Inspections, Compliance, Enforcement, and Criminal Investigations
Federacion Asociaciones Pecuarias 30-Oct-03
Department of Health and Human Services
Public Health Service
466 Fernandez Juncos Avenue
October 30, 2003
RETURN RECEIPT REQUESTED
Mr. Rafael Acevedo Torres, Controller
Federacion Asociaciones Pecuarias
P.O. Box 2635
Mayagiiez, Puerto Rico 00681
Product: Corn Starch XXX-0059093-6 (438-0320609-3)
Wheat Pellets XXX-0059091-0 (438-0320462-7)
Wheat Whole 438-0830111-3
Dear Mr. Acevedo:
The Food and Drug Administration (FDA) attempted to examine three shipments of grain products offered for importation into the United States by your firm on or about November 21, 2002, September 6, 2002, and February 14, 2003 under the above entry numbers, and found that the shipments were not held intact pending receipt of a "May Proceed" notice or "Release" notice from FDA.
On March 3, 2003, our investigator Pablo Feliciano visited your firm based on information supplied to us by your broker that the above-mentioned entries were ready for inspection. Upon arrival our inspector collected samples of corn starch and wheat pellets from these entries as identified by your firm.
Entries of corn starch under entry #XXX-0059093-6 (438-0320609-3) and wheat under entry #XXX0059091-
0 (438-0320462-7) were refused entry based on analyses conducted by FDA's Southeast Regional Laboratory, which showed that these entries contained illegal pesticide residues. The corn starch, entry #XXX-0059093-6 (438-0320609-3), tested positive for fenitrothion at 1.66 parts-per million (ppm) and the wheat, entry #XXX-0059091-0 (438-0320462-7), tested positive for pirimiphos-methyl at 0.187 ppm. Because there is no established tolerance set by the Environmental Protection Agency for either of these pesticides (Title 40, Code of Federal Regulations, section 180.409), they are unsafe within the meaning of section 408(a) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 346a(a)). These entries are adulterated within the meaning of section 402(a)(2)(B) of the Act (21 U.S.C. § 342(a)(2)(B)) because they contain unsafe pesticide residues.
On April 14, 2003, you met with FDA representatives at the Mayaguez Resident Post to inform them that the above two product entries had been used to manufacture animal feed, which was distributed to customers throughout Puerto Rico. Additionally, you informed us that another entry for which we were requesting location for examination, entry # 438-0830111-3, had also been used and distributed in this manner.
As the importer on record, it is your responsibility to hold the product intact until it is released by FDA. Distribution of these products is a violation of Title 21, Code of Federal Regulations, section 1.90, which requires importers to hold an entry intact pending receipt of a "May Proceed Notice" or "Release Notice" from FDA.
Failure to promptly correct this violation and prevent future violations may result in regulatory action without further notice such as seizure, injunction, or detention without physical exam of future shipments. It is your responsibility, as the importer, to ensure that imported products meet all requirements of the Act and the regulations promulgated thereunder.
We request a response in writing within fifteen (15) working days of receipt of this letter explaining the specific steps you have taken to correct the violation, including an explanation of each step being taken to prevent the recurrence of the violation.
Your written reply should be addressed to the Food and Drug Administration, Attention: Carlos I .Medina, Compliance Officer, 466 Fernandez Juncos Avenue, San Juan, Puerto Rico 00901.
Donald J. Voeller