[Federal Register Volume 59, Number 70 (Tuesday, April 12, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-8699]


[[Page Unknown]]

[Federal Register: April 12, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 93D-0259]

 

Action Levels for Aflatoxins in Animal Feeds; Revised Compliance 
Policy Guide; 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 revised Compliance Policy Guide (CPG) 7126.33 
entitled ``Action Levels for Aflatoxins in Animal Feeds.'' The CPG 
revises the action levels for aflatoxins in peanut products intended 
for animal feed use (i.e., peanuts, peanut meal, peanut hulls, peanut 
skins, and ground peanut hay) and provides guidance on levels of 
aflatoxin contamination of peanut products intended for use in animal 
feeds which, in the agency's view, may be necessary to support a charge 
of adulteration under certain provisions of the Federal Food, Drug, and 
Cosmetic Act (the act). FDA is inviting public comment concerning the 
revised action levels for peanut products that contain aflatoxins and 
that are shipped in interstate commerce for use in animal feeds.

DATES: Written comments by June 27, 1994.

ADDRESSES: Submit written requests for single copies of revised CPG 
7126.33 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 
revised CPG 7126.33 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 
revised CPG 7126.33 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: Daniel G. McChesney, Center for 
Veterinary Medicine (HFV-222), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1728.

SUPPLEMENTARY INFORMATION: FDA's use of action levels is defined in 
Sec. 509.4(c)(1) (21 CFR 509.4(c)(1)) of FDA's regulations governing 
unavoidable contaminants in animal food and food-packaging material. 
FDA is announcing that it has revised CPG 7126.33 ``Action Levels for 
Aflatoxins in Animal Feeds'' to reflect changes in the action levels 
for aflatoxins in peanut products intended for animal feed use, in 
accordance with Sec. 509.4(c)(2), and to provide guidance on levels of 
aflatoxin contamination of peanut products. FDA is inviting public 
comment on the revised action levels for aflatoxins in peanut products 
shipped in interstate commerce and intended for certain food-producing 
animals. The revised action levels are: (1) 100 parts per billion (ppb) 
aflatoxins for peanut products intended for breeding beef cattle, 
breeding swine, or mature poultry; (2) 200 ppb aflatoxins for peanut 
products intended for finishing swine (i.e., 100 pounds or greater); 
and (3) 300 ppb aflatoxins for peanut products intended for finishing 
(i.e., feedlot) beef cattle.
    The original 20 ppb action level remains unchanged for aflatoxins 
in peanut products for use by immature animals, dairy animals, and for 
aflatoxins in peanut products for which the intended use is not known 
(CPG 7126.33). Both the revised action levels and the one that remains 
unchanged were the subject of a memorandum that FDA's Associate 
Commissioner for Regulatory Affairs issued on December 7, 1990, to the 
FDA field offices (hereinafter referred to as the December 7, 1990, 
memorandum) (Ref. 1).
    Aflatoxins are added poisonous or added deleterious substances 
which, depending upon their level in food or feed, may cause the food 
or feed to be adulterated under section 402(a)(1) of the act (21 U.S.C. 
342(a)(1)). This section states that a food (or feed) is deemed to be 
adulterated if it bears or contains an added poisonous or deleterious 
substance ``which may render [the food (or feed)] injurious to 
health.'' If the government charges such a violation of the act, the 
government must show that there is a reasonable possibility of harm. 
Thus the action levels for aflatoxin are intended to represent levels 
of contamination above which, in the agency's view, the government 
could satisfy the ``may render it injurious'' test under section 
402(a)(1) of the act.
    Based on available scientific data, the agency believes that 
consumption of products containing aflatoxins in excess of 20 ppb may 
be injurious to the health of humans and immature animals, and that if 
such products are fed to dairy cattle, aflatoxin residues in fluid milk 
products that approach 0.5 ppb, the current action level for aflatoxin 
residues in such products (CPG 7106.10), may result. In 1989, FDA 
published revised action levels for aflatoxin in corn intended for use 
in animal feed (Ref. 2). FDA revised the action levels, which appear in 
CPG 7126.33, because it was able to further define subgroups for which 
levels of aflatoxin greater than 20 ppb may be necessary to support a 
``may be injurious to health'' charge of adulteration under section 
402(a)(1) of the act. Thus, for finishing swine, aflatoxin levels in 
excess of 200 ppb can support the charge, while levels above 300 ppb 
aflatoxin in corn and peanut products can support a charge under 
section 402(a)(1) of the act when the corn or peanut products are 
intended for finishing (i.e., feedlot) beef cattle. For breeding beef 
cattle, breeding swine, and mature poultry, corn and peanut products 
containing aflatoxin in excess of 100 ppb aflatoxin can support the 
adulteration charge. Furthermore, FDA concluded from its evaluation 
that meat and eggs from these animals would not contain increased 
residues of aflatoxin. For immature animals and dairy cows, aflatoxin 
levels in excess of 20 ppb can support the adulteration charge. For all 
other species and commodities the action level remains at 20 ppb until 
revisions to CPG 7126.33 are warranted.
    In deciding to revise the action levels for aflatoxin in peanut 
products, FDA relied on the data in the support paper entitled 
``Background Paper to Support Action Levels for Aflatoxin-Contaminated 
Corn'' (Ref. 2). Based on this information, FDA concluded that the 
inclusion of aflatoxin-contaminated peanut products in animal feed at 
the revised action levels would have a negligible effect on the tissue 
residue.
    Accordingly, the agency has adopted and will use the revised action 
levels as a basis for guiding its enforcement of section 402(a)(1) of 
the act, provided FDA is assured that peanut products in interstate 
commerce that contain more than 20 ppb aflatoxin are destined for the 
appropriate subgroups of animals. Without such assurance, the agency 
may conclude that the peanut products could be destined for humans, 
immature animals, or dairy cattle and, if it bears or contains more 
than 20 ppb aflatoxin, FDA believes that the Government would probably 
prevail in an enforcement action charging adulteration under section 
402(a)(1) of the act.
    In December 7, 1990, memorandum (Ref. 1) the agency recognized that 
all action levels, including those for aflatoxins, must be viewed and 
used as guidance rather than a definitive enforcement standard. The 
agency's action levels are not binding on the courts, the public 
(including food producers), or the agency. (See 55 FR 20782 (May 21, 
1990).) There may be situations where circumstances warrant enforcement 
action at levels below an action level or where enforcement action is 
not warranted even though an action level is exceeded. In considering 
enforcement action where aflatoxin levels are below the pertinent 
action level, FDA field offices must take into account the agency's 
ability to support the adulteration charge that will be included in the 
complaint. If a field office believes that enforcement action is 
warranted at levels below an action level, then the recommendation for 
enforcement action should include all compelling reasons for pursuing 
such action. Similar consideration is required if a field office 
believes that enforcement action where aflatoxin levels are above 
pertinent action levels is not warranted.
    The statements made in CPG 7126.33 are not intended to bind the 
courts, the public, or FDA or to create or confer any rights, 
privileges, immunities, or benefits on or for any private person, but 
are intended merely for internal FDA guidance.

References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Memorandum from the Associate Commissioner for Regulatory 
Affairs to the Regional Food and Drug Directors and District 
Directors, December 7, 1990.
    2. ``Background Paper to Support Action Levels for Aflatoxin-
Contaminated Corn,'' March 1989.
    Interested persons may, on or before June 27, 1994, submit to the 
Dockets Management Branch (address above) written comments regarding 
this notice. Two copies of any comments are to be submitted, except 
that individuals may submit one copy.
    This notice is issued under 21 CFR 10.85.

    Dated: March 28, 1994.
Gary Dykstra,
Acting Associate Commissioner for Regulatory Affairs.
[FR Doc. 94-8699 Filed 4-11-94; 8:45 am]
BILLING CODE 4160-01-F