October 2012

This case has saved a lot of illnesses and deaths in consumers of ground beef over the last two decades.  It has also saved the beef industry – although it likely would not admit it.

It is worth the full read.

I. BACKGROUND

On October 17, 1994, the United States Department of Agriculture (“USDA”) announced a new Escherichia Coli O157:H7 (“E. Coli”) sampling program, to be conducted by the Food Safety and Inspection Service (“FSIS”). The notice announced that the FSIS would collect and test five thousand (5,000) samples of raw ground beef from federally inspected establishments and retail stores. Any of these samples testing positive for the pathogen E. Coli would be treated as “adulterated” under the Federal Meat Inspection Act (“FMIA”) and referred to FSIS headquarters for regulatory action.1 Prior to this announcement, the USDA had treated pathogen-contaminated2 meat as unadulterated under the FMIA.

On November 1, 1994, several supermarket and meat-industry organizations3 brought this action seeking to prevent the USDA from conducting its E. Coli sampling program. Plaintiffs argue that the USDA failed to adhere to the notice-and-comment procedure required by the Administrative Procedure Act (“APA”) and move this Court for a temporary and permanent injunction. Plaintiffs also contend that the sampling program is an arbitrary and capricious exercise of agency authority and that it exceeds the USDA’s statutory authority under the FMIA.

II. FINDINGS OF FACTS AND CONCLUSIONS OF LAW

In order to obtain a preliminary injunction, the Fifth Circuit requires the movant for a preliminary injunction to prove the following four elements:

(1) a substantial likelihood of success on the merits; (2) a substantial threat of irreparable injury if the injunction is not issued; (3) that the threatened injury to the movant outweighs any damage the injunction might cause to the opponent; and (4) that the injunction will not disserve the public interest.  Lakedreams v. Taylor, 932 F.2d 1103, 1107 (5th Cir.1991); see also Enterprise International, Inc. v. Corporacion Estatal Petrolera Ecuatoriana, 762 F.2d 464, 471 (5th Cir. 1985). If the movant fails to sufficiently prove any of these elements, the preliminary injunction should be denied.

In evaluating the first element, whether there is a substantial likelihood of success on the merits, the nature of the Plaintiffs complaint must first be determined. Plaintiffs do not contest that the USDA has statutory authority to conduct sampling and testing; however, Plaintiffs do attack the USDA’s E. Coli sampling program because it treats E. Coli as an adulterant under the FMIA. Plaintiffs claim that the USDA’s decision to treat E. Coli as an adulterant should be enjoined because it 1) violates the APA 2) is arbitrary and capricious and 3) exceeds USDA’s statutory authority. The Court will address each of these arguments in turn.

A. Violation of the APA

Under the APA, government agencies may issue rules only after the notice-and-comment procedures enumerated in the statute are completed. 5 U.S.C. § 553. It is undisputed that the USDA’s sampling program was promulgated without engaging in those procedures. However, USDA argues that notice-and-comment requirements do not apply in this case by virtue of § 553(b)(3)(A) which carves out an exception for “interpretive rules, general statements of policy, or rules of agency organization, procedure, or practice.” 5 U.S.C. § 553(b)(3)(A). According to USDA, its E. Coli sampling program is nothing more than an inspection program which qualifies as a “procedural rule” under § 553(b)(3)(A). In the alternative, USDA argues that its decision to consider E. Coli an adulterant under the FMIA is an interpretive rule intended to advise the meat and grocery industries of the agency’s position on the law.4

In determining whether an agency’s action requires notice-and-comment, courts have recognized that there are no bright-line rules used to determine whether an agency’s action fits into one of the enumerated exceptions. E.g. Avoyelles Sportsmen’s League, Inc. v. Marsh, 715 F.2d 897, 909 (5th Cir. 1983) (stating that the “categories have `fuzzy perimeters’ and establish `no general formula'”) (citations omitted). Rather, “it has fallen to the courts to discern the line through the painstaking exercise of hopefully, sound judgment.” Community Nutrition Institute v. Young, 818 F.2d 943, 946 (D.C.Cir.1987).

In the present case, the process is further complicated because the agency action in question, is actually comprised of two distinct parts. The first component is the agency’s decision to test raw ground beef for the E. Coli pathogen and the second is its decision to treat E. Coli contaminated meat as “adulterated” under the FMIA.5

As for the first part, it appears to be undisputed that USDA has the authority to test for E. Coli without engaging in notice-and-comment rulemaking.6 The FMIA authorizes the USDA to conduct testing and this aspect USDA’s announcement appears to be a “procedural rule” in that it merely informs the industry of the procedures it will use to conduct this testing. Furthermore, in determining whether a rule is in fact procedural, the real inquiry has been described as whether a rule will have a “substantial impact” on those regulated. Brown Express, Inc. v. United States, 607 F.2d 695, 702 (5th Cir.1979). Since the testing program is conducted and funded by FSIS, it does not compel any specific industry action. In fact, there is nothing about the agency’s decision to test for E. Coli, by itself that imposes any kind of burden on the industry. Therefore, USDA was not required to conduct notice-and-comment procedures before implementing its plan to test raw ground beef for E. Coli. See U.S. Dept. of Labor v. Kast Metals Corp., 744 F.2d 1145, 1151-52 (5th cir. 1984) (holding that an inspection plan properly fit the “procedural rule” exception to the notice-and-comment requirement of the APA).

The more difficult question is whether the second part of USDA’s announcement, its decision to treat E. Coli as an adulterant, violated the APA’s notice-and-comment requirement. The Court agrees with the Plaintiffs that this decision may have a substantial impact on the regulated industry. Therefore, it does not qualify as a “procedural rule.” Furthermore, the USDA’s announcement does not appear be a “general statement of policy.” See, e.g., Brown, 607 F.2d at 701 (describing general statements of policy as “announcements to the public of the policy which the agency hopes to implement in future rulemakings or adjudications. A general statement of policy like a press release, presages an upcoming rulemaking or announces the course which the agency intends to follow in future adjudications”) (citing Pacific Gas & Electric Co. v. FPC, 506 F.2d 33, 38 (D.C.Cir.1974); Batterton v. Marshall, 648 F.2d 694, 706 (D.C.Cir.1980) (stating that an agency action was not a general policy statement because it left “no room for further exercise of administrative discretion”). Therefore, unless the Court finds that USDA’s decision to consider E. Coli an adulterant is an “interpretive rule,” the agency violated the notice-and-comment requirements of the APA.

In describing the distinction between “interpretive rules” and rules requiring notice-and-comment (“substantive rules”), courts have stated that “`substantive rules … are those which create law, usually implementary to an existing law; whereas interpretative rules are statements as to what the administrative officer thinks the statute or regulation means.'” Brown, 607 F.2d at 700 (quoting Gibson Wine Co. v. Snyder, 194 F.2d 329, 331 (D.C.Cir.1952)). The District of Columbia Circuit presented the best reconciliation of the case law on this issue when it stated:

Accordingly, insofar as our cases can be reconciled at all, we think it almost exclusively on the bases of whether the purported interpretive rule has “legal effect”, which in turn is best ascertained by asking (1) whether in the absence of the rule there would not be an adequate legislative basis for enforcement action or other agency action to confer benefits or ensure the performance of duties, (2) whether the agency has published the rule in the Code of Federal Regulations, (3) whether the agency has explicitly invoked its general legislative authority, or (4) whether the rule effectively amends a prior legislative rule. If the answer to any of these questions is affirmative, we have a [substantive], not an interpretive rule. American Mining Congress v. Mine Safety & Health Administration, 995 F.2d 1106, 1112 (D.C.Cir.1993).

In the present case, the Court concludes that the USDA’s decision to consider E. Coli as an adulterant is an interpretive rule. The FMIA does not require the USDA to engage in substantive rulemaking as a predicate to considering a particular substance an adulterant. Young v. Community Nutrition Institute, 476 U.S. 974, 981-83, 106 S.Ct. 2360, 2364-66, 90 L.Ed.2d 959 (1986). Therefore, the “agency has the discretion to proceed through case-by-case adjudication and interpretive orders, rather than through the rule-making process.” Marsh, 715 F.2d at 909. Furthermore, the USDA has neither published the rule in the Code of Federal Regulations, nor invoked its general legislative authority. Finally, although the rule does constitute a change in USDA’s interpretation of the FMIA, it does not effectively amend a prior legislative rule.7

Based on the foregoing, the Court holds that the USDA did not violate the APA. Under the factors enumerated in American Mining Congress, USDA’s decision to consider E. Coli an adulterant is an “interpretive rule.” Furthermore, its decision to conduct sampling and testing constitutes a “procedural rule.” Therefore, the Court concludes that, as a whole, the USDA’s E. Coli sampling program is exempted from the notice-and-comment requirement of the APA.

B. Arbitrary and Capricious

In order to find that an agency action is arbitrary and capricious, the Court must find that there is no rational basis for the agency action. E.g. American Petroleum Institute v. E.P.A., 858 F.2d 261, 264 (5th Cir.1988) (emphasis added). The agency’s decision is entitled to a presumption of regularity and a Court is not empowered to substitute its judgment for that of the agency. Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 415-16, 91 S.Ct. 814, 823-24, 28 L.Ed.2d 136 (1971). However, the presumption “is not to shield [the agency’s] action from a thorough, probing, in-depth review.” Id.

Plaintiffs in this case claim that USDA’s action is arbitrary and capricious because it will not achieve its intended purpose. Among other reasons, they allege that testing is prohibitively expensive and that the industry is already doing all it can to control the problem. They also argue that USDA has singled out a particular product (raw ground beef) and a particular pathogen (E. Coli) with no adequate explanation. They allege that other pathogens currently pose greater health risks. Finally, Plaintiffs contends that USDA’s action is arbitrary and capricious because it abandons long-standing USDA policy without adequate explanation.

In response, Defendants argue that their program has already begun to achieve its intended purpose of spurring industry to use preventive measures. They also present evidence of emerging scientific and public health data, which they claim, justifies their focus on E. Coli in raw ground beef. Finally, they argue that their change in policy is due to the emerging nature of the evidence in this area.

After reviewing the evidence and arguments presented by the Parties, the Court finds that the Defendants E. Coli sampling program was not arbitrary and capricious. There is certainly a rational basis for the USDA to conduct some sort of testing in order to educate itself about this problem. Furthermore, the evidence indicates that the program has been at least partially successful in spurring industry to take greater preventive measures. Moreover, in light of the common cooking practices of most Americans, there is at least a rational basis for treating E. Coli differently than other pathogens. Finally, the Court finds that the Defendants’ changing policy is a rational response to an emerging problem.

C. Statutory Authority Under the FMIA

The Plaintiffs final claim is that USDA’s sampling program exceeds its statutory authority. The “`interpretation given [a] statute by the officers or agency charged with its administration’ is entitled to substantial deference.” Marsh, 715 F.2d at 919 (citations omitted). “Regardless of whether the court would have arrived at the same interpretation, if the agency’s interpretation is reasonable the court must respect it.” Id.

Here, the Plaintiffs do not dispute the Defendants’ general authority to test raw ground beef for E. Coli, rather Plaintiffs contest the Defendants’ decision to consider E. Coli as an “adulterant” under the FMIA. Plaintiffs’ primary argument in this regard is that E. Coli contaminated ground beef is not adulterated because it is only injurious to health if improperly cooked. However, after reviewing the evidence submitted by the Parties, the Court disagrees.

Under the FMIA, a product is “adulterated” 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 article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health….” 21 U.S.C. § 601(m)(1) (emphasis added). In construing this language, Courts have held that other pathogens, such as Salmonella, are not adulterants. See, e.g., American Public Health Assoc. v. Butz, 511 F.2d 331, 334 (5th Cir. 1975). In reaching this conclusion, the court in Butz relied upon the fact that ordinary methods of cooking and preparing food kill the Salmonella pathogen. See Id. (stating that “American housewives and cooks normally are not ignorant or stupid and their methods of preparing and cooking of food do not ordinarily result in salmonellosis”). However, unlike other pathogens, it is not “proper” cooking but “thorough” cooking that is necessary to protect consumers from E. Coli. The evidence submitted by Defendants indicates that many Americans consider ground beef to be properly cooked rare, medium rare, or medium. The evidence also indicated that E. Coli contaminated ground beef cooked in such a manner might cause serious physical problems, including death. Therefore, E. Coli is a substance that renders “injurious to health” what many Americans believe to be properly cooked ground beef. Based on this evidence, the Court finds that E. Coli fits the definition of an adulterant under the FMIA.

III. CONCLUSION

Pursuant to the foregoing analysis, the Court finds that Plaintiffs do not have a substantial likelihood of success on merits. Therefore, the Court is of the opinion that Plaintiffs’ motion should be denied.8

ACCORDINGLY IT IS ORDERED that Plaintiffs’ Motion for Preliminary Injunction is hereby DENIED.

Three petting zoo E. coli outbreaks – one in the UK.

Longview Daily News reports that two more young children have fallen ill with E. coli after visiting a Longview pumpkin patch and petting zoo earlier this month, for a total of four cases, the Cowlitz County Health Department announced Monday.

All the children visited Willow Grove Gardens in Washington between Oct. 10 and Oct. 20 and got sick with the bacterial infection between Oct. 14 and Oct. 22, said Hilary Gillette-Walch, the health department’s clinical services manager. Willow Grove Gardens is a certified organic farm operated by Michael and Ruth McKee at 8561 Willow Grove Road. The couple’s crops include pumpkins, peppers, cucumbers, melons, green beans and winter squash.

The health department issued an advisory Friday after laboratory tests confirmed one of the first two cases. All four cases involve children under age 10, Gillette-Walch said.

And then there is North Carolina – The Division of Public Health of the N.C. Department of Health and Human Services in collaboration with Local Health Departments is investigating an outbreak of E. coli infection in 106 people who attended the Cleveland County Fair. Preliminary findings suggest animal exposure may be the source of this outbreak.  As of 1 p.m., 65 children* and 41 adults are known to be/have been affected by this outbreak. Thirteen individuals* have been or are currently hospitalized.

The county case counts are as follows: Cleveland County – 61, Gaston County – 15*, Lincoln County – 14, Catawba County – 2, Union County – 2, Rutherford – 7, York County, South Carolina – 2, Cherokee County, South Carolina – 3. *this number includes one death related to the outbreak.

Here we go again!

Last Friday the Division of Public Health of the N.C. Department of Health and Human Services in collaboration with Local Health Departments is investigating an outbreak of E. coli infection in 101 people who attended the Cleveland County Fair. Preliminary findings suggest animal exposure may be the source of this outbreak.  As of 1 p.m. Friday, 62 children and 39 adults are known to be/have been affected by this outbreak. Thirteen individuals have been or are currently hospitalized. One child died.

Now Cowlitz County Health and Human Services is investigating one confirmed case and one probable case (laboratory confirmation pending) of illness caused by E. coli O157:H7 bacteria in children that visited the Willow Grove Gardens Pumpkin Patch and petting zoo. The two children became ill after visiting the farm earlier this month. One of the children was hospitalized for several days but is now recovering.

As I have said before – is it time to ban petting zoos?

I can hear the wailing and gnashing of teeth over such an un-American suggestion. Continue Reading E. coli and Petting Zoos Don’t Mix

I had a long talk today with a great barrister from Belfast Northern Ireland who asked that I send him a copy of the book Poisoned.

There are now 130 confirmed cases of E. coli in Northern Ireland’s worst ever outbreak, the Public Health Agency has confirmed.

There are a further 163 probable cases linked to Flicks restaurant in Belfast’s Cityside shopping complex.

Perhaps more people should read Poisoned – especially people that run restaurants.

So, for any first time subscribers to Marler Blog, sign up for a free subscription and email ldale@marlerclark.com that you did and she will send you a book – the first 100 anyway.

The CDC reports that a total of 22 persons infected with the outbreak-associated strain of Listeria monocytogenes have been reported from 13 states and the District of Columbia. The number of ill persons identified in each state is as follows: California (3), Colorado (1), District of Columbia (1), Maryland (3), Massachusetts (1), Minnesota (1), Nebraska (1), New Jersey (3), New Mexico (1), New York (1), Ohio (1), Pennsylvania (2), Virginia (2), and Washington (1).  20 ill persons reported being hospitalized. Four deaths have been reported. Listeriosis contributed to at least 2 of these deaths. One fetal loss has also been reported.

Collaborative investigation efforts of local, state, and federal public health and regulatory agencies indicate that imported ricotta salata cheese is the likely source of this outbreak.  On September 14, 2012, Forever Cheese, Inc. issued an expanded recall of all lots and production codes of Frescolina Marte brand ricotta salata cheese and issued a market withdrawal of all cheeses they received that were produced by the Italian cheese exporter.  Frescolina Marte brand ricotta salata cheese may also have been referred to as Ricotta Frescolina Marte Tipo Toscanella or Ricotta Salata Soft (lot number T9425) during distribution.

We have filed a wrongful death lawsuit on behalf of a child who died and a personal injury action on behalf of a woman who was hospitalized.

As Salmonella infections linked to turtles continue to be reported across the United States, Petco™ has responded with their “turtle relinquishment program” in joint partnership with Concordia Turtle Farm. The Center for Disease Control (CDC) is encouraging anyone who has an aquatic turtle under the federally mandated four-inch carapace length to relinquish them in hopes of preventing further spread of the disease. However, Petco stores will accept any aquatic turtle, regardless of size.

Since 1975, the U.S. Food and Drug Administration has banned the sale and distribution of small turtles with shells measuring less than four-inches in length. This is a necessary safety precaution that Petco has happily adhered to in order to protect the safety and wellbeing of customers. Turtles relinquished to a Petco store whose carapace length is under four inches will be shipped to Concordia Turtle Farm. The Turtle Relinquishment Program excludes stores in Hawaii.

The following safety tips from the CDC and Petco will help eliminate the potential of salmonella infection:

Don’t buy small turtles under four inches from street vendors, websites, pet stores or any other sources.

Do not capture turtles in the wild and keep them as pets.

Do not keep reptiles in child care centers, nursery schools or other facilities with young children.

Always wash hands thoroughly with soap and warm water immediately after touching reptiles or anything in the area where they live and roam. Adults should always supervise hand washing for young children. If soap and water are not readily available, use hand sanitizer.

Well, I woke up to snow this morning while parts of the world had either Salmonella or E. coli.

Dutch food safety officials have announced and increase of 76 patients with Salmonella Thompson infection. There is now a total of 1,026 people sickened by Foppen smoked. The US CDC has reported nearly 100 Salmonella Thompson case in the US, but have not linked them to smoked salmon consumption.

The Division of Public Health of the N.C. Department of Health and Human Services in collaboration with Local Health Departments is investigating an outbreak of E. coli infection in 104 people who attended the Cleveland County Fair. Preliminary findings suggest animal exposure may be the source of this outbreak.  As of 1 p.m., 63 children* and 41 adults are known to be/have been affected by this outbreak. Thirteen individuals* have been or are currently hospitalized. The county case counts are as follows:

Cleveland County – 61

Gaston County – 14*

Lincoln County – 14

Catawba County – 2

Union County – 2

Rutherford – 6

York County, South Carolina – 2

Cherokee County, South Carolina – 3

*this number includes one death related to the outbreak

The Belfast Public Health Agency (PHA) confirmed that 124 cases have been confirmed and a further 166 are suspected to be part of the outbreak linked to Flicks, a sit-down eatery in Belfast.

The Public Health Agency (PHA) and Environmental Health Officers from Belfast City Council are continuing to investigate an outbreak of Escherichia coli (E. coli) O157 linked to Flicks restaurant in Cityside Mall, 100-150 York Street, Belfast. As of 3pm on Wednesday 24 October 2012, there were 124 confirmed cases and 166 probable cases. The increase in confirmed cases over recent days is not unexpected and is as a result of probable cases becoming confirmed following testing. The number of probable cases is leveling off as fewer new reports are coming forward.

 

A total of 38 persons infected with the outbreak strain of Salmonella Bredeney have been reported from 20 states. The number of ill persons identified in each state is as follows: Arizona (1), California (7), Connecticut (3), Illinois (1), Louisiana (1), Massachusetts (3), Maryland (1), Michigan (1), Minnesota (1), Missouri (2), Nevada (1), New Jersey (2), New Mexico (1), New York (1), North Carolina (1), Pennsylvania (2), Rhode Island (1), Texas (5), Virginia (1), and Washington (2).

Collaborative investigation efforts of state, local, and federal public health and regulatory agencies indicate that Trader Joe’s Valencia Creamy Salted Peanut Butter made with Sea Salt, manufactured by Sunland, Inc. of Portales, New Mexico, is a likely source of this outbreak.