Register a US agent under the Bioterrorism Act

PUBLIC HEALTH SECURITY
AND BIOTERRORISM PREPAREDNESS
AND RESPONSE ACT OF 2002
(Public Law 107-188)

Public Law 107-188
• Signed into law on June 12, 2002 by President Bush
• Represents the most significant amendments to FDA’s food statute in decades.

Public Law 107-188

Title I: National Preparedness for Bioterrrorism and Other Public Health Emergencies

Title II: Enhancing Controls on Dangerous Biological Agents and Toxins

Title III: Protecting Safety and Security of Food and Drug Supply

Title IV: Drinking Water Security and Safety

Title V: Additional Provisions (including PDUFA)

TITLE I : NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH EMERGENCIES

Directs the Secretary to further develop and implement a coordinated preparedness plan. This includes establishing new positions, creating working groups, and providing for education and training. The provisions also establish grants for States to improve emergency preparedness infrastructure and programs.

TITLE II : ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS

Provides for more stringent controls of biological agents and toxins. This includes establishing new criteria for the registration of select agents; criteria for security of labs handling select agents; and coordinating with USDA to ensure similar regulation of select agents under USDA’s jurisdiction.

TITLE III: PROTECTING SAFETY AND SECURITY OF FOOD AND DRUG SUPPLY

Enhances FDA’s ability to protect the food and drug supply:

Subtitle A - Protection of Food Supply
Subtitle B - Protection of Drug Supply

Subtitle A - Protection of Food Supply

Sec. 301: Food Safety & Security Strategy

Sec. 302: Protection Against Adulteration of Food

Sec. 303: Administrative Detention

Sec. 304: Debarment for Repeated or Serious Food Import Violations

Sec. 305: Registration of Food/Feed Facilities

Sec. 306: Maintenance and Inspection of Records for Food

Sec. 307: Prior Notice of Imported Food Shipments

Sec. 308: Authority to Mark Articles Refused Admission into the United States

Sec. 309: Prohibition Against Port Shopping

Sec. 310: Notices to States Regarding Imported Foods

Sec. 311: Grants to States for Inspections

Sec. 312: Surveillance and Information Grants and Authorities

Sec. 313: Surveillance of Zoonotic Diseases

Sec. 314: Authority to Commission Other Federal Offices to Conduct Inspections

Sec. 315: Rule of Construction

Sec. 301: Food Safety and Security Strategy

Requires the President’s Council on Food Safety to develop a crisis communications and education strategy regarding bioterrorist threats to the food supply.

Sec. 302: Protection Against

Adulteration of Food Directs the Secretary to give high priority to increasing activities related to imported food safety. This includes increasing imported food inspections, improving information management systems, and continuing to develop rapid testing and sampling methods.

Sec. 303: Administrative Detention

An officer or qualified employee of FDA may order detention of food if there is credible evidence or information that the food presents threat of serious adverse health consequences or death to humans or animals Detention may not exceed 20 days, unless a longer period (not to exceed a total of 30 days) is necessary to pursue seizure or injunction

Requires FDA to develop regulations to provide for an expedited detention process for perishable foods Detention order may require marking or labeling the food as detained (different from Sec. 308 marking)

Detention order shall require removal to a secure facility, as appropriate

Detention may be appealed

– within 5 days from date appeal is filed, and an opportunity for an informal hearing has been provided, a decision must be made to either confirm or terminate the detention order
– confirmation of the detention order subject to judicial review;
– appeal process terminates if seizure or injunction filed;
– detention order terminates if 5-day appeal requirements not met

Transferring an article of food in violation of detention order or removing or altering any required mark or label is a prohibited act

Provides for temporary holds at ports of entry

Requests U.S. Customs Service to hold food at port of entry for 24 hours when credible evidence or information that an article of food presents a threat of serious adverse health consequences or death to humans or animals and the officer needs more time to inspect, examine, or investigate

Removal to secure facility as appropriate

Notification of the request to hold provided to the port-of-entry State
Sec. 304: Debarment for Repeated or Serious Food Import Violations
Allows FDA to debar importers with a history of FDA-related food import violations from continuing to do business with the United States

Sec. 304: Debarment for Repeated or Serious Food Import Violations

Authorizes FDA to debar:
– persons convicted of a felony related to food importation; or,
– persons who engaged in a pattern of importing or offering for import adulterated food that presents a threat of serious adverse health consequences or death to humans or animals

Importing or offering for import food by, with the assistance of, or at the direction of a debarred person is a prohibited act.

Food offered for import by a debarred person will be held at the port of entry, at a secure facility as appropriate, unless it is transferred to a non-debarred person who can ensure the article complies with Act.

Sec. 305: Registration of Food Facilities

Provides for the mandatory, one-time, registration with FDA of domestic and foreign food and animal feed facilities – through regulations FDA will develop

• Includes any factory, warehouse, or establishment that manufactures, processes, packs, or holds food

• Exempts farms, restaurants, other retail food establishments, nonprofit food establishments in which food is prepared or served directly to the consumer, and fishing vessels that do not process

• Applies only to foreign facilities whose products are exported to the U.S. without further processing or packaging outside the U.S.

• Owner, operator, or agent in charge shall submit the registration

• Registration must include:

– Name and address of each facility;
– All trade names under which the facility is doing business;
– Foreign facilities must provide name of United States agent;
– When determined necessary through guidance, the general food category (as specified in 21 CFR 170.3)
– Timely updates

• Failing to register is a prohibited act
– food offered for import from an unregistered foreign facility shall be held at the port of entry until facility is registered

• FDA is required to:
– Notify registrants of receipt and assign each facility a unique registration number;
– Maintain an up-to-date list;
– Protect the list and registration information from disclosure. (This information is not discloseable under the Freedom of Information Act)
• FDA may encourage electronic registration
• Will automatically go into effect on December 12, 2003, until superseded by final regulations

Sec. 306 Maintenance and Inspection of Records for Foods

Provides FDA access to records if those records are needed to determine if an article of food - domestic or imported - is adulterated and presents a serious risk to public health. Also provides authority to require the creation and maintenance of certain records. FDA will develop regulations.
• Access applies to all records relating to the manufacture, processing, packing, distribution, receipt, holding, or importation of food
• Creation and maintenance of records:
– By regulation, may establish requirements regarding the creation and maintenance of records to be able to identify the immediate previous source and the immediate subsequent recipient
– The regulations may require the records to be maintained for up to two years
– FDA must consider the size of the business when developing the regulations
– Final rules by December 12, 2003
• Excludes farms and restaurants
• Excludes from access sensitive information such as recipes, financial data, personnel data, research data, or sales data
• Secretary to ensure protection from disclosure of sensitive information
• Refusing to permit access to or copying of any required record or to failing to establish or maintain any required record is a prohibited act.

Sec. 307: Prior Notice of Imported Food Shipments

Requires that prior notice be provided to FDA about shipments of food being offered for import into the U.S. in order to better enable the food to be inspected at ports of entry

• Notice must provide the:

– identity of the food article;
– manufacturer and shipper;
– grower (if known);
– country of origin;
– country from which it was shipped; and,
– anticipated port of entry

• If notice is not provided, the article will be refused admission into the U.S.
• If inadequate notice is provided, the article will be held at the port of entry until proper notice is provided.
• Failure to provide notice is a prohibited act
• Regulations to specify the period of advance notice; may not exceed 5 days
• Default time period of not less than 8 hours nor more than 5 days self-executes if final regulations are not in place by December 12, 2003

Sec. 308 Authority to Mark Articles Refused Admission into United States
Provides for the marking of food that has been refused entry into the U.S. with a label that clearly and conspicuously bears the statement,

“UNITED STATES: REFUSED ENTRY”
Sec. 308 Authority to Mark Articles Refused Admission into United States (continued)
• Marking to be done at owner’s expense

• If an importer tries to re-enter refused articles, it will be misbranded if:
– it fails to bear the required refused entry label;
– presents a threat of serious adverse health consequences or death to humans or animals; and
– FDA notified the owner that the label is required and that the food presents such a threat.

Sec. 309 Prohibition Against Port Shopping

Deems food adulterated if a food is offered for import that previously has been refused admission unless the person reoffering the food establishes that the article is in compliance with the Act

Sec. 310 Notices to States Regarding Imported Food

Provides for the notification to States when there is credible evidence or information that a shipment of food presents a threat of serious adverse health consequences or death to humans or animals

Sec. 311: Grants to States for Inspections

Provides for grants to States, territories, and Indian tribes that undertake examinations, inspections, and investigations, and related activities. Not limited to foods.

Sec. 312: Surveillance and Information Grants and Authorities

Provides for grants to States and Indian tribes to expand participation in networks (such as PulseNet) to enhance Federal, State, and local food safety efforts; and, to establish and maintain the food safety surveillance, technical, and laboratory capacity needed for participation.

Sec. 313: Surveillance of Zoonotic Diseases

Requires the Secretary of Health and Human Services and the Secretary of Agriculture to coordinate surveillance of zoonotic diseases.

Sec. 314: Authority to Commission Other Federal Officials to Conduct Inspections

Authorizes FDA to commission employees of other Federal agencies to conduct examinations and inspections on behalf of FDA. Not limited to foods, but restricted to facilities or other locations that are jointly regulated.

TITLE III
Subtitle B - Protection of Drug Supply

Sec. 321: Requires annual electronic registration and listing for foreign establishments importing or offering for import to the US drugs or devices and requires additional information on importers

Sec. 322: Creates a new Import for Export provision, detailing the process for submitting information in order to import products intended solely for processing or incorporation into a product for export. Includes imported drug and devices components, food additives, color additives, and dietary supplements.

• At time of importation, a statement must be provided that includes:
– that the article is intended to be further processed or incorporated into a drug, biological product, device, food, food additive, color additive, or dietary supplement;
– identity of the manufacturer of the article, processor, packer, distributor, or other entity in chain of possession from manufacturer to importer.

It is a prohibited act to:

– make false statements;
– fail to keep or submit required records;
– release into interstate commerce any article or portion;
– fail to export or destroy.

Summary Of HHS/FDA Regulatory Deadlines
• September 9, 2002: Sec. 322 - Import Components for Export - Guidance anticipated
• December 8, 2002: Sec. 321 -Electronic Registration for foreign establishments importing drugs and devices
• December 2002: Anticipate issuing proposed regulations for Sections 303, 305, 306, 307.
• October 12, 2003: Anticipate issuing draft final regulations
• December 12, 2003: Effective date for final regulations for:
• Sec. 303: Administrative Detention
• Sec. 305: Food Facility Registration
• Sec. 306: Establishment and Maintenance of Records
• Sec. 307: Prior Notice of Food Shipments

Source: FDA