Bala Swaminathan, Ph.D.IHRC, Inc.

Atlanta, GA

Source: www.cdc.gov/salmonella/typhimurium/

Public health officials go public….all hell breaks loose

Dealing with the press Dealing with CDC Dealing with attorneys Dealing with politicians and their staff Dealing with the general public

PulseNet and Multistate Outbreaks

Public health agencies are advisory in nature and do not usually use enforcement tools

Regulatory agencies regulate specific industries and have the force of the law behind them. They are expected to enforce the law using enforcement tools available to them

Federal Food, Drug and Cosmetic Act Code of Federal Regulations, Title 21

Federal Meat Inspection Act; Wholesome Meat Act

Federal Poultry Products Inspection Act; Wholesome Poultry Products Inspection Act

Egg Products Inspection Act

SEC. 301. [21 USC §331] Prohibited acts Note: revisions were posted to this section in February 2008. The following acts and the causing thereof are hereby prohibited: 1 (a) The introduction or delivery for introduction into interstate commerce of any food, drug, device, or

cosmetic that is adulterated or misbranded.

(b) The adulteration or misbranding of any food, drug, device, or cosmetic in interstate commerce.

(c) The receipt in interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.

(d) The introduction or delivery for introduction into interstate commerce of any article in violation of section 404, 505 or 564.

(e) The refusal to permit access to or copying of any record as required by section 412, 414, 416, 417(g), 504, 564, 703, 704(a), 760, or 761; or the failure to establish or maintain any record, or make any report, required under section 412, 414(b), 416, 417, 504, 505(i) or (k), 512(a)(4)(C), 512 (j), (l) or (m), 572(i), 2 515(f), 519, 564, 760, or 761 or the refusal to permit access to or verification or copying of any such required record.

(f) The refusal to permit entry or inspection as authorized by section 704.

(g) The manufacture, within any Territory of any food, drug, device, or cosmetic that is adulterated or misbranded.

No adulterated or misbranded food in interstate commerce

Sec. 402. [21 USC §342] Adulterated Food Note: revisions were posted to this section in December 2007. A food shall be deemed to be adulterated— 1 (a) Poisonous, insanitary, or deleterious ingredients. (1) If it bears or contains any poisonous or deleterious substance which may render it

injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health; [or] 2 (2)(A) 3 if it bears or contains any added poisonous or added deleterious substance (other than a substance that is a pesticide chemical residue in or on a raw agricultural commodity or processed food, a food additive, a color additive, or a new animal drug) that is unsafe within the meaning of section 406; or (B) if it bears or contains a pesticide chemical residue that is unsafe within the meaning of section 408(a); or (C) if it is or if it bears or contains (i) any food additive that is unsafe within the meaning of section 409; or (ii) a new animal drug (or conversion product thereof) that is unsafe within the meaning of section 512; or (3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or (4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; or (5) if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter; or (6) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (7) if it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 409.

SEC. 303. [21 USC §333] Penalties Note: revisions were posted to this section in February 2008. [Note: See prospective amendment note below.] (a) Violation of 21 USC § 331; second violation; intent to defraud

or mislead. (1) Any person who violates a provision of section 301 shall

be imprisoned for not more than one year or fined not more than $1,000, or both.

(2) Notwithstanding the provisions of paragraph (1) of this section, if any person commits such a violation after a conviction of him under this section has become final, or commits such a violation with the intent to defraud or mislead, such person shall be imprisoned for not more than three years or fined not more than $10,000 or both.

Sampling Integrity of Sample - Chain of Custody Quality of Data

Use of official/standard methods Integrity of data Statistical analysis/probabilities Analysis & interpretation of data – Scientific

validity

Regulatory agency refers to Department of Justice DOJ does not routinely pursue criminal prosecution

for food safety violations My CDC experience

Raw milk in Oregon - settled out of court Hudson beef – U.S. Attorney in Nebraska asked for

information on the outbreak but the case was never pursued

Salmonella contamination of peanut products, 2008-2009, criminal prosecution???Not yet

So where is the deterrent?

Peanut Corp. of America to Pay Settlements The Peanut Corp. of America (PCA) will give settlement payments to

the families of nine victims who died and 44 children who got sick from salmonella-contaminated PCA peanut butter last January, 2009. Kellogg has agreed to pay part of the settlement payments: contaminated peanut ingredients used in its crackers came from PCA.

After PCA filed for bankruptcy, its insurer, The Hartford, created a $12 million fund for wrongful death and personal injury claims. The lawyers of the victims, Attorneys Ron Simon and Bruce Clark, urged the court for expediency. "All of my clients have said, ‘We desperately want these settlements. It has been a year and a half,’" said Simon.

Settlement payments to be made include are a $1 million payment to the estate of a woman from Alabama and less than $50,000 for the children and payment for one man may reach about $2 million.

ConAgra Settles Hundreds of Peanut Butter Salmonella Cases A Texas law firm announced today that they have negotiated confidential settlements for 752 individuals

across the US who became ill after consuming Peter Pan and Great Value peanut butter manufactured by ConAgra Foods, Inc.

In November 2006, public health officials at CDC and state health departments detected a substantial increase in the reported incidence of Salmonella Tennessee illnesses. Salmonella.

Illness was linked to the consumption of 2 brands of peanut butter (Peter Pan and Great Value) produced at ConAgra's plant in Sylvester, Georgia. Based on these findings, ConAgra ceased peanut butter production at the plant and recalled both products on February 14, 2007.

As of the CDC's last reported summary in September 2007, over 714 cases of Salmonella Tennessee illness had been linked to the consumption of the contaminated peanut butter. The plant was shut down and eventually rebuilt to incorporate more food safety measures in the peanut butter production process.

Shortly after the recall, lawyers from Simon & Luke led a team into ConAgra's peanut butter plant to inspect and document the conditions that caused the contamination of the peanut butter. Extensive laboratory testing by the CDC, FDA, and the law firm found the outbreak strain of Salmonella Tennessee in several opened and unopened jars of Peter Pan and Great Value peanut butter. In addition, Salmonella Tennessee was found in environmental samples obtained from the plant during inspections.

Additional Salmonella Tennessee peanut butter claims against ConAgra continue to be prosecuted.

Listeriosis Class Action Settled for $27 Million A $27 million settlement has been reached between Maple Leaf

Foods of Canada, and the plaintiffs in a class action suit.

The suit, brought against the food producer in 2008, stemmed from a nationwide listeria outbreak which killed at least 20 people. In each of the cases where someone died, their estate will receive $120,000 and the immediate family members will receive 'substantial amounts.'

Other claimants may be eligible for up to $125,000 each, depending on how severely their health was affected.

Anyone who consumed Maple Leaf meat products between January 1 and August 31, 2008 is eligible to make a claim.

Tomato Salmonella Hollidaysburg, PA: (Nov-27-07) Max Christian Anslinger, an

Altoona resident, brought charges against Sheetz Convenience Stores, alleging that it sold salmonella tainted tomatoes. Anslinger was one of more than 400 people sickened by tomatoes sold on sandwiches and other foods at Sheetz stores in Pennsylvania and eight other states in 2004. Sources close to the case stated that the case was pivotal because it was the vehicle for the complicated legal process used to determine where the tomatoes originated. As part of a settlement reached, sources stated that the company reached an out-of-court agreement with Anslinger. Terms of the deal were kept confidential. The plaintiff's legal counsel praised Sheetz for stepping forward quickly to take care of sick customers. Records state that only 10 customer claims remain; eight in Pennsylvania and two in Maryland.

State statute that provides public access to government documents and records

Public body must respond to FOIA requests within five business days after receipt of request

If additional time is needed, public body must notify requester within five business days of receiving request

Follow established protocol of your organization

Keep your supervisor informed Tread carefully to balance the requester’s right

to information with aiding a profit motive Be aware of the Freedom of Information Act

stipulations Try to promptly respond to “reasonable” FOIA

requests