When the inspector comes

Blue Lake fish and sauce entrepreneurs take the FDA's tsk-tsking in stride



You can tell a happy operation when you see one. At least, that's how it seemed last Friday mid-morning inside Fish Brothers, in Blue Lake's industrial park, where hair-netted Codey Summerfield spun, a blur, with a roll of clear plastic around a fat pallet stacked with boxes of smoked fish, driven by the relentless happy-defiant beat of Flogging Molly's "Black Friday Rule."

"I want to believe in myself once again..." Around and around, he wrapped the pallet... "I'd give you my heart, if you gave me the truth..." Spinning, spinning... "This mess in my head is a mess getting out. Ya drink too much coffee, I drink too much stout."

In no time flat, the pallet was cocooned in plastic, ready to be shipped off to market, and Summerfield moved on to the next project. His boss, Scott Bradshaw, stood nearby smiling. Bradshaw started Fish Brothers in his house in Trinidad 27 years ago and by 1998 had moved into this warehouse that he co-built with Tom Pagano, whose business Tomaso's Specialty Foods and Distributing, begun in 1990 in his kitchen in Trinidad, is next door; the property line between their businesses runs down the middle of the building. And, likewise, over on Pagano's side last Friday, things seemed peaceful. Overall, they'll both tell you, things have been great -- even now, despite both companies' having been recently knuckle-rapped by the federal Food and Drug Administration for assorted violations.

Actually, Pagano's had two FDA run-ins in the past couple of years, both of which resulted in his being ordered to recall a product because of a labeling issue. There were no health incidents involving the products; both recalls followed regularly scheduled inspections. After one inspection, in August 2009, the FDA ordered Pagano to recall his Tomaso's Puttanesca pasta sauce because the ingredients label did not mention one of its ingredients, anchovies, a known allergen.

"It was a mistake in the printing," said Pagano, sitting inside Bradshaw's office Friday morning. "So, we just deleted anchovies from the recipe."

The second recall, announced Jan. 31, was for Tomaso's Caesar salad dressing, whose label failed to note the presence of eggs and milk, known allergens. The eggs are in the mayonnaise used to make the product, which is listed on the label; the FDA told Pagano he needs to spell out such complex ingredients as mayonnaise. This time, after personally collecting a half dozen cases of the product from local shelves -- Pagano distributes his and several other people's products in Humboldt County only -- Pagano fixed the problem by printing all-encompassing little sticky labels that say "Allergen alert: eggs, milk and anchovies" and slapped them on the jars.

"And that [offending] label has been the same for the last 15 years," Pagano said. "But now they're really cracking down on labeling, especially with allergens."

That wasn't the end of it. Although there've been no other recalls ordered, Pagano said the FDA has told him he has to expand the label ingredients lists on all of his products -- adding in relevant parenthetical sub-ingredients for certain main ingredients, as in the mayonnaise case. And, he must conform to its rules for noting measurements.

"And that's all fine." he said. "It's all for public safety. The only bitch I have with them is when they came in in March and pointed out stuff I needed to change on the labels. I spent thousands of dollars -- up to $10,000 -- on new labels. For instance, they said the nutrients were not labeled in both U.S. and metric measurements. So I did it, and then three months later they came back and said, ‘Your labels are all off.'"

This time, he said, the FDA didn't like that his labels listed exact measurements of nutrients, and told him to round up or round down each figure.

"That pissed me off," he said. "I called them up and said, 'Are you going to pay me to print new labels?' They said they couldn't do that. I said, ‘I'm not going to reprint new labels until the FDA signs off on them.' So I'm going to send the new, corrected label proofs to the compliance officer at the FDA."

He doubts the FDA will sign off like that; likely, he'll have to just print them again and hope no more faults are found with the labels.

Meanwhile, Bradshaw, at Fish Brothers, received a warning letter from the FDA last November after a multi-day visit from the agency in August. The FDA inspectors found "serious violations" of the Hazard Analysis and Critical Control Point (HACCP) regulations, according to the warning letter, which is posted on the FDA's website. Under those regulations, which apply to all fish and seafood processors in the United States, a company has to create a detailed plan for how it analyzes and controls biological, chemical and physical hazards at each "critical control point" of the production process. The HACCP involves extensive record-keeping, including processing temperature charts, hygiene records, receiving logs, refrigeration temperature charts, brining concentrations and times, and more. The FDA said Bradshaw's HACCP plan didn't have adequate corrective action plans for resolving the causes of deviations from the regulations.

One issue the FDA dwelled upon more specifically was Bradshaw's employees' use of sanitizers.

"On 8/10/10, an employee was observed spraying the stainless steel table used to hold smoker racks with an unknown clear liquid from an unmarked plastic spray bottle in which the employee stated contained "sanitizer," said the letter.

The liquid turned out to be an accepted sanitizer, although in too-high of a concentration. The FDA told Bradshaw the label all of the sanitizer bottles and have employees follow proper protocols for their use.

The inspector also counted five live flies in the processing, packaging and raw ingredients storage areas, including one that landed on the edge of partially opened bag of brown sugar. She counted 50 dead flies on a fly strip in the processing area. And there were spider webs "on the corner of light fixtures directly above the area where ready-to-eat smoked salmon was being packaged and in the processing area where brined and cooked salmon were being processed," the letter noted.

Bradshaw fixed most all of these problems before the warning letter came out -- the spider webs he dealt with the day of the inspection; he put up more fly strips and installed mesh screen flaps over the processing area's entryway to keep flies out; and he worked on the HACCP wording. One area in which he balked, however, was over brining times. He brines his fish for 16 hours in a refrigerator; he said the FDA rules don't distinguish between refrigerated brining and room temperature brining.

"The inspector said, ‘Brining longer than 12 hours could lead to Staphylococcus aureus,'" he said. "But  there's nothing in the literature that says that [Staph. aureus will form] if you brine at cold temperatures. And I have to brine that long for there to be enough salt, and salt is a preservative -- so I need those brine times."

So, Bradshaw and Pagano both still have some issues to work out with the FDA. And you might think they'd be put out by all this scrutiny -- you know, small businesses burdened by onerous government regulations, that kind of thing. But they're not complaining.

"It's always disconcerting when they visit, and they come unannounced," said Bradshaw. "But I don't get that nervous. And, generally, I feel pretty good about their HACCP plan. It's been 17 years since that was enacted, so there's been time to adjust. And the inspectors are always very professional and cordial, and they point out stuff that needs to be pointed out. Ultimately, I feel we should work with them so that we produce safe food for the public."

Pagano agreed. In fact, he'd like more consistent inspections, and he told the last batch of inspectors that.

"I told them they need to have an FDA officer permanently in Humboldt County," Pagano said. "There's so many food producers here. But, I know there's no budget for it." 


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