
[Federal Register Volume 80, Number 83 (Thursday, April 30, 2015)]
[Notices]
[Pages 24260-24261]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-10000]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-1305]


Multicriteria-Based Ranking Model for Risk Management of Animal 
Drug Residues in Milk and Milk Products; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or ``we'') is announcing 
the availability of a risk assessment entitled ``Multicriteria-Based 
Ranking Model for Risk Management of Animal Drug Residues in Milk and 
Milk Products.'' The risk assessment is a tool to assist with 
reevaluating which animal drug residues should be included in milk 
testing programs. We undertook this project in response to a request 
from the National Conference on Interstate Milk Shipments (NCIMS).

DATES: Submit either electronic or written comments on the risk 
assessment by July 29, 2015.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments on the risk assessment to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jane Van Doren, Center for Food Safety 
and Applied Nutrition (HFS-005), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-2927.

SUPPLEMENTARY INFORMATION: 

I. Background

    The NCIMS is a voluntary coalition that includes representatives 
from

[[Page 24261]]

Federal and State governments, the dairy industry, academia, and 
consumer groups. FDA collaborates with the NCIMS under a memorandum of 
understanding between the two entities. The NCIMS requested that we 
conduct an assessment of animal drug residues in the milk supply to 
inform potential changes to milk testing program requirements. In 
response, we developed a multicriteria-based ranking model of selected 
animal drugs used in dairy cows. The risk assessment provides a 
science-based, analytical approach to collate and incorporate relevant 
available data and information (Ref. 1). It provides a decision-support 
tool to assist with reevaluating which animal drug residues should be 
included in milk testing programs. The risk assessment also may be used 
to identify and prioritize research needs. The risk assessment model 
approach has undergone an independent external peer review. FDA's 
response to the peer review is available electronically on the FDA Web 
site (Ref. 2).
    The muticriteria-based ranking model is based on four overarching 
criteria that collectively contribute to a drug's score and rank within 
the group of drugs evaluated: (1) The likelihood that the drug will be 
administered to lactating dairy cows; (2) the likelihood that, 
following administration, drug residues would be present in milk (bulk 
tank or bulk milk pickup tanker); (3) the relative extent to which 
consumers could be exposed to the drug residue via consumption of milk 
and milk products; and (4) the potential for a human health hazard 
given exposure to the drug residue. The risk assessment describes the 
ranking model structure, the scientific data and assumptions used to 
inform scoring in the model, and the ranking results. The risk 
assessment also identifies data gaps and research needs.
    FDA invites comments that can help improve:
     The ranking model approach, including the specific 
criteria, scoring, and weighting scheme;
     the scientific data and assumptions used to inform scoring 
used in the model;
     the selection of animal drugs evaluated; and
     the clarity and the transparency of the risk assessment.

II. Comments

    Interested persons may submit either electronic comments to http://www.regulations.gov or written comments to the Division of Dockets 
Management (see ADDRESSES) regarding the risk assessment. It is only 
necessary to send one set of comments. Identify comments with the 
docket number found in brackets in the heading of this document. 
Received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to 
the docket at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the risk assessment 
at either http://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/ucm443549.htm or http://www.regulations.gov.

IV. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m. Monday through Friday, and 
are available electronically at http://www.regulations.gov. (We have 
verified the Web site addresses in this reference section, but we are 
not responsible for any subsequent changes to the Web sites after this 
document publishes in the Federal Register.)

    1. U.S. Food and Drug Administration (2015). ``Multicriteria-
Based Ranking Model for Risk Management of Animal Drug Residues in 
Milk and Milk Products.'' Accessible at http://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/ucm443549.htm.
    2. U.S. Food and Drug Administration (2015). ``Multicriteria-
Based Ranking Model for Risk Management of Animal Drug Residues in 
Milk and Milk Products: Peer Review Report.'' Accessible at http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/default.htm.

     Dated: April 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-10000 Filed 4-29-15; 8:45 am]
 BILLING CODE 4164-01-P


