[Federal Register Volume 62, Number 139 (Monday, July 21, 1997)]
[Notices]
[Page 39003]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-19123]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 92G-0432]
Yandilla Mustard Oil Enterprise Pty. Ltd.; Withdrawal of GRAS
Affirmation Petition
AGENCY: Food and Drug Administration., HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
withdrawal, without prejudice to a future filing, of a petition (GRASP
0G0359) proposing that low erucic acid mustard seed oil be affirmed as
generally recognized as safe (GRAS) as a direct human food ingredient.
FOR FURTHER INFORMATION CONTACT: Nega Beru, Center for Food Safety and
Applied Nutrition (HFS-206), Food and Drug Administration, 200 C St.
SW., Washington, DC 20204, 202-418-3097.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of January 22, 1993 (58 FR 5736), FDA announced that a
petition had been filed by Yandilla Mustard Oil Enterprise Pty. Ltd.,
Wallendbeen, NSW 2588, Australia. This petition proposed that low
erucic acid mustard seed oil be affirmed as GRAS for use as a direct
human food ingredient.
In response to repeated requests from the petitioner urging action,
on October 4, 1994, the agency informed the petitioner that a decision
on whether the agency concurs with the petitioner's determination that
Yandilla mustard seed oil is GRAS is not likely to be forthcoming for
some time. The agency cited resource constraints and the work that
still needed to be done in order to resolve certain safety issues
raised by the petition. No response was received from the petitioner.
By letter dated April 4, 1996, FDA reiterated to the petitioner why
the agency is unlikely to reach a decision on the petition in the near
future and further informed the petitioner of an agency initiative to
remove from its pending petition inventory those petitions on which the
agency is unable to reach closure in the near future. In that letter,
the agency requested that the petitioner withdraw the petition, without
prejudice to a future filing, and asked the petitioner to inform the
agency of its decision within 30 days of the date of the letter; the
agency added that failure to respond within that time would be
considered tacit approval to withdraw the petition. More than 1 year
has passed since the letter was sent and the firm has not responded.
Indeed, the last communication from the petitioner was in June 1994.
Therefore, the agency is announcing that it considers this petition to
be withdrawn by the firm, without prejudice to a future filing.
Dated: July 2, 1997.
Janice F. Oliver,
Deputy Director for Systems and Support, Center for Food Safety and
Applied Nutrition.
[FR Doc. 97-19123 Filed 7-18-97; 8:45 am]
BILLING CODE 4160-01-F
