69 FR 77 pgs. 21549-21551 - Agency Information Collection Activities; Submission for Office ofManagement and Budget Review; Comment Request; Hazard Analysis and CriticalControl Point; Procedures for the Safe and Sanitary Processing andImporting of Juice
Type: NOTICEVolume: 69Number: 77Pages: 21549 - 21551
Docket number: [Docket No. 2003N-0525]
FR document: [FR Doc. 04-8996 Filed 4-20-04; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0525]
Agency Information Collection Activities; Submission for Office ofManagement and Budget Review; Comment Request; Hazard Analysis and CriticalControl Point; Procedures for the Safe and Sanitary Processing andImporting of Juice
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) isannouncing that a proposed collection of information has been submitted tothe Office of Management and Budget (OMB) for review and clearance underthe Paperwork Reduction Act of 1995.
DATES:
Fax written comments on the collection ofinformation by May 21, 2004.
ADDRESSES:
OMB is still experiencing significant delaysin the regular mail, including first class and express mail, and messengerdeliveries are not being accepted. To ensure that comments on theinformation collection are received, OMB recommends that comments be faxedto the Office of Information and Regulatory Affairs, OMB, Attn: FumieYokota, Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins,Office of Management Programs (HFA-250), Food and DrugAdministration, 5600 Fishers Lane, Rockville, MD 20857,301-827-1223.
SUPPLEMENTARY INFORMATION:
In compliance with 44 U.S.C. 3507, FDA has submitted the followingproposed collection of information to OMB for review and clearance.
Hazard Analysis and Critical Control Point (HAACP); Procedures for theSafe and Sanitary Processing and Importing of Juice (OMB Control Number0910-0466)-Extension
These regulations mandate the application of HACCP procedures to fruitand vegetable juice processing. HACCP is a preventative system of hazardcontrol that can be used by all food processors to ensure the safety oftheir products to consumers. A HACCP system of preventive controls is themost effective and efficient way to ensure that these food products aresafe. FDA's mandate to ensure the safety of the nation's food supply isderived principally from the Federal Food, Drug, and Cosmetic Act (the act)(21 U.S.C. 321 et seq. ). Under the act, FDA has authority toensure that all foods in interstate commerce, or that have been shipped ininterstate commerce, are not contaminated or otherwise adulterated, areproduced and held under sanitary conditions, and are not misbranded ordeceptively packaged; under 21 U.S.C. 371, the act authorizes the agency toissue regulations for its efficient enforcement. The agency also hasauthority under the Public Health Service Act (42 U.S.C. 264) to issue andenforce regulations to prevent the introduction, transmission, or spread ofcommunicable diseases from one State to another other State. Informationdevelopment and recordkeeping are essential parts of any HACCP system. Theinformation collection requirements are narrowly tailored to focus on thedevelopment of appropriate controls and document those aspects ofprocessing that are critical to food safety. Through these regulations, FDAis 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 receivedone comment. The comment stated that the agency had underestimated theannual recordkeeping burden of the regulation. The comment identified thefollowing three sources of underestimated burden:
1. The comment stated that we underestimated the burden of validationrequired of importers in 21 CFR 120.14. We estimated the burden to be 4hours, whereas the comment said that validation requires 30 to 40 hours perimporter.
2. The comment stated that we underestimated the time required todocument the monitoring of critical control points (21 CFR 120.8(b)(7)). Weestimated 36 seconds; the comment said that 2 to 3 minutes is a betterestimate.
3. The comment stated that we underestimated the number of times perweek that processors verify records in accordance with 21 CFR 120.11. Weestimated once per week but, according to the comment, many processorsverify records more often. The comment said that some processors verifyrecords daily.
We have considered the three points raised in the comment. We willrevise the estimated burden in response to the first point, but we findthat the other two points do not require a revision of the estimatedburden. The following are our detailed responses:
1. Part of the difference between our estimated burden under 21 CFR120.14 and the estimate in the comment is that we computed burden perforeign source (308 entities) while the comment computes burden perimporter (120 entities). Our burden per importer for validation is about 10hours per year, which is still less than the comment's estimate but by asmaller order of magnitude. If foreign processors deal with multipleimporters, the comment's estimate of 30 to 40 hours per importer isplausible. We therefore adjust the last line in the table in response tothe comment. The hours per record change from 4 to 12 (column 5 of thetable), and the total burden changes from 1,232 to 3,696 hours (column 6 ofthe table). This total burden corresponds to a burden of about 30 hours perimporter.
2. The comment on documenting the monitoring of critical control pointsreflects some confusion about our calculation as presented in the burdentable. Our estimate of 0.6 minutes per record is an average based on ouroverall estimate of the amount of additional recordkeeping time per hourrequired by the rule (on average an additional 3 minutes per hour). Somerecords will require more time to keep and others less. The comment may becorrect 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 allrecords will require that amount of time. Furthermore, many firms arealready voluntarily performing a significant amount of the activitiesrequired to keep the records required by the rule to maintain good qualitycontrol to protect their brand value. Our estimate of the recordkeepingburden attributable to this rule is only for those additional activitiesthat firms have not been doing prior to the rule, but undertake to complywith the rule.
3. The verification burden under 21 CFR 120.11 is based on the number ofrecords that need to be verified. We say that each record must be verifiedwithin a week, so verification can be done weekly. But the burden is thesame if verification is done twice a week or daily because the number ofrecords to be verified is the same. So the burden would not change if weassumed more frequent verification.
FDA estimates the burden of this collection of information asfollows:
| 21 CFR Sections | No. of Recordkeepers | Annual Frequency of 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 | 68,438 |
| 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), 120.11 (a)(2), and120.12 (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) and 120.14(c) and (d) | 308 | 1 | 308 | 12 | 3,696 |
| Totalhours | 360,930 | ||||
| 1 There are no capital costs or operating and maintenancecosts associated with this collection of information. | |||||
Table 1 provides a breakdown of the total estimated annual recordkeepingburden. The estimates in this table have been reviewed by the agency'sHACCP experts, who have practical experience in observing variousprocessing operations and related recordkeeping activities.
The burden estimates in table 1 are based on an estimate of the totalnumber of juice manufacturing plants (i.e., 2,300) affected by theregulations. Included in this total are 850 plants currently identified inFDA's official establishment inventory plus 1,220 very small apple juicemanufacturers and 230 very small orange juice manufacturers. The totalburden hours are derived by estimating the number of plants affected byeach portion of this final rule and multiplying the corresponding number bythe number of records required annually and the hours needed to completethe record. These numbers were obtained from the agency's final regulatoryimpact analysis prepared for these regulations.
Moreover, these estimates assume that every processor will preparesanitary standard operating procedures and a HACCP plan and maintain theassociated monitoring records and that every importer will require productsafety specifications. In fact, there are likely to be some small number ofjuice processors that, based upon their hazard analysis, determine thatthey 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]
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