New Initiatives for Import Safety
by Marian Segal

George Richards knew something was amiss when he went back to the M & T       
Warehouse in San Francisco to check on some mushrooms.

Three months before, Richards, an inspector with FDA's San Francisco          
district, had collected a documentary sample (paperwork, photographs,         
invoices) from a lot of 343 cases of mushrooms imported from the Peoples      
Republic of China by Tak Yuen Corporation of San Francisco. (Products         
sampled must be held and kept from distribution until FDA releases them.)

This was in accord with an import alert FDA had issued instructing all        
districts to automatically detain mushrooms from China because several        
outbreaks of food poisoning had been associated with them. Richards had       
noted the numbers on the mushroom cases, marked his initials on three of      
them, sealed them, and prepared a documentary report for the sample.

When he came back to the warehouse on assignment to collect physical samples  
from the same lot of mushrooms, Richards discovered that the mushrooms he     
had originally looked at were gone. The only mushrooms in the warehouse had   
numbers different from the original cases and were not marked with his        
initials.

Further investigation showed that Tak Yuen had sold the mushrooms and         
substituted for them identical mushrooms it had imported through Seattle.     
FDA referred the case to the Department of Justice, which successfully        
prosecuted the corporation and its import manager and president.

FDA is cracking down on importers like Tak Yuen that flagrantly violate U.S.  
import laws. It is part of a new agency initiative to enhance protection of   
consumers from imports that don't meet U.S. standards. It targets problem     
importers who, according to FDA Commissioner David Kessler, M.D., "seem to    
specialize in bringing in goods that violate FDA standards and regulations."  
Kessler stresses that FDA's strategy to step up enforcement actions against   
these "willful violators" will not complicate the business of importers       
whose operations are aboveboard and whose products meet U.S. standards.

The focus, he says, is on "professional lawbreakers and rogues who count on   
the hectic pace of international trade to get away with substandard goods     
and excessive profits, regardless of the potential consequences to American   
public health."

Foods have always been high on the list of violative imports, accounting for  
77 percent of imported goods turned back in 1991. This may not be             
surprising, considering that foods constitute 75 percent of the volume of     
imports under FDA's purview. Another 14 percent are medical devices, 7        
percent are human and animal drugs, and the rest are biologics and cosmetics.

By law, all FDA-regulated imports must meet the same standards as domestic    
goods. Foods must be pure, wholesome, safe to eat, and produced under         
sanitary conditions; drugs and devices must be safe and effective; cosmetics  
must be safe and made from approved ingredients; and all labeling and         
packaging must be informative and truthful.

A Booming Business

The volume of FDA-regulated imports has tripled in the last two decades from  
about a half million shipments in 1971 to one and a half million today.       
During any given week, the United States may import coffee from Kenya, fresh  
vegetables from Mexico, shrimp from India, perfume from France, drugs from    
Denmark, surgical instruments from Germany, cosmetics from Taiwan, and        
suntan beds from Sweden. In another 10 years, the number of FDA-regulated     
imports is expected to reach two and a half million.

To meet the rising demands on the agency of this burgeoning commerce, FDA     
has increased its import operations staff over the past several years and     
expanded surveillance. This boost in strength was accomplished--despite an    
overall reduction in agency resources--by shifting staff from domestic        
activities.

Surveillance

Import surveillance is not a glamorous job. It's usually carried out in       
gray, sprawling warehouses in the least fashionable part of town, or at       
remote border crossings. But it's a vital activity high on the agency's       
public health agenda.

Through its district offices and resident posts, FDA is directly or           
indirectly involved in surveillance at each of the approximately 400 U.S.     
Customs Service points of entry in the country, including major airports. At  
the many remote crossings along the Canadian and Mexican borders, FDA relies  
on the Customs Service for help in identifying suspicious products. On a      
normal workday, about 200 to 300 FDA inspectors, laboratory analysts, and     
compliance officers handle imports.

State regulatory agencies also cooperate with FDA on import surveillance.     
State inspectors examine certain products once they're on the U.S. market     
and share information with other state officials and federal regulators. The  
Association of Food and Drug Officials, an organization of federal and state  
officials, is setting up a committee to explore how FDA and its state         
counterparts can work together to regulate imports more effectively.

Inspections

Inspecting and sampling imported goods is at the heart of import operations.  
Inspections have become more complex and time-consuming, not only because     
the volume of imports is increasing, but also because the nature of the       
products is changing.

Mary Ayling, acting director of FDA's import policy and enforcement branch,   
began her career with the agency as an inspector in Oregon. "When I first     
started in 1972," Ayling says, "most of what we looked at was bulk            
products--big bags of coffee or rice stuffed in the hold of a ship--on its    
way to a firm for repacking or processing. In those days you might inspect    
one or two bulk shipments, looking for chemical contamination among the       
burlap bags or rodent droppings in the hold. It was like the journey of       
Fieval in 'An American Tail.' They'd bring the whole family and make a        
little nest."

By the mid-1970s, more finished products were appearing, packed in 30-foot    
containers. "Instead of just seeing big bags of rice, you started seeing      
rice products--rice paper, rice flour--ready to be sold directly to the       
consumer," Ayling explained. "It was like a grocery store in a                
container--40, 50, 100 different products in a container."

The new kinds of products made it necessary to conduct a different kind of    
inspection, looking for different signs of problems.

"For instance," Ayling says, "there's a big influx now of canned foods and    
products in hermetically sealed pouches. There are incredible health hazards  
involved with improperly processed canned foods. Low-acid canned foods, such  
as asparagus, green beans, peppers, and mushrooms, are potential sources of   
botulism food poisoning."

With these kinds of products, the inspectors check to see if the              
manufacturer and the manufacturing process are registered with FDA, as        
required; make sure the labels are printed in English and conform with other  
FDA requirements about weight declaration, contents, and so forth; and        
spot-check for swollen, leaking or rusty cans, wet cases, or swarms of        
insects around cases, which may indicate damaged cans.

Seafood is inspected for signs of parasites and for evidence of thawing and   
decomposition.

When examining medical and radiation-emitting devices, inspectors check to    
see that the importer is registered and the device is listed with FDA and     
pre-market notification has been submitted. They look for labeling            
declarations or certifications, and examine the packing to make sure          
sterility seals are intact.

"There's a big increase in imported devices," Ayling says. "In connection     
with AIDS, the foreign device industry in condoms and surgical gloves has     
exploded." She says that devices are getting more "interesting" as well,      
mentioning a recent shipment of boxer shorts. "Of course we don't normally    
regulate boxer shorts," she says, " but the Customs inspector, noticing that  
the shorts had little pockets, each with a condom in it, correctly decided    
that this was an item for FDA."

Drug Shipments

Drug shipments present a special challenge to agency inspectors. Drugs        
entering the United States must comply with FDA laws and regulations. They    
must be listed with FDA, properly labeled, and not make any false or          
misleading claims. Inspectors check labels and look for tamper-resistant      
packaging and signs of possible contamination, such as cracked vials and      
broken bottles. As with other imports, potential problem drugs are targeted   
in advance for sampling and detention.

FDA lets its field offices use their discretion in allowing entry of small    
"personal use" quantities (generally not more than a three-month supply) of   
foreign drugs not approved in the United States. For an unapproved drug to    
be entered into the United States for personal use, it must meet certain      
criteria, including the following:
 -It must pose no unreasonable safety risk. (Products from unknown sources    
are considered to pose a safety risk.)
 -Satisfactory approved treatment for the condition must not be available in  
this country.
 -It must not be promoted for sale in this country.

Although it is impossible to physically inspect each item coming into the     
country, FDA does review records for all shipments of goods it regulates.     
From this review, the inspector may decide to release the product for         
distribution or mark it for further scrutiny. Ten percent of the entry        
records reviewed are marked for a closer look either by physical examination  
or sampling and laboratory analysis.

Surveillance 'Blitzes'

One way to quickly gather information on a suspected problem is to conduct    
what inspectors call a "blitz," a short-term intense surveillance of a        
product at all or selected ports of entry. FDA is making use of this          
strategy in its heightened focus on imports. Recently, the agency             
concentrated on food-use ceramic ware, looking for excessive lead levels.     
From Jan. 31 to Feb. 21, 1992, FDA inspectors in every port in the country    
examined ceramic foodware products ranging from fine bone china to Mexican    
pottery.

Assisted in many instances by state authorities, FDA inspectors examined      
5,270 lots of ceramic ware. The results were encouraging. They found only 59  
violative lots, 31 of which did not meet new, lowered levels for permissible  
lead content that had been in effect only a couple of months.

Handling Problems

Under routine surveillance, if inspectors find or suspect a problem, they     
can hold the shipment and collect a sample for analysis. About 3 percent of   
all entries are sampled this way. In 1991, FDA detained 27,298 shipments--62  
percent more than in 1985.

In the first quarter of fiscal year 1992, FDA detained more than 13,000       
violative shipments. Many were dietary weight-loss products promoted through  
the mail, such as diet pills from Mexico and starch blockers.

When a product appears to be adulterated or misbranded under the federal      
Food, Drug, and Cosmetic Act, the importer is given an opportunity to bring   
it into compliance through reconditioning or relabeling. For example, to      
recondition insect-infested rice, the importer could fumigate and process     
it, using FDA-approved methods, to eliminate the insects. Relabeling might    
be sufficient for a food that contains sulfite preservatives not identified   
on the label. (Sulfites must be listed on the label because some people are   
sensitive to them and could have life-threatening reactions.)

Certain imports that violate FDA regulations cannot be reconditioned and      
must be exported or destroyed by the importer. This includes products that    
appear to have been manufactured, processed or packed under insanitary        
conditions, devices that have not been produced in accord with good           
manufacturing practices, and products that are prohibited in the country of   
manufacture, such as perfumes containing chlorofluorocarbons (CFCs). (A       
group of chemicals used widely in a variety of products, CFCs have the        
potential to destroy the earth's protective atmospheric ozone layer.)

International Cooperation

To further expedite surveillance, FDA has entered into agreements with        
foreign governments. Through memorandums of understanding (MOUs),             
governments agree to make sure their products are manufactured under          
sanitary conditions, meet U.S. standards for quality, and are tested and      
sampled correctly before leaving the country. For example, to help ensure     
that shellfish are grown, processed, packaged, and shipped properly, FDA has  
nine MOUs with countries that export shellfish to the United States.

"If a foreign firm is listed in a new drug application as a supplier of an    
ingredient for the drug, FDA inspects the plant to make sure it meets the     
agency's good manufacturing practices. If the firm refuses to be inspected,   
FDA will not permit it to be a supplier," says Paul Motise, consumer safety   
officer in FDA's policy and guidance branch. "Also, firms that plan to bring  
finished drug products into this country are inspected for GMPs," he says.

Sometimes FDA inspects foreign plants at the invitation of the host country.  
An invitation may come because the manufacturer wants to sell its product in  
the United States. Other times, an invitation may come after products have    
been detained, because the manufacturer wants advice on meeting FDA           
standards. Products from 10 foreign drug manufacturers and 36 foreign         
medical device manufacturers are currently automatically detained as a        
result of findings from foreign inspections.

Computer Support

To meet the increasing demands on FDA for surveillance and streamlined        
operations, the agency is working to automate its import operations. It is    
developing a sophisticated computerized import support and information        
system with the acronym ISIS, which will provide product and arrival data     
more quickly.

"This will enable the agency to better track import trends and allocate its   
resources where they are most needed," says Ayling. "It will also help to     
quickly identify and alert the districts to possible problems and to build    
national historical data files that can be worked into profiles on specific   
products, shippers and importers."

Agency officials hope the system will also help them discover and clamp down  
on importers engaging in the unscrupulous practice of "port shopping," in     
which a shipper or importer tries to sneak adulterated and misbranded food    
or other products through the import screening process.

"When they get caught in one port, they brazenly take the same shipment to    
another U.S. port and try again and again," says Kessler, "and we're          
determined to put a stop to it."

FDA's closest partner in import surveillance is the U.S. Customs Service,     
which provides the agency with substantial information about suspected        
violators. Indeed, much of the data for FDA's ISIS will come through          
Customs' automated system. The two agencies have agreed to link their         
systems so that data on FDA-related products entered into Customs' system     
will automatically be transferred to ISIS. A pilot project will begin this    
year in FDA's Seattle district.

Industry Education

The importer has primary responsibility for making sure foreign goods comply  
with U.S. regulations. FDA is stepping up its industry education programs,    
while field staff continue to meet with brokers and importers to educate      
them about their legal responsibilities and the need for vigilance in         
complying with the law. Coupled with state participation, these educational   
efforts should lead to improved product quality and less likelihood that      
importers will face enforcement action.

"The whole thrust of the initiative," says Ayling, "is to bring home to the   
importers that it is their responsibility to see to it that the goods they    
bring to this country measure up to U.S. standards. We can't use our          
resources for their quality control process." n

Marian Segal is a member of FDA's public affairs staff.

Import Alerts and Penalties

To help its inspectors cover the vast number of imports, FDA issues alerts    
to its district offices. These alerts contain the names and descriptions of   
products, shippers or importers that have repeatedly violated FDA laws or     
regulations. FDA currently has 350 alerts on products and importers.

The import alert signals FDA inspectors to pay special attention to a         
particular product when it arrives in port and, in certain cases, to          
automatically detain it. Some products FDA inspectors currently detain        
automatically are:
-ceramic ware from at least 11 countries, because of possible lead            
contamination

swordfish from all countries, because of high mercury levels

canned mushrooms from the People's Republic of China, because they have       
caused several outbreaks of staphylococcal food poisoning.

Once a product is placed on automatic detention, it will not be allowed into  
the country until the shipper or importer proves that the product             
consistently meets all FDA standards. As of October 1991, 174 different       
products and 904 shippers were on automatic detention.

Product detention is not the only penalty imposed for violating FDA           
regulations. Offenders may also have to face civil and criminal charges. FDA  
recently sent warning letters to several importers with significant records   
of violative practices. The letters say that failure to stop this conduct     
might result in "regulatory action without further notice, such as seizure,   
injunction, automatic detention of future shipments, or possible              
prosecution." 

Importers who receive such letters have 15 working days to notify FDA in      
writing of the specific steps they're taking to correct the violation and     
what they're doing to make sure it won't happen again. n

--M.S.