United States v. Chung's Products LP (941 F. Supp. 2d 770, 2013)

OPINION AND ORDER

MELINDA HARMON, District Judge.

Pending before the Court is the Government’s Motion for Summary Judgment (Doc. 16), as well as Defendants Chung’s Products, LP, Charlie A. Kujawa, and Gregory S. Birdsell’s response (Doc. 30), the Government’s reply (Doc. 34), Defendants’ surreply (Doc. 38), the Government’s response thereto (Doc. 41), Defendants’ supplemental declaration (Doc. 47), and the Government’s response thereto (Doc. 50). Upon review and consideration of this motion, the response, replies, and surreplies thereto, the relevant legal authority, and for the reasons explained below, the Court finds that the motion should be granted.

I. Background and Relevant Facts

This is a statutory injunction proceeding brought under the Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 331 et seq.

Defendant Chung’s Products, LP (“Chung’s”) operates a food processing facility at 3907 Dennis Street in Houston, Texas. (Doc. 1 at 2.)

Defendant Charlie A. Kujawa (“Kujawa”) is president of operations at Chung’s. (Doc. 16, Exh. 2.) Kujawa represented Chung’s at a regulatory meeting with Federal Drug Administration (“FDA”) officials on March 6, 2008. (Doc. 16, Exh. 2C.) During the most recent inspection by the FDA in June 2009, Kujawa identified himself as the “most responsible person” at Chung’s facility. (Doc. 16, Exh. 1.)

Defendant Gregory S. Birdsell (“Bird-sell”) was the director of quality assurance at Chung’s. (Doc. 30, Exh. 2.) Birdsell also represented Chung’s at a regulatory meeting with the FDA on March 6, 2008. (Doc. 16, Exh. 2C.) Along with Kujawa, Birdsell was the point-of-contact for FDA investigators during the two most recent inspections. (Doc. 16, Exh. 1.) Birdsell has since left Chung’s, and Eddy T. Lee is now the director of quality assurance. (Doc. 50 at 1.)

Chung’s facility falls under the dual jurisdiction of the U.S. Department of Agriculture (“USDA”) and the FDA. (Doc. 30 at ¶ DJI.) Chung’s manufactures vegetable and shrimp egg rolls, which are regulated by the FDA, as well as chicken and pork egg rolls, which are regulated by the USDA. (Doc. 16, Exh. 1.) Chung’s also imports prepared shrimp spring rolls from China, which it sells under the Chung’s brand name. (Id.)

The FDA inspected Chung’s facility in 2005, 2006, 2007, and 2009, documenting sanitation conditions and verifying food safety records. (Doc. 16, Exhs. 1H, 1G, ID, IB.) After each inspection, the FDA investigator issued observations on an FDA Inspectional Observation Form 483 (“Form 483”). (Id.) Each Form 483 documented numerous observations of noncompliance regarding sanitation practices and monitoring of food safety hazards. (Id.) The investigator discussed each of these observations with Birdsell and Kujawa during meetings prior to the issuance of the forms. (Id.) In addition, the FDA held meetings with Chung’s following the 2006 and 2007 inspections. (Doc. 16, Exh. 2E, 2C.)

On October 30, 2007, the FDA issued a warning letter to Chung’s citing “significant violations” of the FDCA and food safety regulations under. (Doc. 16, Exh. 2A.) Chung’s sent written responses to each violation and observation made at the four inspections and requested two meetings with FDA officials. (Doc. 30, Exh. A4 at 2.) Chung’s says all issues were promptly resolved. (Doc. 4 at 2.) The Government alleges that despite “multiple warnings by the FDA, Defendants have demonstrated either inability or unwillingness to develop and implement adequate sanitation measures and an appropriate [Hazard Analysis Critical Control Point] plan to control the risk of microorganisms in their food.” (Doc. 1 at 9.) The Government concludes that “[b]ased on their repeated course of conduct, Defendants will continue to violate 21 U.S.C. §§ 331(a) and (k) unless restrained by order of this Court.” (Doc. 1 at 9.)

A. Sanitation

During each inspection of Chung’s facility, the FDA documented recurrent sanitation concerns, including the use of unsanitary hoses, condensation problems, and poor employee hygiene. (Doc. 16, Exhs. 1 H, 1 G, ID, 1 B.)

At the 2005 inspection, the FDA investigator observed employees using filthy hoses “sitting in 6 inches of water” on the floor to clean a vegetable grinder and fill a tank of shrimp by submerging the hose in the tank. (Doc. 16, Exh. 1H.) At the 2007 inspection, the investigator again observed an employee on multiple occasions picking a hose off the floor to “either wash down equipment or fill the hand dip buckets or white 55 gallon barrel with water” used for moistening egg roll wrappers. (Doc. 16, Exh. ID.) In April 2010, the Defendants’ expert witness, Dr. Leslie Bluhm (“Bluhm”) observed similar acts during his inspection. (Doc. 30, Exh. C at 4.)

At the 2005 inspection, the investigator also observed condensation dripping from an air conditioning unit to the floor near egg roll filling ingredients. (Doc. 16, Exh. 1H.) Condensation was again observed dripping from multiple air conditioning units in 2007. (Doc. 16, Exh. ID.) One unit leaked “directly over the final product conveyor belt.” (Id.) Two other air conditioners leaked above ingredients in the filling room and “[c]ondensate was observed dripping into the shrimp egg roll filling.” (Id.) In 2009, the investigator observed an accumulation of ice and debris, including discarded egg rolls on the floor of a freezer where finished egg rolls were stored. “According to Mr. Birdsell[,] the air-conditioning system had a leak and the ice formed due to the leak.” (Doc. 16, Exh. IF at 35.) The investigator also observed an “oily brown substance” running down the length of the wall of the refrigerator near raw egg roll wrappers and a “black, mold-like substance” on a shelf where raw chicken and onions were stored. (Id.)

At the 2005 inspection, the investigator observed employees handling garbage and then processing vegetables without washing their hands. (Doc. 16, Exh. 1H.) Again, at the 2007 inspection, the investigator reported that employees were handling bins of egg roll filling after using a floor squeegee without washing their hands. (Doc. 16, Exh. ID.) One employee rinsed his hands in the water used for dipping the egg roll wrappers. (Id.) After the 2007 inspection, Chung’s responded to these problems by conducting “on-site training of line workers in proper sanitation and personal hygiene practices.” (Doc. 30, Exh. A8 at 2.) At the 2009 inspection, the investigator observed Defendant Birdsell not covering his beard with a beard net in the mixing room, as required by 21 C.F.R. § 123.11(b)(6) as well as by Chung’s sanitation policy. (Doc. 16, Exh. IF at 34.) Birdsell was “responsible for providing [sanitation practices] training” at Chung’s. (Doc. 30, Exh. A17 at 8.)

B. Recordkeeping

The Government alleges Birdsell and Kujawa failed to cooperate with FDA investigators in providing sanitation records. The parties disagree whether Chung’s properly disclosed its sanitation records during the 2009 inspection. The investigator reported:

Mr. Kujawa and Mr. Birdsell would not provide all of the firm’s sanitation records during the inspection. After several requests and a great deal of discussion ... Mr. Birdsell explained that if I could name the document or identify the specific documents that I wished to see he would gladly provide them.... Mr. Birdsell was not willing to provide all the necessary sanitation records since I did not identify them by their individual title or document name. I specifically asked for the firm’s records that covered the eight items of sanitation that are required to be maintained by a firm that manufactures seafood products.

(Doc. 16, Exh. IF at 38.) Kujawa testified:

In my presence, Mr. Birdsell ... asked [the investigator] exactly what information he needed so that we could point it out to him and show him precisely where each required sanitation element was contained in our documentation and programs but [the investigator] was not able to define what he wanted to see.

(Doc. 30, Exh. A at 23.) Chung’s gave the investigator documents containing its Sanitation Standard Operating Procedures (“SSOPs”) and sanitation checklists for certain dates. (Doc. 30, Exh. A17 at 10.) SSOPs are recommended practices, not records of observations. 21 C.F.R. § 123.11. The checklists contained lists of sanitation items. (Id.) Next to each item was an “A” for “Accept” and an “R” for “Reject.” Twice a day, an employee was to examine each item and circle the appropriate letter. (Id.) The items on Chung’s sanitation checklists do not correspond to the eight requirements for Sanitation Control Records:

Required Sanitation Control Records (21 C.F.R. § 123,11)_

(1) Water safety

(2) Cleanliness

(3) Prevention of cross-contamination

(4) Handwashing, toilet facilities

(5) Control of food contaminants

(6) Control of toxic chemicals

(7) Control of sick employees

(8) Pest control

Chung’s Sanitation Checklists (Doe. 30, Exh. A17)_

A. Preoperational Checklist

(1) Equip.

(2) Walls

(3) Floors

(4) Ceiling

B. Operational Checklist

(1) GMP [Good Manufacturing Practice]

(2) Equip.

(3) Overhead_’

At the meeting after the 2009 inspection, Birdsell asserted that the eight sanitation items required by 21 C.F.R. § 123.11 for seafood processors were included within the Good Manufacturing Practice (“GMP”) item. (Doc. 16, Exh. IF at 55.) GMPs are sanitation requirements for food processors. 21 C.F.R. § 110. They overlap to some extent with the eight items required for seafood Sanitation Control Records. 21 C.F.R. § 123.11. However, GMPs do not require recordkeeping. Birdsell clarified that the GMP item in Chung’s checklist referred to Chung’s GMP policy, a three-page document containing forty-one GMPs. (Doc. 30, Exh. A17, Sub-Exh. 9.) The FDA investigator reported:

I explained to Mr. Birdsell that I thought it would be very difficult for anyone to remember all the items on the three page GMP document and properly recognize the deficiencies and note them on the record without some type of further prompt. Mr. Birdsell assured me that his employees were capable of remembering the information and correctly filling out the GMP section of the records that were provided during the inspection.

(Doc. 16, Exh. IF at 55.)

In its written response to the 2009 investigation, Chung’s explained that the checklists actually referred to Chung’s SSOP policy, not the GMP document identified by Birdsell. (Doc. 30, Exh. A17, Sub-Exh. 10-1.) Chung’s refers to its SSOP policy document variously as “SSOP,” “GMP SSOP,” or “SSOP/GMPs,” among other names. (Id., Exh. A17 at 10.) Elsewhere in its written response, Chung’s refers to its GMP policy document as “Chung’s GMPs,” its actual title. (Id., Sub-Exh. 9; Id. at 8.) Kujawa refers to the same written response as the final authority on the matter:

Chung’s provided full documentation of its sanitation control records to [the] FDA in its [Form] 483 response and the completeness of our program in this area is further bolstered by the 2010 USDA [inspection] report and is confirmed by Dr. Leslie Bluhm in his Declaration.

(Doc. 30, Exh. A at 23.)

The USDA’s report states that Chung’s SSOP records comply with 9 C.F.R. § 416.13(c), which governs meat and poultry processors. (Doc. 30, Exh. A12 at ¶ GS8.) However, the USDA report does not refer to 21 C.F.R. § 123.11, which contains the eight minimum Sanitation Control Records requirements for seafood processors. (Id.)

During the 2009 inspection, the FDA investigator asked Birdsell and Kujawa for documentation of egg rolls imported from China, as required by 21 C.F.R. § 123.12(a). The investigator reported, “During the inspection, I asked for a copy of the import documents for the last shipment of shrimp rolls from China. Both Mr. Birdsell and Mr. Kujawa denied my request for the information.” (Doc. 16, Exh. IF at 31.) Importers of seafood must make available to FDA investigators “written verification procedures” that ensure compliance with Hazard Analysis Critical Control Points (HACCP) regulations in the foreign facility, including (1) product specifications and (2) “affirmative steps” that “provide an equivalent level of assurance of compliance” as required for domestic facilities. 21 C.F.R. § 123.12(a).

There is disagreement between the 2009 Form 483 and Chung’s response as to which documents were in fact provided to the investigator in regard to the imported egg rolls. The Form 483 states that Chung’s “provided the case labeling and the final product labeling” for its imported egg rolls. (Doc. 16, Exh. 1F at 31.)

Both Mr. Birdsell and Mr. Kujawa refused to provide this information during the inspection. Mr. Kujawa stated that it was not within the scope of my inspection even after I pointed out the specific import regulation during our discussion. I explained to Mr. Kujawa that the [Form 483] observation would remain on the [Form 483] since that is what occurred during the inspection and ... information [provided] during the closing discussion was not sufficient to correct the deviation that was observed.

(Id. at 54.) Chung’s response states that “Product Specifications for the Spring Rolls mentioned in the FDA [Form] 483 were given to the investigator during the close out meeting prior to the issuance of the FDA [Form] 483.” (Doc. 30, Exh. A17 at 7.)

The 2009 Form 483 and Chung’s response both mention an “HACCP Certificate” issued by the China Quality Certification Centre for “Processing of Arange [sic] of Roll Cabbage, Frozen Dumpling, Frozen Baozi, Frozen Chunjuan.” (Doc. 30, Exh. A17, Sub-Exh. 8-1.) The certificate states, “Qingdao Longyuanfa Food Co., Ltd.....is in compliance and continually operating with CAC/RCP1-1969 Rev. 4 (2003) Guidelines for the Application of the [HACCP] System.” (Id.)

Both the 2009 Form 483 and Chung’s response also refer to “Sanitary” and “Quality” certificates issued by the “Entry-Exit Inspection and Quarantine” authority in China, which include basic shipping information. (Id., Sub-Exhs. 8-3, 8-4.) Chung’s provided an additional certificate asserting that “Qingdao Shiping [sic] Package Co., Ltd., guarantee the ingredients of following package that are don’t contain leaded material, Will not hurt human health [sic].” (Id., Sub-Exh. 8-8.) Kujawa visited the facility in China and concluded that the Chinese facility was “in compliance and even exceeding usual U.S. food manufacturing plant standards.” (Id., Sub-Exh. 8-6.)

Chung’s states it “maintains at its location in Houston” documentation “for each shipment of imported Spring Rolls.” (Doc. 30, Exh. A17 at 7.) However, at the 2009 inspection, Chung’s did not provide the import documents for the most recent shipment. (Doc. 16, Exh. IF at 30.) Chung’s explained, “All of the records required by 21 C.F.R. § 123.9 are in fact retained at the processing facility in China. The investigator was advised of this fact during the inspection.” (Id.) Chung’s does not explain how these documents and or its endorsement of the facility in China satisfy the requirements of 21 C.F.R. § 123.9-12.

During the 2009 inspection, the FDA investigator documented fourteen instances of refusals by Chung’s to provide shipping documents as required by 21 U.S.C. § 374(a)(1), to allow taking of samples as required by 21 U.S.C. § 374(b), to disclose test results as required by 21 U.S.C. § 350c(a)(1), to permit observation of cooking facilities as required by 21 U.S.C. § 374(a)(1), to provide import documentation as required by 21 C.F.R. § 123.9, and to permit photography. See Dow Chemical v. United States, 476 U.S. 227, 106 S.Ct. 1819, 90 L.Ed.2d 226 (1986) (allowing photography by Environmental Protection Agency investigators and holding that “[w]hen Congress invests an agency with enforcement and investigatory authority, it is not necessary to identify explicitly each and every technique that may be used in the course of executing the statutory mission”); United States of America v. Acri, 409 F.Supp. 529 (S.D.Iowa 1976) (“[0]nce the validity of the inspection is established, the propriety of a photographic ‘search’ is coextensive with the validity of the inspection.”)

The FDA investigator also complained that Birdsell “personally impeded” the 2009 inspection by delaying the entry of investigators for over four hours on June 18, 2009. (Doc. 16, Exh. IF at 52.)

Chung’s did not address these refusals in its response to the Form 483. (Doc. 30, Exh. A17.) Kujawa denies that he refused to permit observation of cooking facilities. Kujawa quotes Chung’s minutes of the 2009 inspection: “After consultation with Mr. Kujawa, Mr. Birdsell granted the viewing.... [The inspection by Mr. Hurst continued in the Onion Room until complete, at 10.51 am.]” (Doc. 30, Exh. A at 24.) (brackets in original).

The FDA investigator, by contrast, reported,

On June 16, 2009, Mr. Greg Birdsell refused to allow me to observe the completion of the dehydrated onion cooking process. I was not allowed to observe the employee working in the dehydrated onion frying / cooking area moving the cooked product into the storage area within the normal working time frames of the facility. Mr. Birdsell stated that the onions would not be used in FDA products since the firm was producing USDA products. I was asked to leave the production area which I complied with immediately.

(Doc. 16, Exh. IF at 51.) Chung’s minutes state,

[The investigator] asked who does the labeling [of fried onions] and where it goes after cooling. Employee responsible for frying onions does the labeling, and it stays in onion cooler until the end of production at which time it is transported to the cooler. 10:51 — Once completed, Mr. Birdsell told the inspectors that they have seen the process and since it is a USDA production day, they would need to leave the production facility.

(Doc. 30, Exh. D2.) Kujawa implies that the investigator “continued [the investigation] until complete, at 10.51 am,” when, in fact, Birdsell expelled the investigators at 10:51. (Doc. 16, Exh. IF at 51; Doc. 30, Exh. D2.)

C. Clostridium Botulinum

Chung’s has a longstanding disagreement with the FDA over the inclusion of Clostridium botulinum (“C. botulinum”) in Chung’s HACCP plan. (Doc. 30, Exh. A4 at 2.)

Hazard Analysis Critical Control Points (“HAACP”) is a “systematic approach to the identification, evaluation, and control of food safety hazards” mandated for seafood processors since 1997. Fed. Drug Admin., Hazard Analysis and Critical Control Point Principles and Application Guidelines (1997). HACCP regulations require processors to keep food safety and sanitation records and make them available to FDA investigators. 21 C.F.R. §§ 123.9(c), 123.11(c).

C. botulinum is a bacterium that produces “the most potent toxin known to man,” causing the very rare but deadly disease botulism. (Doc. 16, Exh. 4 at 3; Id., Exh. 3 at 5.) C. botulinum proliferates in the viscera of shrimp and is more likely to appear in undeveined shrimp, which have intact digestive tracts or “veins.” (Doc. 16, Exh. 3 at 5.) Chung’s uses undeveined shrimp in its shrimp egg rolls. (Id.)

During each inspection from 2005 to 2009, the FDA investigator observed that Chung’s did not list C. botulinum as a Critical Control Point (“CCP”) in its HACCP plan. (Doc. 16, Exhs. 1H, 1G, ID, IB.) Listing a food safety hazard as a CCP obligates a processor to maintain safety records for that hazard. 21 C.F.R. § 123. Every hazard that is “reasonably likely to occur” based on the processor’s mandatory hazard analysis must be listed as a CCP. Id. Chung’s asserts that its decision not to list C. botulinum as a CCP was justified by its hazard analysis. (Doc. 30, Exh. A17 at 3.)

In 2009, the FDA investigator reported: During the close-out discussions with management, Mr. Birdsell and Mr. Kujawa both explained they did not agree with my inspectional findings.... They believed that the product does not have a hazard of Clostridium botulinum due to the history of the product and the in-house programs. Mr. Kujawa stated that his firm has a legal and correct HACCP plan for the production of his firm’s shrimp egg roll product. He explained that he was certified in HACCP and that I was not and that I did not understand HACCP.

(Id. at 53.) The Government’s expert witness, Michael Doyle (“Doyle”), director of the Center for Food Safety at the University of Georgia, questions the validity of Kujawa’s HACCP qualifications. (Doc. 16, Exh. 4 at 17.)

Doyle also questions the validity of Chung’s hazard analysis, which determined that C. botulinum is not a “reasonably likely” hazard in Chung’s egg rolls sold in Modified Atmosphere Packaging (“MAP”). (Doc. 16, Exh. 4 at 17.) MAP is “the packaging of a product in an atmosphere which has had a one-time modification of gaseous composition, rendering it different from air.” (Doc. 16, Exh. 3 at 9.) MAP is typically used for food sold in refrigerated deli or supermarket display cases, rather than freezers. (Id.)

[MAP] can extend the shelf life of fish and meat products at a reasonable cost by removing or reducing oxygen from the packaging.... Such packaging, however, presents a public health risk because it may not only extend shelf life, but also gives C. botulinum a chance to grow, with less or no competition from spoilage flora and no obvious signs of spoilage.

(Doc. 16, Exh. 4 at 5.)

Doyle states, “Chung’s failure to list C. botulinum as a food safety hazard leads me to question whether the firm understands HACCP, as a HACCP-certified individual familiar with C. botulinum, would list this as a hazard for a seafood-based product packaged in [Modified Atmosphere Packaging] that is to be sold at refrigeration temperature.” (Id.) Doyle does not address whether the hazard is “reasonably likely” as defined by 21 C.F.R. § 123.6(a).

After the 2005 inspection, the FDA instructed Chung’s that, if it chose not to follow the FDA’s Fish and Fisheries Products Hazards and Controls Guidance, it “must show a rationale for why the product is safe against Clostridium botulinum for the shelf life claimed, under conditions of mild abuse.” (Doc. 16, Exh. 2E at 3.) Chung’s responded that it would arrange a challenge study through the National Food Processors Association (“NFPA”) to test for C. botulinum in egg roll packages at different temperatures.

On February 21, 2006, Chung’s hired National Food Laboratory, Inc. to conduct the study, and it sent the FDA a copy of the testing protocol. (Doc. 30, Exh. A18.) On April 3, 2006, Chung’s wrote, “[T]he agency has never provided us with any comments concerning National Food Laboratory test protocol. Chung’s viewed this fact to mean the study protocol is not one to which [the] FDA would or will fault after the final results are known.” (Id.)

The challenge study detected C. botulinum in a sample stored for six days at 30°C, but not in a sample stored for twenty-eight days at 12°C. (Doc. 16, Exh. 3C.) Chung’s egg rolls were labeled for a twenty-eight day shelf life when kept in deli cases, which are typically maintained at approximately 10°C (50°F). (Doc. 16, Exh. 4 at 8.) However, all the samples “became overtly spoiled before toxin was produced.” (Doc. 16, Exh. 3C.) Chung’s asserted that the challenge study “confirms ... that C. botulinum is not reasonably likely to occur .... ” (Doc. 30, Exh. A4 at 5.)

The FDA raised several objections to the test results, including the possibility that C. botulinum growth had been inhibited by spoilage or competition between strains of inoculated C. botulinum, as well as the lack of a “positive control” for nonproteolytic strains of C. botulinum. {Id. at 2; Doc. 16, Exh. 3 at 16.) A positive control is a test sample in which bacterial growth occurs. Non-proteolytic C. botulinum is one of two major groups of C. botulinum:

The proteolytic group produce[s] enzymes that degrade proteins, causing offensive odors and tastes in a food product. Consumers therefore could smell or taste spoilage in food products contaminated with proteolytic C. botulinum. By contrast, the non-proteolytic group of C. botulinum which can grow at refrigeration temperatures as low as 38 degrees Fahrenheit may render a food toxic without any apparent signs of spoilage. Nonproteolytic strains, therefore, are particularly dangerous to consumers.

(Doc. 16, Exh. 3 at 6.) A positive control for non-proteolytic C. botulinum in the challenge study would have demonstrated that

selected strains of C. botulinum used to inoculate the egg rolls samples were capable of producing toxin in a component of the food. Once [toxin production is] shown, a positive control would then allow the laboratory to determine what attribute, for example, the egg roll formulation, controlled the production of toxin in the finished egg roll. Without a positive control, the Challenge Study does not reveal whether the laboratory was able to detect toxin in the food, nor does it reveal whether the product as formulated prevented the C. botulinum strains from producing toxin;

(Doc. 3 at 17.)

The National Advisory Committee on Microbiological Criteria for Foods (NACMCF), recommends using only nonproteolytic strains of C. botulinum to perform challenge studies on refrigerated foods. (Doc. 16, Exh. 3 at 17.) The challenge study performed by National Food Laboratory, however, employed a mixture of proteolytic and non-proteolytic strains of C. botulinum that “may have competed with each other to prohibit toxin growth.” (Id. at 17; Doc. 16, Exh. 3C.) Doyle, the Government’s expert, explains,

This study is flawed for many reasons. First, the study does not make clear whether C. botulinum strains used by [National Food Laboratory] could grow and produce toxin, ie. a positive control was lacking. Accordingly, it is unclear whether toxin was not produced in the egg rolls because the egg rolls are for-: mulated in a way that prohibits the growth, or because the strain used would not have produced the toxin under any conditions. The purpose of a positive control for such studies is to ensure that the C. botulinum culture used to inoculate the food is viable and able to produce detectable concentrations of botulinum toxin. It confirms that the test is functioning properly.

(Doc. 16, Exh. 4 at 15.)

In response to the FDA’s objections, National Food Laboratory stated that “[viability of ... C. botulinum is checked by platting [sic] the inoculum.... There is not a ‘product positive control’ since the question we are trying to answer with the study is, will C. botulinum grow (remain viable), and produce toxin?” (Doc. 16, Exh. 3D at 3.) “Plating” is a method of preparing inoculum in food studies by placing a small amount of bacteria on an agar plate, from which healthy portions are extracted, analyzed, and then injected into a food sample, such as a positive control sample. Fed. Drug Admin., Bacteriological Analytical Manual ch. 17 (1998).

“Checking] the viability of C. botulinum by platting [sic] the inoculum” does not address the FDA’s criticism whether “the selected strains of C. botulinum used to inoculate the egg rolls samples were capable of producing toxin in a component of the food, ” nor does it “reveal whether the product as formulated prevented the C. botulinum strains from producing toxin.” (Doc. 16, Exh. 3 at 17 (emphasis added).) It is possible that culturing C. botulinum in an egg roll sample, as a positive control sample, would require adjusting factors such as acidity, water activity, or salt. Fed. Drug Admin., Bacteriological Analytical Manual ch. 17 (1998). This would add a layer of sophistication to the experimental design, beyond what might be typical of food challenge studies. Nevertheless, the lack of a positive control remains a valid criticism. Rather than address the challenge study’s limitations, Chung’s insisted it was valid and that the results justified Chung’s decision not to list C. botulinum in their HACCP plan. (Doc. 30, Exh. A4 at 5.)

Unexpectedly, the challenge study found indications of spoilage prior to the egg rolls’ use-by date. (Doc. 16, Exhs. 4 at 15, 3D at 6.) At twenty days, lobster egg rolls stored at 12°C (50°F) showed signs of spoilage, including off odors and mold. (Doc. 16, Exh. 3C.) Shrimp egg rolls showed signs of spoilage at twenty-eight days. Doyle stated,

As a matter of industry best practice, [Chung’s] should have altered its shelf life based on this study; if the product had signs of spoilage within twenty days at temperatures that occur in the home or at retail, the shelf life of the products should be less than twenty days, not the twenty eight days that the firm currently uses.

(Doc. 16, Exh. 4 at 15.)

Chung’s subsequently reduced the labeled shelf life of its lobster egg rolls to twenty-one days, one day longer than the twenty days indicated by the study. (Doc. 16, Exh. ID.) Two years later, Chung’s discontinued its lobster egg rolls. (Doc. 16, Exh. IF at 54.) Chung’s continues to sell shrimp egg rolls with a labeled shelf life of twenty-eight days, a duration in which spoilage was observed. (Doc. 16, Exhs. ID, IF at 10.)

In 2009, Chung’s changed the formulation of its egg rolls. (Doc. 30, Exh. A17 at 6.) Doyle testifies:

Chung’s has altered its formulation at least two times since the Challenge Study ... by using cooked rather than raw frozen shrimp ..'. [and] switching] from raw onions to dehydrated onions. Either of these changes could have substantially altered the aerobic spoilage flora of the product which compete with C. botulinum. ... Because of these changes, the Challenge Study, which was flawed when originally conducted, cannot be relied on by the firm currently-

(Doc. 16, Exh. 4 at 16.) Prior to the change in product formulation, Chung’s had told the FDA

[i]f Chung’s were to change the formulation of the product this Challenge Study would not be applicable to that new formulation .... Should Chung’s in the future determine to change ingredients in its egg roll products, it is logical to have [National Food Laboratory] or some similar qualified testing laboratory conduct another Challenge Study to verify that C. botulinum continues to not be an issue. This notation will be in the HACCP plan at Chung’s to make sure no problems arise in the future.

(Doc. 16, Exh. 3D at 4.)

At the meeting in 2008, “[i]n response to a question from [the FDA] about changing onions over the course of time, Mr. Kujawa said that Chung’s only used onions that are not sweet to maintain an even product.” (Doc. 16, Exh. 2C at 3.) During the meeting, the FDA and Defendants discussed “how holding to a formulation is a key to consistent product without continually changing the formulation and then having to consider another Challenge Study. Mr. Kujawa and Mr. Birdsell mentioned that each ingredient in the egg rolls has precise specifications that are provided to all vendors.” (Doc. 16, Exh. 2C at 3.)

During the 2009 inspection, the FDA investigator observed that Chung’s had, in fact, switched to dehydrated onions. (Doc. 16, Exh. IB.) When the investigator inquired why Chung’s had not informed the FDA of the change, Birdsell said “recipe information is confidential and proprietary.” (Doc. 30, Exh. D2.) The Product Specification sheet for Chung’s shrimp egg rolls, dated February 2008 and presented to the FDA in August 2009, indicates that “[fjresh vegetables are peeled and washed,” but does not mention dehydrated onions. (Doc. 16, Exh. A17, Sub-Exh.8-7.) Chung’s also failed to list the change of ingredients on its HACCP Updates chart. (Doc. 16, Exh. IF at 54.) On April 21, 2009, Chung’s made seven entries to its HACCP Updates chart, including entries for discontinuing egg rolls containing lobster and outsourcing the mixing of spices but not including the change in onions. (Doc. 30, Exh. A17, Sub-Exh. 5.) Chung’s stated:

At the time Chung’s determined to modify the make-up of MAP Shrimp egg rolls by switching from fresh onions to dried onions the HACCP was in fact followed. While formula change information is confidential and proprietary, the water activity [i.e., moisture content, a barrier for C. botulinum in food products] of Shrimp egg rolls was monitored before the change, during the change and following the formula change.

(Doc. 30, Exh. A17 at 6.) Chung’s testing records indicate that water activity levels in its egg rolls were tested on February 26 and again on May 7, 2009. (Id., Sub-Exh. 7.) However, there is no indication whether these tests occurred “before the change, during the change [or] following the formula change.” (Doc. 30, Exh. A17 at 6.) The FDA investigator reported in June 2009, “There is no way to tell when the change in the process occurred. There is no documentation of the ingredient change in any of the firm’s HACCP documents that were provided during the inspection.” (Doc. 16, Exh. 1F at 29.)

During the 2008 meeting, an FDA official noted that “a change in suppliers might have a cascade effect requiring additional Challenge Studies.” (Doc. 16, Exh. 2C at 3.) The Government’s expert, Doyle, testifies:

Changing the producer of shrimp, depending on its source, may also require a new Challenge Study because the source of the shrimp could use raw chicken manure and fish waste as nutrients in ponds and have a higher prevalence and concentration of C. botulinum type E spores than shrimp grown in open water.

(Doc. 16, Exh. 4 at 16.) Chung’s states that it “do[es] not think a specific vendor plays any role.” (Doc. 30, Exh. 3D at 4 n. 1.)

Chung’s claims to have extensively researched different egg roll formulations to control C. botulinum, including by using ingredients such as nisin and acid. (Doc. 30, Exh. A18 at 3.) At the same time, Chung’s insists that its “egg roll ingredients are all typical food ingredients with a formulation that has not changed for years.” (Doc. 16, Exh. 3D at 5 n. 1.)

Chung’s fails to demonstrate that it retested its egg rolls or reassessed its HACCP plan upon making changes to its formula, suppliers, or ingredients.

D. Water Activity as a Secondary Barrier for C. Botulinum

The FDA’s Fish and Fisheries Products Hazards and Controls Guidance recommends that MAP-packaged fish and fishery products have a “secondary barrier” to prevent growth of C. botulinum, in addition to the primary barrier, temperature, which is maintained through refrigeration. (Doc. 16, Exh. 4 at 11.) The FDA’s Guidance is not compulsory. “An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.” (Id. at 1; Doc. 16, Exh. 3 at 15.)

Recommended secondary barriers for C. botulinum include “controlling the level of pH to 5 or below, salt to 5% wps or more, moisture (water activity) to 0.97 or below, or some combination of these barriers.” Fed. Drug Admin., Fish and Fisheries Products Hazards and Controls Guidance 250 (4th ed. 2011). “MAP packaging itself is not such a barrier; rather it is a risk because it is what promotes C. botulinum toxin formation by creating a long-term reduced oxygen or anaerobic environment.” (Doc. 16, Exh. 4 at 11.)

Water activity is a measure of the moisture content of food, measured on a scale of zero to one, with pure water having a level of one. (Doc. 16, Exh. 3 at 14.) Foods with a level of 0.85 or less, such as dried fruits or nuts, do not support pathogenic bacteria and can be stored without refrigeration. (Doc. 16, Exh. 3 at 14.) The FDA has determined that a water activity level of 0.97 or below may serve as a secondary barrier for C. botulinum. (Id.; Doc. 30, Exh. C at 6.)

In response to the FDA’s 2007 warning letter, Chung’s requested a meeting with FDA officials at the FDA’s Center for Food Safety and Applied Nutrition (“CFSAN”) in Maryland. (Doc. 30, Exh. A8.) At the meeting, “Chung’s stated that it would control for the risk of C. botulinum by monitoring the water activity of its shrimp egg rolls and ensuring that this level was maintained below 0.97.” (Doc. 16, Exh. 2 at 5.) Chung’s minutes state:

[Chung’s attorney] announced that very recently Chung’s had conducted water activity testing of its [shrimp egg rolls] and that the results were water activity of less than 0.97. The significance of this result is Chung’s has demonstrated it has a secondary barrier to these products as provided for in FDA Guidance, Fish and Fisheries....

Mr. Kujawa explained that only recently had he become aware of the fact that Chung’s had not previously tested its egg rolls for water activity. He had experience with water activity while working in the food industry and decided to have the tests run. Mr. Kujawa stated Chung’s would monitor water activity each day that shrimp and seafood egg rolls are produced for three months to verify the level is consistently below 0.97, and then monitor quarterly going forward. This was agreeable to the agency-

(Doc. 16, Exh. 2C at 3.)

Consumer safety officer Mary Losikoff (“Losikoff’) of CFSAN testifies, “This promise was a step in the right direetion[;] however, as demonstrated during the 2009 inspection, [Chung’s] failed to live up to this promise and has yet to include water activity as a critical control point in its HACCP plan....” (Doc. 16, Exh. 3 at 24-5.) Kujawa responds, “Contrary to the statements by Ms. Losikoff ... not one word was said by any FDA official present at the 2008 meeting that additionally Chung’s should list [w]ater activity as a critical control point (CCP) in ... Chung’s HACCP plan.” (Doc. 30, Exh. A at 11.)

During the 2009 inspection, the FDA investigator sent samples of Chung’s shrimp egg rolls to the FDA’s laboratory for water activity testing. Levels ranged from 0.975 to 0.982, averaging 0.979. (Doc. 16, Exh. 2D.) Chung’s claims it sent identical samples to a private laboratory for testing. (Doc. 30, Exh. All.) Two of Chung’s samples had water activity levels of 0.976, although the average levels were lower. (Id.) Chung’s attorney noted:

The results of the two tests are not the same.... An examination of the samples side by side fails to disclose any consistent differences. For example, in sample no. 4 the FDA laboratory reported the highest water activity, 0.982 while [the private laboratory] reported the sample pulled at the same time and place to have a water level activity of 0.968, the third lowest reading by [the private laboratory].

(Id.) The investigator reported that “due to the discrepancy between [Chung’s] own water activity results and the sample that I collected during the inspection, Mr. Bird-sell and Mr. Kujawa stated [that] changes to the shrimp egg roll product are under research and development by the firm.” (Doc. 16, Exh. IF at 26.) Defendants do not dispute that Chung’s egg rolls tested above 0.97 in both Chung’s and the FDA’s tests.

During the 2009 inspection, the FDA investigator reviewed results of voluntary water activity tests undertaken by Chung’s since the 2008 meeting, noting three instances when levels exceeded 0.97. (Id. at 23.) The investigator also reported that Birdsell and Kujawa refused to allow photocopying of Chung’s water activity testing records. (Doc. 16, Exh. IF at 51.) Bird-sell and Kujawa protested the taking of samples for testing and prevented the investigator from leaving the facility with the samples without first issuing a Form 484 receipt, which impeded taking routine random samples. (Doc. 16, Exh. IF at 51.) A Form 484 receipt is typically issued along with the Form 483 at the end of each inspection. Fed. Drug Admin., Investigator Operations Manual § 5.2.4 (2011).

After the 2009 inspection, Chung’s attempted to preempt the issuance of a Form 483 containing any observation of its failure to include water activity as a secondary barrier for C. botulinum in its HACCP plan. (Doc. 30, Exh. All at 2.) Chung’s warned:

If there is a[n] FDA [Form] 483 observation on the water level activity issue Chung’s will respond by contesting the findings of your Denver laboratory, contest what the actual definition of [a water activity level] above 0.97 means, and return to the dispute we have over the agency’s attempt to use Guidance as though it were binding law. The resolution of those issues will require considerable resources of all concerned.

(Id.)

Chung’s expert, Bluhm, questions whether 0.97 is an appropriate level for water activity, based on research relating to C. botulinum type E:

I went back to FDA Guidance to confirm that the level of Water Activity suggested as a goal is 0.970. My research, however, shows that [ ] number is much higher than what is realistically required to effectively and safely protect the pub-lie.... Hobbs (1976) stated that at 10°C and at the optimum pH for growth, C. botulinum type E was inhibited by [a water activity level] of 0.990. I understand my conclusion that [a water activity level] of 0.990 is acceptable and safe is different than the FDA Guidance [water activity level] of 0.970 ....

(Doc. 30, Exh. C at 6.) In fact, the research cited by Bluhm is referenced by the FDA in its Guidance. Fed. Drug Admin., Fish and Fisheries Products Hazards and Controls Guidance app. 7 (3d ed. 2001).

Bluhm provides no other evidence contradicting the FDA’s Guidance level of 0.97. According to his curriculum vitae, Bluhm has not published any research in this area. (Doc. 30, Exh. Cl.) By contrast, the Government’s expert, Doyle, has written over 250 peer reviewed articles and fifty-three book chapters relating to food-borne pathogens, including widely cited research on controlling C. botulinum in MAP-packaged food products. (Doc. 16, Exh. 4.)

E. Listeria Monocytogenes

Chung’s disagrees with the FDA about the presence and control of Listeria monocytogenes (“L. mono”) at its plant.

L. mono is a bacterium that tends to proliferate in moist niches such as floor drains and surfaces with condensation; it causes the rare but deadly disease listeriosis. (Doc. 16, Exh. 3 at 6.)

In 2005, the FDA detected L. mono in five different environmental swab samples at Chung’s plant. (Doc. 16, Exh. II.) The FDA investigator observed that Chung’s did not properly monitor the temperature and heat penetration of fried egg rolls to control growth of L. mono. (Doc. 16, Exh. 1H.)

In January 2006, Chung’s informed the FDA that it had purchased a new fryer with temperature and speed monitors and that it planned to hire an outside tester to check for cold spots to determine the temperature and speed settings necessary to achieve the required heat penetration. (Doc. 16, Exh. 2E at 4.) In the meantime, Chung’s promised to perform in-house L. mono testing on four to eight egg rolls per production run. (Id.)

In June 2006, the outside tester determined that the egg rolls did not achieve adequate heat penetration within the fryer, although adequate heat penetration occurred outside the fryer, as the egg rolls were carried on a conveyor belt toward the freezer. (Doc. 16, Exh. ID at 5.) On August 7, 2006, the FDA informed Chung’s that the test report “appears adequate,” on the condition that Chung’s “add a dwell time requirement in the chill tunnel” to ensure proper cooking. (Doc. 16, Exh. 3D at 7.) Chung’s responded that “a dwell time requirement will be added for the chill temperatures” and that it would designate “an appropriate point in the chill tunnel to monitor [the] product coming from the fryer to confirm that the temperature of the egg rolls” meets guidelines. (Doc. 16, Exh. 3D at 7.)

During the next inspection, in May 2007, the FDA investigator observed, “The [heat penetration] study states that the minimum [reduction in egg roll temperature, according to FDA guidelines] is achieved 10 minutes after the egg roll exits the fryer. There is [sic] no data listing the temperature of the product at ten minutes outside of the fryer.... The temperature of the chill room is not being monitored.” (Doc. 16, Exh. ID at 6.) The investigator also observed that the temperature of the chill room had “dropped as much as 40 degrees [Fahrenheit] since the study was conducted.” (Id.) On October 30, 2007, the FDA issued a warning letter designating the temperature deviation a “significant violation.” (Doc. 16, Exh. 2A.) In December 2007, Chung’s announced that it would change its monitoring process. (Doc. 30, Exh. A4 at 6.) According to Chung’s minutes of a meeting in March 2008, an FDA officer questioned the adequacy of the new monitoring process but ultimately agreed that it was adequate. (Doc. 30, Exh. A8 at 3.) The FDA officer pointed out that the heat penetration test itself was “sufficient to validate the fryers.” (Id.)

At the next inspection, in 2009, the FDA investigator reported, “Mr. Birdsell stated that they threw out the study and they are not using it.” (Doc. 16, Exh. IF at 33.) The investigator determined that the new monitoring process could nonetheless be validated by the study and chose not to include the issue again as an observation on the Form 483, “even though [Chung’s] has decided to ignore the findings and not reference the document to validate [its] cooking process.” (Id.)

Also during the 2009 inspection, the FDA investigator again took environmental samples and, as in 2005, found L. mono in multiple locations. (Doc. 16, Exh. IE.) The samples were sent to the FDA’s Denver District Laboratory for a DNA test, and digital images of the bacteria’s DNA fingerprint were then sent to CFSAN in Maryland. (Doc. 16, Exh. 5 at 4.) An analyst at CFSAN compared them to the DNA fingerprint patterns from the 2005 samples and identified “a common strain of L. mono present in the Chung’s plant that persisted from 2005 to 2009.” (Id.) Both the 2005 and 2009 samples also tested positive for non-hazardous species of Listeria, including Listeria innocua and Listeria welshimeri, as did concurrent samples taken by Chung’s. (Doc. 30, Exh. B at 6.)

Chung’s expert, Bluhm, challenges the significance of these other Listeria species. (Doc. 30, Exh. C at 10.) “L. innocua is widespread in the environment and in food is considered to be a nonpathogenic bacterium. More to the point, one positive L. innocua result is not alarming and is certainly no reason to enter a permanent injunction. The same can be said for L. welshimeri.” (Id.)

Consumer safety officer Losikoff of CFSAN testifies:

Positive results for the presence of non-pathogenic forms of Listeria species (“L. spp. ”), such as L. innocua, in a production environment alerts a processor to the potential contamination of ready-to-eat product during processing because, generally, L. spp. is more easily detected than L. mono. Accordingly, the seventeen environmental swabs that tested positive for L. innocua are significant, and suggest that conditions also are suitable for survival and/or growth of L. mono.

(Doc. 16, Exh. 3 at 22.) The Government’s expert, Doyle, agrees:

The positive L. mono findings along with seventeen positive samples of L. innocua (another strain of Listeria that thrives under the same conditions as L. mono and is considered an indicator of potential L. mono contamination) suggest that these listeriae are widespread in Defendants’ processing environment and must be controlled to ensure production of a safe food product.

(Doc. 16, Exh. 4 at 20.)

Chung’s responds that the positive L. mono test results may have been caused by flawed collection practices. (Doc. 30 at 15.) Kujawa and Birdsell list many examples of possible cross-contamination during the sample collection process. (Doc. 30, Exh. A at 16, Exh. B at 11.) For instance, Birdsell accuses the FDA investigator of “touching his glasses and his nose” while holding a sample that tested negative for salmonella. (Doc. 16, Exh. B at 11.) Defendants cite only one example of possible cross-contamination involving a sample that tested positive for L. mono. In this instance, the FDA investigator, prior to taking the sample, put on gloves from a bag that had come into contact with another bag he had picked off the floor. (Id.) However, Defendants do not allege that the gloves touched either bag or the surface of the sample.

Chung’s also questions the integrity of the samples during transport and processing by the FDA:

The Government did not provide an evidentiary foundation for the alleged positive L. mono results from 2005 and 2009. The Government’s summary judgment evidence is silent regarding the chain of custody of the samples, the tests performed on the samples, the qualifications of the technicians that tested the samples, and the validation of the laboratories in which the samples were tested.

(Doc. 30 at 14.) These items, however, are documented in the FDA laboratory’s reports as well as the FDA investigator’s report. (Doc. 16, Exhs. IE, 5B, and IF at 53.) Chung’s expert witness does not mention Kujawa’s and Birdsell’s criticisms of the investigator’s sampling protocol, aside from remarking, “I do not find anything stated by [the investigator] on how in 2005 or 2009 the collected samples were handled, chain of custody verified, and when the samples were tested.” (Doc. 30, Exh. C at 11.)

There is disagreement between Defendants and the FDA about whether the L. mono test results were disclosed during the 2009 inspection. Chung’s contends that the FDA’s test results are suspect due to belated disclosure. (Doc. 30 at 14.) “There is no reason why the FDA would not provide timely notice of this claim— unless there were serious problems with the FDA’s samples or test results.” (Id.) The FDA investigator reported:

I explained during the close-out of the inspection that the environmental samples that I collected on June 18, 2009 were both positive for Listeria monocytogenes and Listeria innocua.... I explained to both Mr. Birdsell and Mr. Kujawa that they should reevaluate their sanitation program due to the amount of positive samples that were collected during the inspection.

(Doc. 16, Exh. IF at 38.)

Kujawa and Birdsell deny this version of events. Birdsell states that the investigator “never told me — or said in my presence — that the FDA laboratory testing in 2009 revealed the presence of L. mono in the Chung’s facility. My memory is consistent with the contemporaneous notes taken by Chung’s diming the inspection, which do not reflect this alleged conversation.” (Doc. 30, Exh. B at 12.) Kujawa testifies:

At no time did [the FDA investigator] in my presence say that FDA had discovered the presence of L. mono in the Chung’s facility in 2009. I know it did not happen (1) because of my memory of the event, (2) because if it had happened I would have instructed Gregory Bird-sell, Chung’s Director of Quality Assurance, to immediately implement our L. mono protocol and there would be a record of that event, (3) because Mr. Birdsell was present at the closing meeting and he recalls no such discussion, and (4) and perhaps most importantly, that discussion does not appear in the contemporaneous notes take by [Chung’s employees] Shannon Trahan and Monica Patterson of what occurred and was said during the inspection by FDA and Chung’s.... I have read the notes and they contain absolutely no mention of [the investigator] speaking of L. mono being present at the close out meeting when he issued the FDA 483.

(Doc. 30, Exh. A at 14.) However, Chung’s minutes of the closing meeting, on which Kujawa and Birdsell rely, suggest that L. mono results were, in fact, disclosed:

12:58 FDA asked about Chung’s test results for the environmental samples. Mr. Birdsell said they came back 100 percent clear.

FDA claims they found L. innocua in some areas.

1:07 [The investigator] says the sanitation program is not working because two drains in the plant did not come back with good test results. Mr. Kujawa said we had Listeria species, but not Listeria monocytogenes.

(Doc. 30, Exh. D2.) “Two drains” refers to the location of the two samples where L. mono was detected, in contrast to “some areas” where L. innocua was found. (Doc. 16, Exh. IE at 3.) Read in context, Chung’s minutes strongly suggest it was aware of the positive L. mono test.

F. Staphylococcus Aureus

Chung’s and the FDA disagree about the control of Staphylococcus aureus (“S. aureus”) in Chung’s facility. In 2005 and again in 2007, the FDA investigator observed that S. aureus was not included as a CCP in Chung’s HACCP plan. (Doc. 16, Exhs. 1H at 3 and ID at 5.) During the 2006 inspection, the FDA investigator observed employees repeatedly “placing hand-rolled egg rolls into a large unrefrigerated tank of batter in an assembly line.... Defendants did not routinely wash or sanitize this batter tank, and the temperature of the batter in the tank reached as high as 74 degrees Fahrenheit.” (Doc. 16, Exh. 3 at 22.) S. aureus growth may occur at temperatures above 70 degrees. (Id.) The investigator also observed that Chung’s employees failed to monitor the temperature. (Id.)

In its response to the 2006 Form 483, Chung’s asserted that, since the inspection, employees had been retrained and backup monitors assigned. (Doc. 30, Exh. A19 at 5.) A batch of 7200 egg rolls from the day the FDA investigator observed the noncompliance was subsequently “held” by Chung’s, tested for S. aureus, and then released for sale. (Id.)

Losikoff testified:

In 2007, after Chung’s had been cited twice for issues regarding the S. aureus hazard in its batter, rather than institute proper sanitation procedures, the firm disregarded batter temperature as a critical control point and removed batter temperature from its HACCP plan.... In 2009, [the] FDA observed that the firm was no longer using batter or dip buckets, however, because it has not instituted proper procedures or controls, there is nothing to prevent a restart of the same or similar insanitary practices.

(Doc. 16, Exh. 3 at 23.) Bluhm states, “I inspected the Chung’s facility for several days in April 2010 and based upon my inspection and review it is my opinion that Chung’s sanitation practices are adequate and that S. aureus is not a real risk or problem.” (Doc. 30, Exh. C at 12).

G. Metal Detection

From 2005 to 2009, the FDA investigator observed that Chung’s did not include metal detection as a CCP in its HACCP plan. (Doc. 16, Exhs. IB, 1H, ID.) Chung’s HACCP plan stated:

Process Step: Metal Detection Potential Hazard Introduced, Controlled Enhanced or Reduced at This Step: None identified at this time.

Is The Potential Food Safety Hazard Reasonably Likely To Occur?: No Justification For Decision: None What Control Measures Can Be Applied To Prevent The Significant Hazard(s)?: None

(Doc. 16, Exh. IB at 3.)

During the 2007 inspection, the FDA investigator observed a broken blade on a carrot slicer. (Doc. 16, Exh. ID at 5.) Defendants responded that “it is very unlikely that metal would enter the product.” (Id.) Chung’s used a metal detector in its assembly line, as part of an in-house program for which no documentation is required. (Doc. 16, Exh. IB.) Finally, in 2009, Chung’s announced that it would list metal detection as a CCP. (Doc. 30, Exh. A17 at 5.)

H. USDA Inspection

In January 2010, the USDA completed a four-year comprehensive assessment of the production of chicken and pork egg rolls in Chung’s facility and concluded that Chung’s “is capable and is producing a safe product.” (Doc. 16, Exh. A12 at ¶ 4.) The USDA investigator reported that Chung’s “maintains very high standards with regard to sanitation practices.” (Doc. 16, Exh. A12 at ¶ DJ7.)

On January 13, 2010, the USDA collected environmental swabs that tested negative for L. mono. (Doc. 30, Exh. A12 at 5.) The date the USDA planned to take samples was announced in advance. (Id. at 8.)

In contrast to the FDA’s assessment, the USDA investigator found that “all hazards reasonably likely to occur [were] identified” in Chung’s hazard analysis. (Doc. 30, Exh. A12 at II1.) Procedures not included in its HACCP plan, such as Chung’s “in-house program” to control C. botulinum by monitoring water activity, “are supporting and maintaining conditions for justification of hazards made in the hazard analysis.” (Id. at ¶ H4g.) However, the USDA assessment mentions sixteen incidents of noncompliance from July 2010 to January 2011, involving “HACCP monitoring and execution” as well as sanitation problems. (Id. at 5.) The incidents of noncompliance involving sanitation included “food particles observed on food contact surfaces during pre-operational inspection and condensation issues observed during operational sanitation inspection.” (Id.) The incidents “did not impact the establishment’s ability to produce unadulterated product.” (Id.) The investigator noted that “Mr. Birdsell and Mr. Kujawa were thanked for their cooperation and patience throughout the process of the [USDA inspection].” (Id. at 9.)

I. Chung’s Independent Efforts to Comply

In April 2010, Chung’s hired Bluhm to conduct an inspection. He testified:

Based upon my professional experience as the Director of Field Programs at FDA, my knowledge of sanitation matters in food processing, my personal eyes-on inspection of the Chung’s facility, my conversations with Chung’s personnel, my review of the documents provided to me and under all the circumstances of this matter as more fully described below, I have come to the conclusion that the entry of a permanent injunction sought by the government in this case is not warranted with respect to MAP or general sanitation issues. I also conclude that Chung’s has not ignored or failed to cooperate with the FDA such as to warrant the requested injunction.

(Doc. 30, Exh. C at 3.) Bluhm noted that “this is not to say that everything Chung’s has done or is doing is perfect.... During my inspection of the facilities I did make several observations of conditions that, if changed, would reduce a potential sanitation problem.” (Doc. 30, Exh. C at 4.) However, Bluhm asserted that

it is extremely difficult to accept the statements ... that Chung’s does not pay attention to items on the 483s and that they, Chung’s, will revert back to procedures predating the 2007 [inspection report] and attendant 483s.... There have been numerous changes to the facility, protocols and procedures over the years as well as positive changes in the personnel of the company. The plant and procedures/protocols followed and existing today in no way resembles that which was in place last year and certainly that which was existent from 2005-07 [sic].

(Id. at 10.)

The Government disputes Chung’s “claim[s] to have taken steps to correct deficiencies” and argues that Defendants “cannot or simply will not implement a consistent and permanent system of competent practices on their own.” (Doc. 34 at 17.)

After the FDA first documented the C. botulinum issue in 2005, Chung’s explored various alternative methods for reducing the risk without listing C. botulinum as a CCP. (Doc. 16, Exh. 2E at 4.) No alternative methods were implemented. In January 2006, Chung’s reported that it

experimented with a number of different ingredient formulation changes attempting to create an acceptable (i.e. marketable) secondary barrier, but that to date none of the changes resulted in a product that would make it from an esthetical point of view in the market. One common formula change to create a secondary barrier was the addition of acid to the recipe. [Chung’s vice president for research and development] Mr. Novak stated the result was the product with acid added tasted terrible. Chung’s would lose customers because of the bad taste. [Chung’s director of quality assurance] Ms. Ybarra said adding acid makes the product taste ‘pickled.’

(Id.) In April 2006, Chung’s reported,

Since our January 2006 meeting Chung’s has been fortunate to locate an expert in food safety who by happenstance is a faculty member at the University of Houston.... Chung’s is considering a project with the professor to demonstrate the second barrier properties of nisin in MAP refrigerated egg rolls as well as its impact on the taste and aroma of egg rolls.

(Doc. 30, Exh. A18.)

By May 2006, Chung’s had shifted its approach from researching ways to comply with FDA observations to validating its current formulation of egg r