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###### Department of Agriculture

###### Food Safety and Inspection Service 

          - [Docket No. FSIS 2007-0018] 

# AGENCY:

Food Safety and Inspection Service (FSIS), USDA. 

# ACTION:

Notice and request for comments. 

# SUMMARY:

The Food Safety and Inspection Service (FSIS) is publishing this notice to articulate its position on the slaughter for human food of hogs and chickens from farms identified as having purchased or otherwise received pet food scraps that contain melamine and melamine-related compounds. The contaminated pet food scraps were used to supplement animal feed on farms in several States. The results of an interim safety/risk assessment indicate that, based on currently available data and information, the consumption of pork, poultry, eggs, and domestic fish products from animals inadvertently fed animal feed contaminated with melamine and melamine-related compounds is very unlikely to pose a human health risk. 

Based on the findings of the interim safety/risk assessment, as well as the results of validated testing for melamine concentration that has been conducted on tissue samples of hogs and chickens exposed to the adulterated feed, FSIS has determined that pork and poultry products from all animals identified as having been fed animal feed containing contaminated pet food scraps are “not adulterated” and are thus eligible to receive the mark of inspection. All such animals that were being held on farms have been released and may be offered for slaughter for human food. 

# DATES:

                        Comments on this                         **Federal Register**                         notice must be received by August 28, 2007.                     

# ADDRESSES:

FSIS invites interested persons to submit comments on the findings in this notice. Comments may be submitted by any of the following methods: 
      - Federal eRulemaking Portal: This Web site provides the ability to type short comments directly into the comment field on this Web page or attach a file for lengthier comments. Go to http://www.regulations.gov                          and, in the “Search for Open Regulations” box, select “Food Safety and Inspection Service” from the agency drop-down menu, then click on “Submit.” In the Docket ID column, select FDMS Docket Number FSIS-2007-0018 to submit or view public comments and to view supporting and related materials available electronically.                     
      - Mail, including floppy disks or CD-ROM's, and hand-or courier-delivered items: Send to Docket Clerk, U.S. Department of Agriculture, Food Safety and Inspection Service, 300 12th Street, SW., Room 102 Cotton Annex, Washington, DC 20250.
      - Electronic mail: fsis.regulationscomments@fsis.usda.gov. 

                        Individuals who do not wish FSIS to post their personal contact information — mailing address, e-mail address, telephone number — on the Internet may leave the information off their comments. All submissions received by mail or electronic mail must include the Agency name and docket number FSIS-2007-0018. All comments submitted in response to this notice, as well as research and background information used by FSIS in developing this document, will be available for public inspection in the FSIS Docket Room at the address listed above between 8:30 a.m. and 4:30 p.m., Monday through Friday. Comments will also be posted on the Agency's Web site at                         *http://www.fsis.usda.gov/​*.                     

# FOR FURTHER INFORMATION CONTACT:

                        Dr. Daniel Engeljohn, Deputy Assistant                               ( print page 29946)                            Administrator, Office of Policy, Program, and Employee Development (OPPED), (202) 205-0495.                     

# SUPPLEMENTARY INFORMATION:

 

## Background 

                    FSIS is responsible for ensuring that meat and poultry products are safe, wholesome, and accurately labeled. FSIS enforces the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601*et seq.*) and the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451*et seq.*). These two statutes require Federal inspection and provide for Federal regulation of meat and poultry products prepared for distribution in commerce for use as human food.                 

Under the Acts, FSIS inspection personnel apply the mark of inspection to meat and poultry products if they find upon inspection that these articles are not adulterated (21 U.S.C. 455, 457; 21 U.S.C. 604, 606, 607). The Acts prohibit the sale or transportation in commerce of meat and poultry products capable of use as human food that are adulterated or misbranded or that have not been inspected and passed (21 U.S.C. 458 (a)(2); 21 U.S.C. 610(c)). The Acts also authorize FSIS to take certain actions to remove from commerce meat or poultry products that the Agency has reason to believe are adulterated or misbranded, or that have not been inspected (21 U.S.C. 467(a),467(b); 21 U.S.C. 672,673). Under the Acts, a meat or poultry product is adulterated if, among other circumstances, it bears or contains any poisonous or deleterious substance that may render it injurious to health (21 U.S.C. 453(g)(1), 601(m)(1)); it bears or contains (by reason of administration of any substance to the live animal or poultry, or otherwise) any added poisonous or added deleterious substance which may in the judgment of the Secretary render it unfit for human food (21 U.S.C. 453(g)(2), 601(m)(2)); if it is for any reason unsound, unhealthful, unwholesome, or unfit for human food (21 U.S.C. 453(g)(3), 601(m)(3)); or if it has been prepared, packaged, or held under insanitary conditions whereby it may have been rendered injurious to health (21 U.S.C. 453(g)(4), 601(m)(4)). 

On April 26, 2007, FSIS and the U.S. Food and Drug Administration (FDA) announced that hogs on farms in certain States had consumed animal feed supplemented with pet food scraps contaminated with melamine and melamine-related compounds. On April 30, 2007, the agencies announced that chickens on certain farms in Indiana had also been fed poultry feed supplemented with melamine-contaminated pet food scraps. FSIS learned of the adulterated feed during the course of an ongoing FDA investigation of pet food associated with illnesses and deaths in cats and dogs. The pet food was found to contain melamine or melamine-related compounds (cyanuric acid, ammelide, and ammeline). 

Based on the available science and information, FDA investigators believed that the combination of melamine and melamine-related compounds, particularly cyanuric acid, caused the formation of crystals in the kidneys that led to kidney failure in some of the pets that had consumed the adulterated pet food. The investigation found that the source of the melamine and melamine-related compounds in the pet food was products, labeled as rice protein concentrate and as wheat gluten, which had been imported from China. The investigation also revealed that scraps from the adulterated pet food had been sold to hog and chicken producers and feed mills, where they were used to supplement animal feed. FDA then notified FSIS of its findings regarding animal feed. 

When FSIS and FDA announced that they had learned that hog and chicken farms in various States had purchased or otherwise received pet food scraps contaminated with melamine and melamine-related compounds, the agencies noted that some of the hogs and chickens that had consumed feed supplemented with the contaminated pet food scraps may have been slaughtered and their products distributed in commerce. At that time, the agencies also explained that they would work with States and industry to take the appropriate action with regard to the disposition of these products. 

### Actions Taken Based on Data Concerning the Consumption of Feed Supplemented With Adulterated Pet Food 

When FSIS learned that hogs and chickens had consumed feed that had been supplemented with pet food scraps contaminated with melamine and melamine-related compounds, the Agency concluded that risk to human health from consuming pork or poultry products from these animals was likely to be very low. This conclusion was based on information that indicated that the concentration of melamine and melamine-related compounds in the adulterated feed was likely very low due to dilution. However, because the animal feed in question was adulterated, and given the information that was available at the time, FSIS could not rule out the possibility that pork and poultry products produced from hogs and chickens that consumed the adulterated feed could also be adulterated. Therefore, all animals that had been identified as having consumed feed supplemented with pet food scraps contaminated with melamine and melamine-related compounds and that were not yet offered for slaughter were placed under State quarantine or voluntarily held by the producers. 

                    In a press release issued on May 7, 2007, FDA and FSIS announced the results of a human health risk assessment estimating the risk to human health from melamine and melamine-related compounds through the consumption of edible animal products derived from poultry, pork, and fish. This human health risk assessment has since been updated with new information and is hereafter referred to as the interim safety/risk assessment. The interim safety/risk assessment concludes that, based on currently available data and information, the consumption of pork, poultry, eggs, and domestic fish products from animals inadvertently fed animal feed contaminated with melamine and melamine-related compounds is very unlikely to pose a human health risk. In a Notice of Availability published in this issue of the                     **Federal Register**                    , FDA is announcing the availability of this “Interim Melamine and Analogues Safety/Risk Assessment.”                 

In the May 7, 2007, press release, FDA and FSIS also announced that several samples of feed from farms identified as having received contaminated pet food scraps had been tested by Federal laboratories or state laboratories using approved methods and the tests did not detect the presence of melamine and melamine-related compounds. The negative tests most likely reflected the fact that, because of dilution, the amount of melamine and melamine-related compounds present in the feed was so small that the compounds were no longer detectable by the approved testing method.

                    After considering the new information presented in the interim safety/risk assessment, together with the recent test results that found that melamine concentrations in some of the adulterated feed was below the level of detection, FSIS determined that it would be appropriate at that time for the Agency to permit, under certain conditions, hogs and chickens that had been identified as having consumed adulterated feed to be offered for slaughter. Therefore, at that time, FSIS decided to allow hogs and chickens identified as having consumed adulterated feed to be offered for slaughter for human food if the feed had                           ( print page 29947)                        been tested by a Federal laboratory or state laboratory using approved methods and the test did not detect the presence of melamine and melamine-related compounds. FSIS concluded that under these conditions, FSIS would be able to find that pork and poultry products from animals that had consumed adulterated feed were “not adulterated” and thus eligible to receive the mark of inspection.                 

At that time, hogs and chickens that had been identified as having consumed feed that had tested positive for melamine and melamine-related compounds, as well as animals that had been identified as having consumed feed supplemented with contaminated pet food scraps but none of the adulterated feed was available for testing, continued to be held under State quarantine or voluntarily by the producers. The disposition of these animals was to be determined on the basis of information from on-going investigations of hogs and chickens identified as having consumed adulterated feed. As part of these investigations, samples of animal feed, urine, and tissues were collected and analyzed for melamine concentration. 

In addition, based on the information that was available at the time, including information in the interim safety/risk assessment, FSIS concluded that it did not have sufficient evidence to demonstrate that the pork or poultry products that had already been distributed in commerce were injurious to health, unfit for human food, or otherwise adulterated under the FMIA or PPIA. Therefore, FSIS decided that it would not take action to remove from commerce any pork or poultry products that were produced from hogs and chickens that had consumed feed supplemented with pet food scraps contaminated with melamine and melamine-related compounds, but that had been slaughtered and processed prior to May 7, 2007. Thus, FSIS did not request that companies voluntarily recall the affected products from commerce. Information on the safety of pork and poultry from animals inadvertently fed adulterated feed that has become available since that time and is now reported in the interim safety/risk assessment further affirms this decision. 

## Actions Taken in Response to Tissue Test Results 

As discussed above, as part of the on-going investigations of hogs and chickens identified as having consumed feed supplemented with pet food scraps contaminated with melamine and melamine-related compounds, samples of animal feed, urine, and tissues were collected and analyzed for melamine concentration. Information from these ongoing investigations is being used to examine the relationship between melamine levels in feed and the levels in animal tissues, assess the changes in melamine level in the animals over time, and compare the level found in animals and feed with concentrations that could pose a risk to humans. 

On May 12, 2007, FSIS completed its validation of the methodology used to detect melamine concentration in pork tissues. The current analytical method for measuring melamine concentrations in pork can screen for melamine concentrations in pork tissue at 50 ppb and above. It should be noted that 50 ppb represents a conservative estimate for the method employed. All pork samples analyzed to date have had melamine concentrations below the validated 50 ppb screening level (ranges measured were estimated to be from 9 to 12 ppb), including samples from hogs identified as having consumed the highest percentage of pet food scraps, as to which the hog feed was composed primarily, if not exclusively, of the contaminated pet food scraps. 

On May 15, 2007, USDA issued a press release that announced that results of testing conducted on tissue samples from hogs confirm that meat from hogs fed animal feed supplemented with pet food scraps containing melamine and melamine-related compounds is safe for human consumption. The press release also announced that hogs being held on farms because they had consumed adulterated feed would be released and approved for slaughter and processing into human food. The press release explained that the interim safety/risk assessment had been updated to reflect the melamine concentration for pork of 50 ppb screening level. The conclusion of the interim safety/risk assessment did not change. 

Subsequent to the development of the validated testing method for hog tissue, FSIS validated the test methodology used to screen for melamine concentration levels in poultry tissue at the 50 ppb level. All poultry tissue samples analyzed to date have had melamine concentrations below 50 ppb. On May 18, 2007, a USDA press release announced that the validated test for poultry confirms the safety of eating meat from chickens fed poultry feed supplemented with pet food scraps containing melamine and melamine-related compounds. The press release also announced that, based on the results of the tests, approximately 80,000 birds that were being held on farms in Indiana were to be released and approved for slaughter and processing into human food. 

Thus, as announced on May 15, 2007, regarding hogs, and on May 18, 2007, regarding chickens, FSIS has decided to allow all animals identified as having consumed pet food scraps contaminated with melamine and melamine-related compounds to be offered for slaughter. Based on the results of the measured melamine concentration in pork and poultry tissue samples from animals exposed to adulterated feed, together with the findings of the interim safety/risk assessment, FSIS had determined that it is able to find that pork and poultry products from animals that have consumed feed that contains pet food scraps contaminated with melamine and melamine-related compounds are “not adulterated” and thus eligible to receive the mark of inspection as required under the FMIA and PPIA. 

                    At the time of publication of this                     **Federal Register**                     notice, all hogs and chickens that were previously under State quarantine or being held voluntarily by the producers because they had been identified as having consumed adulterated feed have been released.                 

### Request for Comments 

                    FSIS requests comments on the findings articulated by FSIS in this                     **Federal Register**                     notice, and specifically on whether the FSIS findings are appropriate to protect public health. Comments on the interim safety/risk assessment should be submitted to FDA as instructed elsewhere in this issue of the                     **Federal Register**                    .                 

### Additional Public Notification 

                    Public awareness of all segments of rulemaking and policy development is important. Consequently, in an effort to ensure that minorities, women, and persons with disabilities are aware of this document, FSIS will announce it on-line through the FSIS Web page located at                     *http://www.fsis.usda.gov/​regulations_​&​_​policies/​2007_​Notices_​Index/​index.asp*. FSIS will also make copies of this                     **Federal Register**                     publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations,                     **Federal Register**                     notices, FSIS public meetings, recalls, and other types of information that could affect or would be of interest to constituents and stakeholders. The update is communicated via Listserv, a free electronic mail subscription service for industry, trade and farm groups, consumer interest groups, allied health professionals, and other individuals                           ( print page 29948)                        who have asked to be included. The update is available on the FSIS Web page. Through the Listserv and Web page, FSIS is able to provide information to a much broader and more diverse audience. In addition, FSIS offers an e-mail subscription service which provides automatic and customized access to selected food safety news and information. This service is available at                     *http://www.fsis.usda.gov/​news_​and_​events/​email_​subscription/​*.                 

Options range from recalls to export information to regulations, directives and notices. Customers can add or delete subscriptions themselves and have the option to password-protect their account. 

Done at Washington, DC, on May 23, 2007. 

David Goldman, 

Acting Administrator. 

[FR Doc. 07-2649 Filed 5-25-07; 8:45 am] 

BILLING CODE 3410-DM-P