FAQs: FDA Egg Safety Rule

What is the Egg Safety Rule?
The Food and Drug Administration’s (FDA) Final Rule on egg safety requires shell egg producers to implement measures to prevent Salmonella Enteritidis (SE) from contaminating eggs. The rule required egg producers with 50,000 or more birds to be in compliance by July 9, 2010.

What is an Egg Safety Rule Program?
Components of the Egg Safety Rule Program include farm registration, prevention plan, biosecurity , house cleaning and disinfection, fly and rodent control, Salmonella testing (environmental and egg if environmental positive), refrigeration, and inspection by federal inspectors.

What is a Form 483?
A Form 483 is a notification of findings from the FDA following an inspection under the Egg Safety Rule. The 483 identifies questionable conditions or any significant deviation from stated protocols. A 483 is presented to the egg farmer’s senior management who must respond to the FDA, in writing within 15 business days, documenting corrective action specific to each condition cited. Then the egg farmer must wait for FDA to determine if the corrective action is sufficient for compliance. No timeframe is offered by FDA for their response.

What are the implications of a 483?
When a 483 is issued, it is not a determination of any violations of the Egg Safety Rule. The purpose of the 483 is to help egg farmers ensure they are in full compliance with the Egg Safety Rule and provide an opportunity to document and implement corrective action. The egg farmer must wait an unknown amount of time to learn from FDA if the corrective action is sufficient for compliance.

How Can You Access a 483?
The 483 is presented to the egg farmer’s management upon inspection. If FDA doesn’t feel corrective actions are sufficient, a subsequent warning letter may be issued and posted publically on FDA.gov.

For more information on the egg safety rule, visit: http://www.eggsafety.org/producers/food-safety-regulations

For more information on FDA inspections and Form 483, visit: http://www.fda.gov/ICECI/EnforcementActions/ucm256377.htm

Is Sparboe Farms Compliant with the Egg Safety Rule?
Sparboe Farms has a long commitment to egg safety and we remain keenly focused on continuous improvement. Notable dates:

1989	Sparboe Farms is one of the first egg farmers to begin voluntary Salmonella vaccination – today, 3 Salmonella vaccinations are administered at 3 critical states during the life of a hen to prevent Salmonella.
2000	Sparboe Farms begins voluntary Salmonella testing of chicks and chick papers (papers lining the trays chicks arrive in) arriving from the hatchery before they can be placed in our barns.
2005	Sparboe Farms implements a Salmonella Prevention Program as part of our standard biosecurity policy.
2010	Sparboe Farms meets guidelines set forth by the FDA Egg Safety Rule and confirms full compliance.
2011	All Sparboe's farms are inspected by FDA Egg Safety Rule inspectors who issue form 483s. Sparboe Farms responded promptly with corrective actions.

Has Sparboe Been Inspected Under the Egg Safety Rule?
Yes – the FDA has conducted inspections of many of the nation's egg producers, including Sparboe Farms.

Has Sparboe Been Issued any 483s?
Yes, Sparboe Farms received 483s at five of our farm inspections and promptly responded with corrective actions addressing all questionable conditions or significant deviations as noted by FDA. See the below timeline of inspections and written responses:

Inspection Number	Date updated SE Program to meet FDA Egg Rule	Date of Inspection	Date of Response Letter From Sparboe Farms to FDA with Corrective Action	Business Days between Inspection and Response
1	4/1/2011	4/25 - 4/29/11	5/18/2011	13
2	4/1/2011	4/25 - 5/5/11	5/25/2011	15
3	4/1/2011	5/9 - 5/12/11	5/31/2011	12
4	4/1/2011	6/20 - 6/21/11	7/12/2011	14
5	4/1/2011	7/20 - 7/22/11	8/6/2011	10

On November 16, 2011 Sparboe Farms received a warning letter issued by the Minneapolis office of the Food and Drug Administration. In the warning letter, FDA identifies areas of corrective action that were not sufficient for compliance with the egg safety rule. The warning letter contained 34 corrective actions. Many will not be resolved according to FDA until they audit that particular farm again. The remaining open objections include 5 paperwork items, 7 relating to how we count and record mice, and 7 relating to our testing protocol, which was changed immediately upon notification. These audits were the first conducted on our farms by the FDA since the implementation of the new egg safety rule. Consequently, we were not aware of the level of detailed response that the FDA requires and are working with them to be sure we provide all the detail they require.

To view the respective 483s by farm go the FDA site here:

http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/EggSafety/ucm279997.htm

Sparboe Farms FDA Egg Safety Rule Inspection Corrective Action Log

Has Sparboe Farms Found Environmental Positives for Salmonella?
Salmonella is found everywhere from chicken barns and hog farms to your own kitchen counter and even on vegetables we buy from the store so naturally we expect to test positive for Salmonella on occasion in the environment. As part of the Egg Safety Rule, and Sparboe’s Salmonella Prevention Program, swabs are taken in the barn environment and tested for Salmonella. Since July 2010, when the rule went into effect, Sparboe has taken more than 3000 swabs and have found some environmental positives.

The rule states that when we find an environmental positive, we are to do additional testing inside the eggs. During testing, eggs from positive barns are not sold unless pasteurized. To date, Sparboe has never found Salmonella inside a hen or an egg.

Has Sparboe Farms Found Salmonella in an Egg?
Through all of our testing we have never found Salmonella present in any of our eggs.

Are Sparboe Eggs Adulterated?

It is important to note for consumers that no eggs have ever tested positive. FDA can deem a food adulterated for a broad range of issues – many of which may have nothing to do with the actual food itself. This comes from the Federal Food Drug &Cosmetic Act and is the legal definition of adulterated versus what may be commonly thought of as being adulterated.

Has Sparboe Farms Been Part of a Recall?
Due to seasonality of egg sales and natural cycle of hen rotations, many egg producers purchase eggs from other egg producers to fill customer needs. Sparboe purchased a small amount of eggs from an egg producer that conducted a voluntary recall.

No Sparboe-produced eggs have ever been involved in any recall and Sparboe’s traceability process enabled us to identify all affected eggs and destroy or recall them. No Sparboe eggs have been found to contain Salmonella and Sparboe no longer purchases eggs outside of our own production or approved network of producers. Sparboe has been doing Salmonella testing long before the egg safety rule was enacted in July 2010 and remains in compliance with the rule.

Sparboe Farms wants consumers to remember to keep eggs refrigerated and cook them thoroughly when baking their favorite treat or cooking a healthy protein-packed breakfast.