![]() | December 6, 2001 |
On November 20, 2001, Judge Sifton granted FDA's motion for summary judgement to enjoin Blue Ribbon, a fish processor, from violating adulteration provisions of the Act. The court found that Blue Ribbon and three of its officers 1) had inadequate Hazard Analysis Critical Control Point ("HACCP") plans; 2) processed its fish products under insanitary conditions; and 3) introduced fish products contaminated with Listeria Monocytogenes (LM) into interstate commerce. The court also denied the individual defendants' motion to dismiss the complaint against them, relying upon earlier decisions from the Supreme Court which placed the responsibility for protecting the public health on individuals who had the opportunity to know about poor conditions at food processing companies, not consumers.
Rejecting Blue Ribbon's defense that new management had alleviated the insanitary conditions, the court focused instead on
defendants' lengthy history of violations. The court also held that defendants' HACCP plans were facially inadequate.
Blue Ribbon challenged the adulteration charge based on the presence of LM in its fish products by arguing that LM is not
an added substance and does not ordinarily present a risk to health because it affects only some segments of the
population. In the alternative, Blue Ribbon argued that if the court found LM to be an added substance, the FDA's
zero-tolerance policy violates provisions of the Food, Drug and Cosmetic Act. The court rejected these arguments, finding
that 1) LM is an added substance; 2) LM is "injurious to the health of significant populations of consumers;" and 3) the
FDA is not required to set a tolerance level for LM. The court granted relief as requested by the government, recognizing
that it was consonant with the legislative intent behind the Act: "[by| keeping contaminated fish processed under
conditions of filth off consumer's tables, this permanent injunction will serve that important purpose."
As part of the move of the Office of the Center Director, the Food Safety Staff will move the weekend of December 14, 2001. Effective December 17, 2001, all mail for employees of the Food Safety Staff should be sent to:
New telephone and fax information:
FAX: (301) 436-2605
Food Safety Staff Employees:
Dr. Robert E. Brackett | Mr. Louis J. Carson | ||
Dr. Eileen Parish | Mr. Heinz Wilms | ||
Ms. Cynthia A. Hall | Ms. Irma V. Robison | ||
Ms. Nikki Hargraves | Ms. Mary Ayling | ||
Ms. Marion V. Allen | Ms. Camille Brewer | ||
Ms. Bernice Friedlander | Dr. Marjorie Davidson | ||
Mr. Howard Seltzer | Ms. Laura Fox |
Food Safety Initiative Staff E-mail: chall@cfsan.fda.gov |
Office Number: (202) 260-8920 · FAX (202) 260-9653 CFSAN Web site: http://www.cfsan.fda.gov/ |
Hypertext updated by dav 2001-DEC-07