HHS Issues New Rules to Enhance Security of the US Food Supply

October 09, 2003

US Dpeartment of Health and Human Services (HHS) Secretary Tommy G. Thompson announced the issuance of two Food and Drug Administration regulations that will bolster the safety and security of America's food supply. The new regulations will enable better targeted efforts to monitor and inspect imported foods and will allow quick identification and notification of food processors and other establishments involved in any deliberate or accidental contamination of food.

"By requiring advance notice for imported food shipments and registering domestic and foreign food facilities, we are providing critical new tools for the FDA to identify potentially dangerous foods and better keep our food supply safe and secure," Secretary Thompson said. "These new requirements represent the latest steps in our ongoing efforts to respond to new threats and improve the safety of all the foods that we eat in this country."

The two new regulations will implement key provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which provided FDA new authority to protect the nation's food supply against actual or threatened terrorist acts and other food-related emergencies.

The first regulation requires food importers to provide the FDA with advance notice of human and animal food shipments imported or offered for import on or after Dec. 12, 2003. This will allow FDA to know, in advance, when specific food shipments will be arriving at U.S. ports of entry and what those shipments will contain. This advance information will allow the FDA, working with U.S. Customs and Border Protection (CBP), to more effectively target inspections and ensure the safety of imported foods. The FDA expects to receive about 25,000 notifications about incoming shipments each day.

The second regulation requires domestic and foreign food facilities that manufacture, process, pack or hold food for human or animal consumption in the United States to register with the agency by Dec. 12, 2003. As a result, FDA will have for the first time a complete roster of foreign and domestic food facilities. The requirements will enable the FDA to quickly identify and locate affected food processors and other establishments in the event of deliberate or accidental contamination of food. The FDA expects about 420,000 facilities to register under this requirement.

The FDA worked closely with CBP to ensure the new regulations promote a coordinated strategy for border protection.

The regulations reflect comments from a broad array of law enforcement, national security, industry and other experts as the FDA worked to effectively improve food safety and security without adding unnecessary costs to domestic or international trade.

Under the prior notice regulation, prior notice of imported foods must be received and confirmed electronically by FDA no more than five days before its arrival and no fewer than:

  • two hours before arrival by land via road;
  • four hours before arrival by air or by land via rail; or
  • eight hours before arrival by water.

In addition, for international mail shipments, notifications must be made before the shipment is mailed. Also, when an individual carries or otherwise transports foods subject to the new requirement, advance notice of two, four or eight hours is required -- depending on the mode of transportation. The food must also be accompanied by confirmation of receipt for FDA review.

The regulation's timeframes reflect the FDA's work, in collaboration with other agencies, to reduce substantially the required time for advance notice to minimize unnecessary costs. For example, the proposed rule issued earlier this year would have required that importers give notice by noon the day before the arrival of a shipment of food into the United States for all modes of transportation, including by land by road. The final regulation requires only two hours notice before arrival of food by land by road and could be reduced further in the future as part of FDA-CBP plan to coordinate border-management activities more efficiently.

The advance notice to the FDA may be submitted electronically in most circumstances using Customs' existing ABI/ACS system, making it easier for importers to comply with the new law. In addition, the FDA will operate a new Prior Notice System Interface that can receive such notifications.

The second regulation requires the owner, operator, or agent in charge of a domestic or foreign food facility to register with FDA, providing information about the name and address of each facility at which, and all trade names under which, the registrant conducts business, and information about certain categories of food the facility produces. For a foreign facility, the registration must include the name of the U.S. agent for the facility.

Registration is required for domestic facilities whether or not food from the facility enters interstate commerce. Domestic facilities are also required to provide emergency contact information. All changes to such information must be reported within 60 days.

Except for specific exemptions, the registration requirements apply to all facilities that manufacture, process, pack or hold food regulated by FDA, including animal feed, dietary supplements, infant formula, beverages (including alcoholic beverages) and food additives.

Registration would not be required for private residences of individuals; certain food transport vehicles; facilities that manufacture food contact substances and pesticides; farms; restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer; non-processing fishing vessels; and facilities (such as meat and poultry slaughterhouses) that are regulated exclusively by the U.S. Department of Agriculture. Also exempt are foreign facilities if the food from the facility is to undergo further processing or packaging by another facility before it is exported to the U.S.

The registration may be submitted electronically, via the Internet, or by paper through surface mail or by fax. Registrations may also be submitted on CD-ROM by mail. The FDA will be able to accept electronic registration from anywhere in the world 24 hours a day, 7 days a week, beginning Oct. 16. Filling out registration online should take about 15 minutes if a facility has its paperwork ready. A registering facility will receive confirmation of electronic registration and its registration number instantaneously once all the required fields on the registration screen are filled in. There is no fee associated with registration.

The rules take effect Dec. 12, 2003, in accordance with the Bioterrorism Act. To assure that the regulations can be implemented efficiently and with minimal disruption, FDA intends to exercise broad enforcement discretion for the prior notice rule for the first four months after implementation. During this time, FDA and CBP will educate importers about how they can comply with the regulations, and will work with trade associations and foreign governments to make sure all importers are well informed of the new requirements. Thereafter, FDA will phase in full implementation of the prior notice requirements.

FDA has already conducted extensive domestic and international outreach and education about the new rules. In the coming weeks, FDA will conduct national and international meetings and other programs to provide full information about the rules. FDA also will hold a satellite downlink public meeting on Oct. 28 to discuss the two regulations. 

Both the new regulations were published as interim final rules in the Oct. 10 issue of the Federal Register. The FDA is requesting further public comment on the rules. 

Fatal Accident at Ohio Steel Firm Brings $288,250 in Fines

OSHA announced that it has fined Progressive Processing, Inc., of Elyria, Ohio, $288,250 for failing to protect workers from a variety of safety and health hazards.

OSHA opened an inspection at Progressive Processing on April 9 following a fatality in which an employee's clothing became entangled in the rotating parts of machinery. OSHA's investigation not only found willful violations of machine guarding regulatory standards, but also determined that the steel processing firm failed to protect against employee hearing loss and was failing to properly record work-related injuries and illnesses that could have initiated an OSHA inspection. The federal workplace safety agency also found willful safety violations with the operation and maintenance of industrial trucks among, other workplace safety issues.

"Machinery accidents are a major cause of job-related injuries and fatalities across the country. These accidents are preventable. Measures can and must be taken by employers to prevent such accidents. The penalty amount of $288,250 is an indication of the seriousness of this matter," said U.S. Secretary of Labor Elaine L. Chao.

OSHA has conducted four previous inspections since 1985 at Progressive Processing resulting in eight serious violations issued. The business employs approximately 150 workers in the processing of round steel bar stock primarily for the automotive industry.

The company has 15 working days from receipt of the citations to appeal before the independent Occupational Safety and Health Review Commission.

Network of Employers for Traffic Safety Aligns with OSHA to Reduce Job-Related Traffic Injuries and Fatalities

Reducing work-related traffic injuries and deaths is the goal of a new Alliance OSHA has formed with the Network of Employers for Traffic Safety (NETS).

"Motor vehicle incidents are one of the top causes of fatalities on the job," said OSHA Administrator John Henshaw. "Our Alliance with NETS will strengthen our outreach efforts to increase awareness about roadway safety and enable us to achieve a greater impact by saving lives and preventing traffic related incidents at worksites all across the country."

"Safe driving is everyone's business and employers must do their part to make safe driving practices a part of every trip, every day," said Kathryn Lusby-Treber, Executive Director of NETS. "We believe that our new cooperative relationship with OSHA will advance a culture of prevention that will reduce traffic collisions and related deaths and injuries in our nation's workforce."

OSHA and NETS will work together to provide employers of all sizes with access to information and resources such as OSHA's Compliance Assistance Specialists and NETS States that can be used to create effective workplace traffic safety programs, develop and disseminate materials that promote safe driving practices, and work on electronic assistance tools for workplace traffic safety programs, including fleet safety programs.

The Alliance calls for OSHA and NETS to promote a national dialogue on workplace safety and health that will raise awareness of safe driving practices and traffic safety programs. The members will convene or participate in forums and round table discussions on safe driving practices to help forge innovative solutions to traffic safety issues in the workplace and work with other Alliance participants on specific issues and projects related to traffic and fleet safety.

A joint team of representatives from OSHA and NETS will meet regularly to develop an action plan, determine working procedures, and identify the roles and responsibilities of the participants. In addition, they will meet at least quarterly to track and share information on activities and results in achieving the goals of the Alliance.

Created in 1989 by public and private sector leaders, NETS develops safety policies, workplace informational and training programs and corporate community activities to help reduce traffic-related deaths and injuries.

OSHA Small Business Outreach Seminars on Lockout/Tagout To Be Offered In November

Helping small Upstate New York employers protect their workers against the unexpected startup of equipment and controlling hazardous energy sources are the goals of seminars being offered by the Buffalo office of OSHA in conjunction with area organizations and colleges.

The same seminar, on the topic of lockout/tagout, is being offered at six different locations during November as follows:

November 6, 2003 9:00 - 11:00 a.m. Erie Community College South Campus, Orchard Park, NY
  1:00 - 3:00 p.m. NCCC Corporate Training Center, Lockport, NY
November 13, 2003 9:00 - 11:00 a.m. Jamestown Community College, Jamestown, NY*
  1:00 - 3:00 p.m. Jamestown Community College, Olean, NY*
November 20, 2003 9:00 - 11:00 a.m. Genesee Community College, Batavia, NY
  1:00 - 3:00 p.m. SUNY Brockport MetroCenter, Rochester, NY*

"The unexpected startup of machinery or other powered equipment can be extremely dangerous. Failing to isolate and lock out all energy sources when servicing or maintaining equipment can lead to severe injury and even death." said Art Dube, OSHA's Buffalo area director. "Employers and workers need to know how to properly identify what energy sources may be present in their workplace and how to isolate and lock out each source. This seminar will show small business owners how they can effectively assess and address this workplace hazard."

The session is part of the OSHA Small Business Seminar Series covering a variety of topics that the federal agency will offer this year to assist small Upstate New York employers in complying with workplace safety and health standards.

To register for one of the November seminars, or to obtain more information, contact Gordon DeLeys at the Buffalo OSHA Area Office at 716-684-3891 extension 244.

* A $10 fee will be charged at the Jamestown, Olean and Rochester locations.