[Federal Register Volume 59, Number 140 (Friday, July 22, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-17813]


[[Page Unknown]]

[Federal Register: July 22, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94D-0051]

 

Guideline for Establishing a Safe Concentration; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guideline entitled ``Guideline for Establishing a 
Safe Concentration.'' This guideline includes information and guidance 
to regulated industry and the public on food factors. This guideline is 
being made available as a revision to a document entitled ``General 
Principles for Evaluating the Safety of Compounds Used in Food-
Producing Animals'' which is a compilation of eight guidelines 
(hereinafter referred to as ``the compilation''). The new guideline 
replaces guideline IV entitled ``Guideline for Establishing a 
Tolerance,'' which is no longer in effect.

DATES: Written comments may be submitted at any time.

ADDRESSES: Submit written requests for single copies of the guideline 
to the Communications and Education Branch (HFV-12), Center for 
Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855. Send two self-addressed adhesive labels to assist 
that office in processing your requests. Submit written comments on the 
guideline to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857. 
Requests and comments should be identified with the docket number found 
in brackets in the heading of this document. A copy of the compilation 
which includes the new guideline entitled ``Guideline for Establishing 
a Safe Concentration'' and received comments are available for public 
examination in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Margaret A. Miller, Center for 
Veterinary Medicine (HFV-156), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1692.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 31, 1987 
(52 FR 49589) FDA announced the availability of a compilation of seven 
guidelines entitled ``General Principles for Evaluating the Safety of 
Compounds Used in Food-Producing Animals.'' The compilation was issued 
in accordance with FDA's requirement under the general safety 
provisions of sections 409, 512, and 706 of the Federal Food, Drug, and 
Cosmetic Act (the act) to determine whether each food additive, new 
animal drug, or color additive proposed for use in food-producing 
animals is safe for those animals and whether the edible products 
derived from treated animals are safe. The pertinent regulations 
implementing the statutory provisions are in 21 CFR part 70, 21 CFR 
514.1, and 21 CFR part 570.
    Under the act, the sponsor of a compound is required to furnish FDA 
with the scientific data necessary for demonstrating that residues of 
the sponsored compound in the edible products of treated animals are 
safe. The compilation was developed to inform sponsors of the 
scientific data that FDA believes will provide an acceptable basis for 
determining the safety of the compound.
    Guidelines state procedures or practices that may be useful to the 
persons to whom they are directed, but are not legal requirements. 
Guidelines represent the agency's position on a procedure or a practice 
at the time of their issuance. A person may follow a guideline or 
choose to follow alternate procedures or practices. If a person chooses 
to use alternate procedures or practices, then that person may wish to 
discuss the matter further with the agency to prevent an expenditure of 
money and effort on activities that may later be determined to be 
unacceptable to FDA. A guideline does not bind the agency, and it does 
not create or confer any rights, privileges, or benefits for or on any 
person. When a guideline states a requirement imposed by statute or 
regulation, however, the requirement is law and its force and effect 
are not changed in any way by virtue of its inclusion in the guideline.
    FDA is announcing the availability of a new guideline entitled 
``Guideline for Establishing a Safe Concentration'' that includes 
information and guidance to regulated industry and the public on food 
factors. This guideline is being made available as a revision to the 
compilation and replaces guideline IV entitled ``Guideline for 
Establishing a Tolerance,'' which is no longer in effect.
    The new guideline sets out new consumption values that FDA's Center 
for Veterinary Medicine (CVM) will use in partitioning the Acceptable 
Daily Intake (ADI) for drug residues among the edible products of food 
producing animals. The new daily consumption values for total red meats 
and poultry, across all species, are 300 grams (g) of meat (as muscle 
tissue), 100 g of liver, 50 g of kidney, 50 g of fat, 100 g of eggs, 
and 1.5 liters (l) of milk. These values are a more realistic estimate 
of actual food consumption than the values currently used by CVM.
    CVM will continue to regulate eggs and milk as independent 
commodities, which means that these products are not considered 
components of the 500 g of edible muscle and organ tissues. The intake 
estimate of milk will remain 1.5 l. CVM will now assume, however, that 
an individual consumes an entire portion of meat and edible tissues and 
an entire portion of milk on a daily basis. Therefore, a part of the 
ADI will be reserved for milk when evaluating products approved in 
lactating dairy cows and products seeking approval in both lactating 
dairy cows and another animals species. The other part of the ADI will 
be partitioned among the animal tissues as described above. For 
products approved in both laying hens and other animals, a part of the 
ADI will be reserved for eggs.
    In addition to incorporating the new food factors, the concept of 
negligible tolerance has been omitted from the new guideline because 
CVM usually can establish a finite or zero tolerance when assessing the 
safety of a drug.
    Interested persons may, at any time, submit to the Dockets 
Management Branch (address above) written comments on the guideline. 
Two copies of any comments are to be submitted, except that individuals 
may submit one copy. Comments may be seen in the office above between 9 
a.m. and 4 p.m., Monday through Friday.
    Received comments will be considered in determining whether further 
revision of the guideline is necessary.
    A copy of the compilation which includes the new guideline entitled 
``Guideline for Establishing a Safe Concentration,'' is available for 
public examination in the office above, between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: July 15, 1994.
 Michael R. Taylor,
 Deputy Commissioner for Policy.
[FR Doc. 94-17813 Filed 7-21-94; 8:45 am]
BILLING CODE 4160-01-F