Prevention of Salmonella Enteritidis in Shell Eggs During Production---Recordkeeping and Registration Provisions

Forms and Documents

Document Name	Status
Form FDA - 3733 Reporting Producer Registration Form	New
shell eggs--summary of comments 7-15-09.doc Supplementary Document	2009-07-15
shell eggs revised ss 5-4-2010.doc Supporting Statement A	2010-05-04

IC Document Collections

IC ID	Document Title	Status
192701	Egg Testing	New
192698	Environmental Testing	New
190258	Reporting Producer Registration Form	New
190257	Prevention Plan Review and Modification	New
190255	Testing, Diversion, amd Treatment (Negative)	New
190254	Testing, Diversion or Treatment (Positive)	New
190251	Refrigeration Records	New
190250	Cleaning and Disinfection Records	New
190248	Rodent and Other Pest Control and Biosecurity Records	New
190247	Chick and Pullet Procurement Records	New
190246	Prevention Plan Design	New

ICR Details

OMB Control No: 0910-0660	ICR Reference No: 200908-0910-004
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Prevention of Salmonella Enteritidis in Shell Eggs During Production---Recordkeeping and Registration Provisions
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 05/06/2010
	Date Received in OIRA: 08/10/2009
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2013	36 Months From Approved
Responses	805,796	0	0
Time Burden (Hours)	406,750	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Shell eggs contaminated with Salmonella Enteritidis (SE) are responsible for more than 140,000 illnesses per year. The Food and Drug Administration (FDA) is requiring each farm site with 3,000 or more egg laying hens that sells raw shell eggs to the table egg market, other than directly to the consumer, and does not have all of the shell eggs treated, to design and monitor an SE prevention plan. In addition, all farms covered by any part of the rule are required to register with FDA. We have concluded that recordkeeping and registration are necessary for the success of the SE prevention measures. Written SE prevention plans and records of actions taken due to each provision are essential for farms to implement SE prevention plans effectively. Further, they are essential for FDA to be able to determine compliance. The Public Health Service Act (PHS Act) authorizes the Secretary to make and enforce such regulations as "are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States * * * or from one State * * * into any other State" (section 361(a) of the PHS Act). This authority has been delegated to the Commissioner of Food and Drugs. Under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 342(a)(4)), 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. Under section 701(a) of the act (21 U.S.C. 371(a)), FDA is authorized to issue regulations for the efficient enforcement of the act.

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Authorizing Statute(s): US Code: 21 USC 342 Name of Law: FFDCA
   US Code: 21 USC 371 Name of Law: FFDCA
  

Citations for New Statutory Requirements: US Code: 21 USC 371 Name of Law: FFDCA

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AC14	Final or interim final rulemaking	74 FR 33030	07/09/2009

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 11

IC Title	Form No.	Form Name
Prevention Plan Design
Chick and Pullet Procurement Records
Rodent and Other Pest Control and Biosecurity Records
Cleaning and Disinfection Records
Refrigeration Records
Testing, Diversion or Treatment (Positive)
Testing, Diversion, amd Treatment (Negative)
Prevention Plan Review and Modification
Reporting Producer Registration	FDA - 3733	DHHS/FDA SHELL EGG PRODUCER REGISTRATION
Egg Testing
Environmental Testing

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	805,796	0	0	805,796	0	0
Annual Time Burden (Hours)	406,750	0	0	406,750	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new collection requirement. The increase in reporting and recordkeeping burdens reflect our estimate of the number of registrations that would be required by the final rule and the amount of recordkeeping associated with the SE prevention plans required by the final rule.

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Annual Cost to Federal Government: $116,615

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 08/10/2009

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