[Federal Register Volume 84, Number 154 (Friday, August 9, 2019)]
[Notices]
[Pages 39340-39341]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17053]



[[Page 39340]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3019]


Transit Times to Slaughter Facilities, Milking Frequency, and 
Interpretation of Zero-Day Withdrawal Periods and Zero-Day Milk Discard 
Times Assigned to New Animal Drugs; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
soliciting comments on transit times to slaughter, milking frequency, 
and how end users interpret zero-day withdrawal period or zero-day milk 
discard time statements found on new animal drug labeling.

DATES: Submit either electronic or written comments by October 8, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before October 8, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of October 8, 2019. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2019-N-3019 for ``Transit Times to Slaughter Facilities, Milking 
Frequency, and Interpretation of Zero-Day Withdrawal Periods and Zero-
Day Milk Discard Times Assigned to New Animal Drugs.'' Received 
comments, those filed in a timely manner (see ADDRESSES), will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Charli M. Long-Medrano, Center for 
Veterinary Medicine (HFV-150), Food and Drug Administration, 7500 
Standish Place, Rm. E340, Rockville, MD 20855, 240-402-0850, 
Charli.Long-Medrano@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    New animal drugs are assigned withdrawal periods and milk discard 
times when approved for use in food-producing animals. The withdrawal 
period or milk discard time is the interval between the time of the 
last administration of a new animal drug and the time when the animal 
can be slaughtered safely for human food or the milk can be consumed 
safely by humans, respectively.\1\ Zero-day withdrawal periods and 
zero-day milk discard times are assigned to new animal drugs when the 
labeling indications and directions (i.e., the approved conditions of 
use) allow entry of edible tissues, including milk, into the human food 
supply without regard to the elapsed time following the last drug 
administration.\2\ In most instances, we assign a zero-day withdrawal 
period or zero-day milk discard time to new animal drugs when data or 
information demonstrate that edible tissues or milk can be consumed 
safely at timepoints known as practical zero withdrawal or practical 
zero-milk discard time, respectively. Practical zero withdrawal \3\ and 
practical zero-milk discard time are

[[Page 39341]]

the shortest time intervals, including transit time to a slaughter 
facility, between administration of the last dose of the drug and 
slaughter or collection of milk for human consumption, respectively.
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    \1\ Guidance for Industry #3, ``General Principles for 
Evaluating the Human Food Safety of New Animal Drugs Used in Food-
Producing Animals'' (https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052180.pdf).
    \2\ Guidance for Industry #207 (VICH GL48), ``Studies to 
Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in 
Food-producing Animals: Marker Residue Depletion Studies to 
Establish Product Withdrawal Periods'' (https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM207941.pdf).
    \3\ Ibid.
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    Since the 1980s, the Agency has assumed that poultry spent at least 
6 hours in transit to a slaughter facility, cattle and pigs spent at 
least 12 hours in transit to a slaughter facility, and dairy cows were 
milked at 12-hour intervals. These assumptions led the Agency to define 
practical zero withdrawal as 6 hours for poultry and 12 hours for 
cattle and pigs and practical zero-milk discard time as 12 hours for 
lactating dairy cows. Accordingly, we currently assign a zero-day 
withdrawal period or zero-day milk discard time to new animal drugs if 
data from scientific studies or other available information confirm 
that residue concentrations in edible tissues or milk from treated 
animals are safe for human consumption after 6 hours withdrawn from 
drug for poultry or after 12 hours withdrawn from drug for cattle, 
pigs, sheep, goats, and lactating dairy animals (i.e., practical zero 
withdrawal and practical zero-milk discard time). A zero-day withdrawal 
period or zero-day milk discard time is often communicated to the end 
user by a labeling statement (e.g., ``zero-day withdrawal period,'' 
``zero-day milk discard time,'' or ``no withdrawal period or milk 
discard time is required'').
    The concept of practical zero withdrawal does not apply to drugs 
administered to laying hens (eggs only), food-producing aquatic 
animals, or honey bees. In these situations, we apply an ``absolute 
zero withdrawal approach,'' meaning that collection time or transit 
time is not considered and drug residues in eggs from treated hens, 
edible tissues from treated food-producing aquatic animals, and honey 
from treated honey bees must be below the assigned tolerance at all 
times during and after administration of a drug that has been assigned 
a zero-day withdrawal. Samples intended to support a zero-day 
withdrawal in these species are collected while animals are on the drug 
or immediately following the final drug administration.

II. Issues for Consideration

    We recognize that the animal agriculture industry has undergone 
significant changes since the 1980s, when the current assumptions about 
transit time to slaughter and milking frequency were formulated. An 
accurate understanding of current industry practices and the end user's 
interpretation of labeling statements is necessary to approve labeling 
that ensures the safe and effective use of new animal drugs, which is 
central to our mission to protect and promote public health. Therefore, 
we are requesting comments on current industry practices regarding 
transit times to slaughter for food-producing animals, milking 
frequency, and how end users interpret a zero-day withdrawal period or 
zero-day milk discard time. We welcome comments on these topics for all 
food-producing animals except laying hens, honey bees, and food-
producing aquatic animals because, as noted earlier, the concept of 
practical zero withdrawal does not apply to these classes of food-
producing animals.
    We invite comments on any or all the questions from individuals 
with direct knowledge of current industry practices. Please include the 
sector within the industry from where this information is derived 
(e.g., a veterinarian, cooperative, individual producer, hauler, trade 
organization, packers and processors, etc.), as well as the source of 
the information (e.g., survey, farm practices, published information, 
etc.) We specifically request comment on the following:
    1. What is the minimum amount of time that food-producing animals 
spend in transit to a slaughter facility in the United States (i.e., 
minimum transit time)? Please include the animal species and animal 
class(es) for each time provided.
    2. What is the minimum amount of time that food-producing animals 
spend at slaughter facilities in the United States prior to being 
slaughtered for human consumption (i.e., minimum holding time)? Please 
include the animal species and animal class(es) for each time provided.
    3. What milking frequencies do United States commercial dairy 
operations commonly use (e.g., two times per day, three times per day, 
greater than three times per day)? To what extent is each milking 
frequency used nationally, regionally, or within a particular sector 
(e.g., 25 percent of dairies nationally, 30 percent of dairies in the 
Midwest, 50 percent of dairies serviced by a veterinary practice, 
etc.)?
    4. How do end users of new animal drugs interpret labeling that has 
a ``zero-day withdrawal period'' or ``zero-day milk discard time,'' or 
that states ``no withdrawal period or milk discard time is required''?
    We will consider the submitted comments to evaluate if our current 
approach to assigning zero-day withdrawal periods and zero-day milk 
discard times to new animal drugs is appropriate.

    Dated: August 5, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17053 Filed 8-8-19; 8:45 am]
 BILLING CODE 4164-01-P


