Title 21 of The Code of Federal Regulations, which requires the use of (HACCP) methods by processors of fruit and vegetable juices. HACCP is a system of preventive controls, which was advocated by President Clinton 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 (CGMPs) and prerequisite program standard operating procedures (SOPs). 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 these regulations are narrowly tailored to focus on the development of appropriate controls and documenting those aspects of processing that are critical to food safety. Through these regulations, FDA is implementing its authority under 21 U.S.C. 342(a)(4). The information development and record keeping requirements of these regulations 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 SSOPs for sanitation controls, sanitation monitoring and correction. The SSOPs 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 these regulations 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. Purpose
and Use of the Information Collection
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 SSOPs, 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.
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. The agency estimates that about 25
percent (25%) 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. Efforts
to Identify Duplication and Use of Similar Information
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 these regulations. 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 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 these regulations
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 these
regulations 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. Impact
on Small Businesses or Other Small Entities
FDA
estimates that a substantial proportion (75%) of juice processors
affected by this regulation are small businesses, and has kept their
particular needs in mind throughout the development of these
regulations. In order to aid small businesses in the implementation
of HACCP systems, the proposed effective date for small businesses
was extended for one year beyond the effective date of the
regulations, and for very small businesses, two years beyond the
proposed effective date of the regulations. FDA
aids small businesses in complying with the juice HACCP requirements
through the agency’s Regional Small Business Representatives
and through the administrative and scientific staffs within the
Agency. FDA has provided a Small Business Guide on the agency’s
website at http://www.fda.gov/oc/industry/.
6. Consequences
of Collecting the Information Less Frequently
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.
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. 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 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), FDA published a 60-day notice for
public comment in the Federal Register of July 14, 2010 (75 FR
40839). FDA received no comments.
12. Estimates
of Annualized Burden Hours and Costs
12
a. Annualized Hour Burden Estimate
FDA estimates the burden of this collection of information as follows:
Table 1.--Estimated Annual Recordkeeping Burden 1
21 CFR Section |
No. of Recordkeepers |
Annual Frequency per Recordkeeping |
Total Annual Records |
Hours per Record |
Total Hours |
120.6(c) and 120.12(a)(1) and (b) |
1,875 |
365 |
684,375 |
0.1 |
68,437.5 |
120.7; 120.10(a); and 120.12(a)(2), (b) and (c) |
2,300 |
1.1 |
2,530 |
20 |
50,600 |
120.8(b)(7) and 120.12(a)(4)(i) and (b) |
1,450 |
14,600 |
21,170,000 |
0.01 |
211,700 |
120.10(c) and 120.12(a)(4)(ii) and (b) |
1,840
|
12 |
22,080 |
0.1 |
2,208 |
120.11(a)(1)(iv) and (a)(2) and 120.12 (a)(5) |
1,840 |
52 |
95,680 |
0.1 |
9,568 |
120.11(b) and 120.12(a)(5) and (b) |
1,840 |
1 |
1,840 |
4 |
7,360 |
120.11(c) and 120.12(a)(5) and (b) |
1,840 |
1 |
1,840 |
4 |
7,360 |
120.14(a)(2), (c), and (d) |
308 |
1 |
308 |
4 |
1,232 |
Total |
|
|
|
|
358,466 |
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. FDA bases this hour burden estimate on its experience with the application of HACCP principles in food processing.
The burden estimates in table 1 of this document 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.
12 b. Annualized Cost Burden Estimate
FDA estimates that the average hourly wage for respondents’ workers involved in recordkeeping is equivalent to a GS-5-1 level in the locality pay area of Washington-Baltimore in 2010, approximately $16.33/hour. Doubling this wage to account for overhead costs, FDA estimates the average hourly cost to respondents to be $32.66/hour. The overall estimated cost incurred by the respondents is $11,707,500 (358,466 burden hours x $32.66/hr = $11,707,500).
13. Estimates of Other
Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There
are no capital,
start-up, operating, or maintenance costs associated
with this collection.
14. Annualized
Cost to the
Federal Government
FDA’s
review of the retained records would generally occur as part of its
routine or for cause establishment inspection activities. FDA
estimates that its review of the retained records would take five
hours per inspection. FDA estimates the hourly cost for review and
evaluation to be $42.66 per hour, the GS-13/Step-1 rate for the
Washington-Baltimore locality pay area for the year 2010. To account
for overhead, this cost is increased by 100 percent, making the total
cost $85.32 per hour. Thus, FDA estimates the cost to the Federal
Government for the review of records to be $426.60 per review
($85.32/hour x 5 hours). FDA estimates that it reviews records for
an average of 100 inspections per year. Thus, FDA estimates that the
total annual cost to the Federal Government would be $42,660 ($426.60
x 100 inspections).
15. Explanation
for Program Changes or Adjustments
The
burden has not changed from the burden shown in the current
inventory.
16. Plans for Tabulation and Publication and Project Time Schedule
The
agency has no plans for publication of information from this
information collection.
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.
| File Type | application/msword |
| File Title | Supporting Statement for |
| Author | Joanna Capezzuto |
| Last Modified By | DPresley |
| File Modified | 2010-09-24 |
| File Created | 2010-09-24 |