SS-BSE Comment No.0910-0589 #2

RE: OMB Comment No. 0910-0589

SUPPORTING STATEMENT

Substances Prohibited from Use in Animal Food or Feed, 21 CFR Part 589

A. JUSTIFICATION

1. Circumstances Making the Information Collection Necessary

Section 701(a) (21 U.S.C. 371(a)) of the Federal Food, Drug, and Cosmetic Act (the act) gives us the authority to issue regulations for the efficient enforcement of the act. On June 5, l997, we issued a final rule which amended 21 CFR 589.2000 to provide that animal protein derived from mammalian tissue (with some exclusions) is not generally recognized as safe (GRAS) for use in ruminant feed, and is a food additive subject to certain provisions of the act. The rule placed general requirements on persons that manufacture, blend, process and distribute products that contain or may contain protein derived from mammalian tissue, and feeds made from such products.

We took this action because epidemiological evidence gathered in the United Kingdom suggested that bovine spongiform encephalopathy (BSE), a progressively degenerative central nervous system disease, is spread to ruminant animals by feeding protein derived from ruminants infected with BSE. While BSE had yet to be diagnosed in the United States, measures were necessary to prevent the establishment and amplification of this fatal disease in this country and thereby minimize any risk which might be faced by animals and humans.

In 2003, two cows tested positive for BSE, one in Canada and the other in the state of Washington. An epidemiological investigation and DNA test results confirmed that the Washington state cow was born and most likely became infected in Alberta, Canada, prior to Canada's 1997 implementation of a ban on feeding mammalian protein to ruminants. Several BSE positive cows were found in Canada from 2004-2006; in June of 2005, a 12-year-old beef cow, born and raised in Texas, tested positive for BSE. This was the first instance of BSE infection of a cow native to the United States.

The cases of BSE detected in Canada and the United States provide evidence of the risk of BSE in North America. The U.S. and Canadian feed bans implemented in 1997 were intended to address uncertainty about whether BSE was present in the cattle population of either country. While we continue to believe that compliance with the feed regulation has provided strong protection against the spread of BSE, the agency believes that the recent cases are an indication that additional animal feed protections are needed. Therefore, we believe that it was appropriate to propose certain additional measures in October 2005. More than 800 comments were received from industry, trade associations, government entities, and consumers. The final rule, which published April 25, 2008 (73 F.R. 22720), prohibits the use of certain cattle origin materials in the food or feed of all animals. These materials include the following: (1) the entire carcass of bovine spongiform encephalopathy (BSE)-positive cattle; (2) the brains and spinal cords from cattle 30 months of age and older; (3) the entire carcass of cattle not inspected and passed for human consumption that are 30 months of age or older from which brains and spinal cords were not removed; (4) tallow that is derived from BSE-positive cattle; (5) tallow that is derived from other materials prohibited by this rule that contains more than 0.15 percent insoluble impurities; and (6) mechanically separated beef that is derived from the materials prohibited by this rule. This is a request for OMB approval of the following information collection requirements:

21 CFR 589.2001 (c)(2)(ii) and (vi)- Recordkeeping – Requirement for renderers that

manufacture, process, blend or distribute cattle materials prohibited in animal feed or products that contain or may contain cattle materials prohibited in animal feed,

to maintain adequate written procedures specifying how they remove brain and spinal cord from cattle not inspected and passed for human consumption, or how they separate such animals based on whether or not they are 30 months of age or older. Renderers in this category must also maintain records sufficient to track cattle materials prohibited in

animal feed to ensure such material is not introduced into animal feed. Records are to

be made available for FDA inspection and copying, and are to be retained for a

minimum of 1 year.

21 CFR 589.2001 (c)(3)(i) – Recordkeeping – Requirement for renderers that manufacture, process, blend or distribute any cattle materials, to establish

and maintain records sufficient to demonstrate that material rendered for use in

animal feed was not manufactured from, processed with or does not otherwise

contain cattle materials prohibited in animal feed. For renderers that receive cattle materials from a supplier, such records would be considered sufficient if they include either 1) certification or other documentation from the supplier that material supplied to the renderer does not include CMPAF, provided that it includes a description of the segregation procedures used, documentation that the supplier confirms that its segregation procedures are in place prior to supplying any cattle material to the renderer, and records of the renderers periodic review of the suppliers’ certification or other documentation. Records are to be made available for FDA inspection and copying, and are to be retained for a minimum of 1 year.

21 CFR 589.2001(c)(3)( i ) ( A ) and ( B ) – Recordkeeping

Documentation of another method acceptable to FDA, such as third party certification,

for verifying that suppliers have effectively excluded CMPAF. Records are to be made available for FDA inspection and copying and are to be retained for a minimum of 1 year.

21 CFR 589.2001(b)(1) and 21 CFR 589.2001(f)—Reporting—New requirement that any foreign country seeking a designation from FDA that such country, due to a low BSE risk in that country, is not subject to the restrictions applicable to cattle materials prohibited in animal feed must submit a written request to the agency. The written request would have to include sufficient scientific evidence to support the claimed BSE risk status.

2. Purpose and Use of the Information

These records will be subject to inspection by Federal and State agencies to ensure that animal food or feed does not contain protein which may cause the spread of BSE in this country.

3. Use of Information Technology and Burden Reduction

The regulation does not specifically prescribe the use of automated, electronic, mechanical or other technological techniques or other forms of information technology as necessary for use by firms. Firms have the option of using information technology if they wish.

4. Efforts to Identify Duplication and Use of Similar Information

There are no other regulations or Federal agencies that require the development and maintenance of recordkeeping of this nature.

5. Impact on Small Business or Other Small Entities

The reporting & recordkeeping provisions are no more burdensome for small firms than for large. The regulations require all affected parties to maintain the same records. The recordkeeping requirements are based on the risk associated with the product.

6. Consequences of Collecting the Information Less Frequently

If there are no requirements for reporting and recordkeeping, the Agency will have limited means to monitor compliance. Without the ability to monitor compliance, the health of animals and the public may be put at risk.

7. Special Circumstances Relating to the Guideline of 5 CFR 1320.5

All of the reporting requirements are consistent with 5 CFR 1320.5.

8. Efforts to Obtain Comments on the Information Collection Before Submission to OMB.

We published a Proposed Rule with a 75-day notice in the Federal Register on October 6, 2005 (70 F.R. 58569), soliciting comments on the recordkeeping requirements placed on handlers of prohibited bovine material. In concurrence with this action, the agency submitted the information collection requests to OMB for review and approval. OMB did not approve the information collection request, but filed comment. No public comments regarding the proposed recordkeeping requirements were received by FDA.

9. Explanation of Any Payment or Gift to Respondents

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

10. Assurance of Confidentiality Provided to Respondent.

Confidentiality of information will be safeguarded within the provisions of FDA’s public information regulations in 21 CFR Part 20,

11. Justification for Sensitive Questions.

This information collection does not involve any questions of a sensitive nature.

12. Estimates of Hour Burden Including Annualized Hourly Cost..

The recordkeeping requirement in proposed § 589.2001(c)(2)(vi) will apply to the limited number of renderers who will handle prohibited bovine material. We estimate that no more than 50 of the approximately 175 rendering firms will be involved in the handling of this material. Although we may consider the distribution records needed to comply with this proposed regulation “usual and customary” and thus not subject to the PRA, we believe there will be burden associated with setting up a system to ensure such records are sufficient to address the proposed recordkeeping requirement. Likewise, although we may consider the records necessary to comply with proposed § 589.2001(c)(3)(i) as “usual and customary” and not subject to the PRA burden accounting, we are including a burden estimate to cover establishment of a system to ensure existing receipt and manufacturing records adequately address this proposed requirement.

There will be a one-time reporting burden to countries that apply to FDA seeking to be designated as not subject to the restrictions applicable to CMPAF (§ 589.2001(b)(1) and (§ 589.2001(f)); these provisions were added in the final rule. We estimate that each country that applies for an exclusion will spend 80 hours putting information together to submit to FDA. Table 1, row 1, of this document presents the one-time burden expected for countries that apply for the exclusion, and row 2 of the Table shows the recurring burden.

^{Table 1- Estimated Annual Reporting Burden¹}

21 CFR Section	No. of Respondents	No. of Responses per Respondent	Total Annual Responses	Hours per Response	Total Hours	Operation & Maintenance Cost
§589.2001(b) (1)2,	10	1	10	80	800	40,432³.
§589.2001(f)	10	1	10	26.4	264
Total burden					1,064	40,432

¹ There are no capital cost associated with this collection

²One time burden

³Combined O&M cost for §§ 589.2001(b)(1) & 589.2001(f)

Table 2 -. Estimated Annual Recordkeeping Burden ¹

21 CFR Section	Number of Record keepers	Annual Frequency per Record keeper	Total Annual Records	Hours per Record keeper	Total Hours	Operation and Maintenance Cost
589.2001(c)(2)(ii)and (vi) ; 589.2001(c)(3)(i) 589.2001(c)(2(ii) 589.2001(c)(3(i) (A) and (B)	175 50 175	1 1 1	175 50 175	20 20 26	3,500 1,000 4,550	$61,985 $17,710 $80,580
Total					9,050	$160,275

¹There are no capital cost associated with this burden

Estimated recordkeeping burden and operation and maintenance cost are derived from Agency resources and discussions with affected industry. The proposed rule would require additional measures be taken by renderers that handle CMPAF or products containing CMPAF to ensure that the prohibited materials are not used in animal feed. We believe that the proposed recordkeeping requirements would result in modest additional costs to all renderers as they would only require incremental administrative activities (to modify procedures and periodically review and file) beyond current renderer recordkeeping requirements. The estimated $61,985 is the result of 5 hours of quarterly review for a clerical worker, and 15 hours of initial modification of procedures for a clerical worker, both at $17.71/hour (adjusted for inflation since the 2005 proposed rule). This total of 20 hours at $17.71/hour for 175 facilities results in $61,985. It is estimated that 50 renderers will take advantage of the cattle aging option, resulting in a cost for these of $17,710. Compliance with the certification or documentation requirements for the 175 renderers is estimated to take 26 hours per record keeper, also at $17.71/hour, resulting in an estimated cost of $80,580. Total operation and maintenance costs are estimated at $160,275. We anticipate that records access costs would be negligible.

13. Estimate of Other Total Cost Burden to Respondents

As indicated in Table 1 above, this final rule adds a provision that allows a country to submit an application requesting a designation as not being subject to the new restrictions on the use of CMPAF. Using a total burden of 1,064 hours times the hourly wage of a compliance officer ($38)¹, the estimated cost is $40,432. As indicated in Table 2 above, the total estimated annual recordkeeping O & M costs for the rendering industry is $160,275 (9,050 hours times $17.71/hr.)

14. Annualized Cost to the Federal Government

The final rule may require the expenditure of additional funds by the Federal or State government, but the increased expenditures are not expected to be significant. The tissues that would be included on the list of cattle materials prohibited in animal feed, due to this final rule, may increase the number of inspections or the length of time necessary to inspect an establishment to verify compliance with the new requirements. However, the number of establishments inspected is not expected to substantially change as a result of this rule. All establishments that would be inspected for compliance under § 589.2001 would already be subject to §589.2000 or other federal rules.

However, the final rule will require some additional cost to the government for the review of the estimated 10 applications from foreign governments for country exclusion designation (Table 2 above). The estimated time for reviewing and evaluating these applications by FDA personnel is approximately 50 hours per application. Therefore, the cost to the Federal Government is estimated to be $25,000 (50 hours times $50/hour [GS-13, step 6] times 10 applications).

15. Explanation of Program Changes or Adjustments

New § 589.2001(c)(2(vi) provides requirements for renderers that handle cattle material prohibited in animal feed. It requires they establish and maintain records sufficient to track the prohibited materials to ensure such material is not introduced into animal feed, and make the records available for inspection and copying by the FDA. New §589.2001(b)(3)(i) requires that renderers that handle any cattle materials establish and maintain records sufficient to demonstrate that material rendered for use in animal feed was not manufactured from, processed with or does not otherwise contain cattle materials prohibited in animal feed and make copies of records available for inspection and copying by FDA.

16. Plans for Tabulation and Publication and Project Time Schedule

Not applicable.

17. Explain the reasons that display of the expiration date for OMB approval of the information collection would be inappropriate

Not applicable.

¹2006 National Industry-Specific Occupational Employment and Wage Estimates, US Department of Labor, Bureau of Labor Statistics (www.bls.gov/oes/current/naics4_325400.thm) $29.27 hourly wage plus 30% adjusted for benefits.