CPG Sec 550.050 (Draft) Canned Ackee, Frozen Ackee, and Other Ackee Products – Hypoglycin A Toxin

Administrative draft guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

Contains Nonbinding Recommendations
Draft – Not for Implementation
Guidance for FDA Staff
Compliance Policy Guide
Sec. 550.050 Canned Ackee, Frozen
Ackee, and Other Ackee Products -
Hypoglycin A Toxin
Draft Guidance
This guidance is being distributed for comment purposes only.
Although you can submit comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to
ensure that the agency considers your comment on this draft document before it begins work on
the final version of the guidance, submit either electronic or written comments on the draft
guidance within 60 days of publication in the Federal Register of the notice announcing the
availability of the draft guidance. Submit electronic comments to http://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be
identified with the docket number listed in the notice of availability that publishes in the Federal
Register.
For questions regarding this draft document contact the Center for Food Safety and Applied
Nutrition (CFSAN) at 240-402-1700.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Regulatory Affairs
November, 2012

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2
Table of Contents
I. Introduction
II. Background
III. Policy
IV. Regulatory Action Guidance
V. Specimen Charges

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Draft – Not for Implementation
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Guidance for FDA Staff
Compliance Policy Guide
Sec. 550.050 Canned Ackee, Frozen Ackee, and
Other Ackee Products –
Hypoglycin A Toxin
This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's)
current thinking on this topic. It does not create or confer any rights for or on any person and
does not operate to bind FDA or the public. You can use an alternative approach if the approach
satisfies the requirements of the applicable statutes and regulations. If you want to discuss an
alternative approach, contact the FDA staff responsible for implementing this guidance. If you
cannot identify the appropriate FDA staff, call the telephone number listed on the title page of
this guidance.
I. 	Introduction:
The purpose of this Compliance Policy Guide is to provide guidance to FDA Staff relating to
canned ackee, frozen ackee, and other ackee products that contain the toxin hypoglycin A.
FDA's guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should
be viewed only as recommendations, unless specific regulatory or statutory requirements are
cited. The use of the word should in Agency guidances means that something is suggested or
recommended, but not required.
II. 	Background:
Ackee is a tropical fruit that grows to be 2 to 4 inches long when mature. The immature, unripe
fruit is green. When the healthy fruit is mature, the rind is yellow with more or less of an
overlay of bright red and has three bulging seams. As the fruit ripens, it splits open along the
seams into three sections revealing the edible part of the fruit, i.e., the fleshy, pale yellow arils.
At the top of the arils is a round, black, glossy, hard seed. Between the seed and each aril is a
pinkish membrane (raphe).

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Hypoglycin A, a heat stable toxin, is found at high levels in the unripe arils, seeds, raphe, and
rind of ackee (roughly at a level of 1000 parts per million (ppm)). Ingestion of hypoglycin A
may result in no symptoms or symptoms that range from mild (e.g., some vomiting) to severe
(e.g., vomiting with profound hypoglycemia, drowsiness, muscular exhaustion, prostration, and
possibly coma and death). When fully ripe, the hypoglycin A drops to negligible levels in the
arils and raphe, making them safe to consume (although the raphe is removed prior to
packaging). However, the rind and seeds still have high levels of hypoglycin A when the fruit is
fully ripe and should not be consumed. If the fruit is not properly processed, the finished
product may contain more than a negligible level of hypoglycin A and could pose a health risk.
Ackee can be picked from the tree when fully ripe (i.e., when the rind is fully open) and
processed the same day. However, the usual practice for most processors is to purchase fruit that
is mature (i.e., when the fruit is mostly yellow in color with more or less of an overlay of bright
red) and unopened or just beginning to split along the seams. The fruit is typically spread out on
ripening racks located outside the processing plant where it continues to ripen (splitting wide
open). Processing staff monitor the fruit while it ripens looking for fruit that has fully opened
and is ready for processing. Staff will also remove and discard ackee that are not fit for
processing (e.g., fruits that fail to open). If the fruit does not ripen by splitting fully open within
three to four days, the fruit is discarded. If the fruit does ripen, there is a dramatic, rapid loss of
hypoglycin A in the arils and raphe. The ripened fruit is selected for processing and the outer
rind and any attached debris are removed and discarded, usually outside of the processing plant.
Additionally, the fruit is inspected for bruising or damage to the arils or seeds and other
blemishes that indicate the fruit is not suitable for processing. Such bruised and damaged fruit
are also discarded. Prior to further processing and packaging, the black seeds and raphe are
removed, and the arils are visually inspected for damage, blemishes, or signs of spoilage. Prior
to canning or freezing, the arils are carefully washed in brine solutions. Additional visual
inspections are performed to identify any ackee that shows signs of damage or spoilage or signs
of any raphe that may still be present. Although complete removal of the raphe may not always
be possible, if the fruit was fully ripened, the amount of hypoglycin A in the raphe is negligible.
The presence of hypoglycin A in the finished ackee product at levels above 100 ppm can be
attributed to improper processing of the product and may pose a health risk. Problems during the
processing of ackee that can lead to potentially harmful levels of hypoglycin A above 100 ppm
in the finished product include (1) the inability of employees to identify and select fruit that is
ripe and fully opened; (2) purchasing fruit that appears ripened but may have been opened by the
supplier before the fruit was ripe; (3) heat shocking the fruit to make it split open faster than
nature intended (such that the levels of hypoglycin A would not drop to negligible levels in the
arils and raphe); and (4) improper cleaning and washing of the fruit.
FDA has determined that canned ackee, frozen ackee, or other ackee products containing
concentrations of hypoglycin A above 100 ppm have not been processed properly and that the
finished product may be injurious to health.

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III. 	Policy:
Under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act; 21 U.S.C.
342(a)(4)), a food shall be deemed adulterated if it has been prepared, packed, or held under
insanitary conditions whereby it may have been rendered injurious to health. Canned ackee,
frozen ackee, and other ackee products may be considered adulterated within the meaning of
section 402(a)(4) of the FD&C Act when hypoglycin A is present in the food at levels greater
than 100 ppm.
IV. 	Regulatory Action Guidance:
The following represents criteria for recommending seizure or import detention to
CFSAN/Office of Compliance/Division of Enforcement (HFS-606):
Canned ackee, frozen ackee, or other ackee product contains greater than 100 ppm of
hypoglycin A.
The method of analysis for hypoglycin A is described in the Journal of AOAC International
volume 85, no. 4, 2002 (G. Ware. “Method Validation Study of Hypoglycin A Determination in
Ackee Fruit”).
V. 	Specimen Charges:
Domestic Seizure
The article of food was adulterated when introduced into and while in interstate commerce and is
adulterated while held for sale after shipment in interstate commerce, within the meaning of the
Act, 21 U.S.C. 342(a)(4), in that it has been prepared and packed under insanitary conditions
whereby it may have been rendered injurious to health.
Import Detention
The article of food is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C
Act in that it appears to be adulterated within the meaning of section 402(a)(4) of the FD&C Act
in that it has been prepared and packed under insanitary conditions whereby it may have been
rendered injurious to health.
Issued: November, 2012