FDA - July PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002 July 2002

2 P.L Provisions 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)

3 IMPACT OF LEGISLATION ON FDA Primary impact for FDA concerns the food provisions of the Federal Food, Drug and Cosmetic Act (FD&C Act) although there are several important drug provisions. (This discussion excludes PDUFA provisions.) The definition of food includes food, food additives, dietary supplements and animal feed. There are a number of provisions that do not directly impact FDA and for which FDA does not have the Agency lead within the Department of Health and Human Services (DHHS) but FDA will be involved.

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

5 SUBTITLE A - NATIONAL PREPAREDNESS AND RESPONSE PLANNING, COORDINATING, AND REPORTING Sec. 101 – National preparedness and response –Secretary has to further develop and implement a coordinated preparedness plan Sec Assistant Secretary for Public Health Emergency Preparedness, National Disaster Medical System –creates Assistant Secretary; –responsible for coordination of emergency response activities within DHHS related to bioterrorism and other public health emergencies; and –National Medical Disaster System –required to conduct one exercise to test capability

6 SUBTITLE A - NATIONAL PREPAREDNESS AND RESPONSE PLANNING, COORDINATING, AND REPORTING (continued) Sec. 104 – Advisory Committees and Communications –Secretary to establish 2 advisory committees Children and Terrorism (composed of appropriate federal officials) Emergency Public Information and Communication (composed diverse group of experts) – –both committees must meet and make recommendations –recommendation for federal web site on bioterrorism Sec. 105 – Education of Health Care Personnel: Training Regarding Pediatric Issues

7 SUBTITLE A - NATIONAL PREPAREDNESS AND RESPONSE PLANNING, COORDINATING, AND REPORTING (continued) Sec. 108 – Working Group –Secretary shall revise working group on Bioterrorism and Other Public Health Emergencies –group makes recommendations on responding to bioterrorist attacks and prioritizing countermeasures required to treat, prevent, identify exposure to biological agent or toxin, pathogen research, assessment of priorities, communication and strategies for decontamination

8 SUBTITLE B - STRATEGIC NATIONAL STOCKPILE; DEVELOPMENT PRIORITY COUNTERMEASURES Sec. 121 – Strategic National Stockpile –Secretary to coordinate with Secretary of Veterans Affairs –working group maintain stockpile –no disclosure of information on location Sec. 122 – Accelerated Approval of Priority Countermeasures –drugs and devices can be designated fast track products or granted priority review. Sec. 123 – Issuance of Rule on Animal Trials –COMPLETED Sec. 127 – Potassium Iodide –establish guidelines for stockpiling of potassium iodide and distribution and utilization of potassium iodide tablets in the event of a nuclear incident

9 SUBTITLE D - EMERGENCY AUTHORITIES; ADDITIONAL PROVISIONS Sec. 141 – Reporting Deadlines –in public emergency, Secretary can grant extensions/waivers of deadlines for data and report submissions required under law and may waive sanctions

10 SUBTITLE E - ADDITIONAL PROVISIONS Sec. 152 – Expanded Research by Secretary of Energy –Secretary of Energy and National Nuclear Security Administration are to expand, enhance and intensify research relevant to rapid detection and identification of pathogens likely to be used in a bioterrorism attack or other agents that may cause a public health emergency Sec. 159 – Public Access to Defibrillation Programs –create grant program for defibrillators

11 TITLE II ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS

12 SUBTITLE A - DEPARTMENT OF HEALTH AND HUMAN SERVICES Sec – Regulation of Certain Biological Agents and Toxins –requires extensive new lists with criteria considered by Secretary for registration of select agents –products approved or investigational under FD&C and PHS Act can be exempted –certain non-disclosure requirements –report to Congress –current regulations are deemed effective under new section

13 SUBTITLE B - DEPARTMENT OF AGRICULTURE Sec – Regulations of Certain Biological Agents and Toxins –similar to Section 201 but regulates select agents under jurisdiction of Department of Agriculture

14 SUBTITLE C - INTERAGENCY COORDINATION REGARDING OVERLAP AGENTS AND TOXINS Sec. 221 – Interagency Coordination –requires interagency coordination of secs. 201 and 212 to avoid overlap –MOU on notices, coverage, etc. are required between Secs. of DHHS and AG

15 SUBTITLE D - CRIMINAL PENALTIES REGARDING CERTAIN BIOLOGICAL AGENTS AND TOXINS Sec. 231 – Criminal Penalties

16 TITLE III PROTECTING SAFETY AND SECURITY OF FOOD AND DRUG SUPPLY Subtitle A - Protection of Food Supply

17 Sec. 301 FOOD SAFETY AND SECURITY STRATEGY President’s Council on Food Safety to develop a crisis communications and education strategy regarding bioterrorist threats to the food supply Expands entities to consult to include Secretaries of Transportation and Treasury

18 Sec. 301 FOOD SAFETY AND SECURITY STRATEGY (continued) strategy shall address: –threat assessments; –technologies and procedures for securing facilities and modes of transportation; –response and notification procedures; and –risk communications to the public

19 Sec. 302 PROTECTION AGAINST ADULTERATION OF FOOD amends 801 to direct Secretary to give high priority to increasing imported food inspections with greatest priority for inspections to detect intentional adulteration requires high priority to improving information management systems for imported foods to: –improve ability to allocate resources; –detect intentional adulteration; and –facilitate the importation of food that is in compliance requires improved linkages with other Federal, state, and tribal food safety agencies

20 Sec. 302 PROTECTION AGAINST ADULTERATION OF FOOD (continued) requires research to develop improved rapid testing and sampling methodologies to detect adulteration requires coordination as appropriate on the research requires annual report to Congress describing progress made in research By December 12, 2002 requires the Secretary to complete threat assessment and submit a report to Congress

21 Sec. 303 ADMINISTRATIVE DETENTION Detention: amends 304 to authorize an officer or qualified employee of FDA to order detention of food if there is credible evidence or information that the food presents threat of serious adverse health consequences or death detention must be approved at district director level or higher, as designated by the Secretary detention may not exceed 20 days, unless more time (not to exceed 30 days) is necessary for the Secretary to pursue a seizure or injunction detention may require marking or labeling as detained requires removal to secure facility as appropriate

22 Sec. 303 ADMINISTRATIVE DETENTION (continued) Detention (continued): establishes process that requires Secretary, after an opportunity for informal hearing, to decide appeals in 5 days –subject to judicial review; –process terminates if Secretary files for seizure or injunction; –detention order terminates if Secretary does not comply with appeal requirements prohibited act to transfer an article of food in violation of detention order or remove or alter any required mark or label

23 Sec. 303 ADMINISTRATIVE DETENTION (continued) Temporary Hold: amends 801 to provide for temporary holds at ports of entry request Treasury 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 and the officer needs more time to inspect, examine, or investigate be approved by district director level or higher removal to secure facility as appropriate notification of port-of-entry State

24 Sec. 304 DEBARMENT FOR REPEATED OR SERIOUS FOOD IMPORT VIOLATIONS amends Sec. 306(b) to establish debarment for persons convicted of a felony related to food importation or for persons who have 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 prohibited act to import or offer for import food by, with the assistance of, or at the direction of a debarred person amends Sec. 801 to require that food offered for import by a debarred person be held at the port of entry, at a secure facility as appropriate, and not transferred article may be delivered to a non-debarred person if person establishes article is in compliance.

25 Sec. 305 REGISTRATION OF FOOD FACILITIES requires registration of domestic and foreign food facilities 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 limits foreign facilities to those whose products are exported to the U.S. without further processing or packaging outside the U.S.

26 Sec. 305 REGISTRATION OF FOOD FACILITIES (continued) owner, operator, or agent in charge shall submit the registration foreign facilities shall provide name of US agent registration is one-time rather than annual registrants to notify FDA of changes in a timely manner registration shall include names and addresses of each facility, all trade names and, when necessary, the general food category (as specified in 21 CFR 170.3) Secretary to notify registrants of receipt and assign each facility a number

27 Sec. 305 REGISTRATION OF FOOD FACILITIES (continued) requires Secretary to maintain up-to-date list specifies list and registration information not subject to disclosure failure to register a prohibited act amends Sec. 801 to require that an article of food offered for import from an unregistered foreign facility be held at the port of entry until facility is registered Secretary may encourage electronic registration final rules by December 12, Self-executing on December 12, 2003 until superseded by final regulations

28 Sec. 306 MAINTENANCE AND INSPECTION OF RECORDS FOR FOODS authorizes the Secretary to have access to certain records when there is a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals applies to all records relating to the manufacture, processing, packing, distribution, receipt, holding, or importation of food excludes farms and restaurants limits requirement to establish records for traceback to the immediate previous source and the immediate subsequent recipient

29 Sec. 306 MAINTENANCE AND INSPECTION OF RECORDS FOR FOODS (continued) excludes information such as recipes, financial data, personnel data, research data, and sales data limits recordkeeping requirement to 2 years Secretary to ensure protection from disclosure of sensitive information amends Sec. 704 to reflect the requirement to provide the Secretary with access prohibited act to refuse to permit access to or copying of any required record or to fail to establish or maintain any required record final rules by December 12, 2003; can consider size of business in promulgating the regulations

30 Sec. 307 PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS amends 801 to require prior notice of imported food shipments notice to provide the: –article; –manufacturer and shipper; – grower (if known); –country of origin; –country from which it was shipped; and –anticipated port of entry if notice not provided, article refused admission

31 Sec. 307 PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS (continued) if inadequate notice provided, article held at the port of entry until proper notice is provided; requires Secretary to determine whether there is any credible evidence or information indicating that the article presents a threat of serious adverse health consequences or death to humans or animals prohibited act to fail to provide notice requires the Secretary, after consultation with Treasury, to issue regulations to specify the period of advance notice; may not exceed 5 days final regulations by December 12, 2003; provides default time period (not less than 8 hours nor more than 5 days) until final regulations effective)

32 Sec. 308 AUTHORITY TO MARK ARTICLES REFUSED ADMISSION INTO UNITED STATES amends 801 to authorize the Secretary to require refused food (other than food required to be destroyed) to be marked “UNITED STATES: REFUSED ENTRY” marking to be done at owner’s expense food misbranded if: –it fails to bear the required label; –food 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

33 Sec. 309 PROHIBITION AGAINST PORT SHOPPING food adulterated if a food is offered for import that has been previously refused admission unless the person reoffering the food establishes that the article is in compliance

34 Sec. 310 NOTICES TO STATES REGARDING IMPORTED FOOD notify States when there is credible evidence or information that a shipment presents a threat of serious adverse health consequences or death to humans or animals notice to be given to State in which the food is held or will be held and the States in which the manufacturer, packer, or distributor of the food is located request the State to take appropriate action to protect the public health

35 Sec. 311 GRANTS TO STATES FOR INSPECTIONS grants to States, territories, and Indian tribes that undertake examinations, inspections, and investigations, and related activities under 702 not limited to foods grants to the States to assist them with the costs of taking appropriate action after receiving notification under Sec. 310 above

36 Sec. 312 SURVEILLANCE AND INFORMATION GRANTS AND AUTHORITIES grants to States and Indian tribes to expand participation in networks (such as PulseNet) to enhance Federal, State, and local food safety efforts establishing and maintaining the food safety surveillance, technical, and laboratory capacity needed for participation

37 Sec. 313 SURVEILLANCE OF ZOONOTIC DISEASES Secretaries of DHHS and Agriculture to coordinate surveillance of zoonotic diseases

38 Sec. 314 AUTHORITY TO COMMISSION OTHER FEDERAL OFFICIALS TO CONDUCT INSPECTIONS amends 702 to authorize the Secretary to commission other Federal employees to do examinations and inspections not limited to foods requires a memorandum of understanding between both agencies which must address training and reimbursement is restricted to facilities or other locations that are jointly regulated

39 TITLE III PROTECTING SAFETY AND SECURITY OF FOOD AND DRUG SUPPLY Subtitle B - Protection of Drug Supply

40 Sec. 321 – ANNUAL REGISTRATON OF FOREIGN MANUFACTURERS; SHIPPING INFORMATION; DRUG AND DEVICE LISTING amends §510, FD&C Act requires yearly electronic registration for: –foreign establishments with information on importers known to the establishments and names of person who imports or offers for imports drugs or devices to US articles can be refused admission and held at border until submission of statement of registration the article can be held until appropriate statement of registration submitted failure to register is a prohibited act provisions take effect December 8, 2002

41 Sec. 322 – REQUIREMENT OF ADDITIONAL INFORMATION REGARDING IMPORT COMPONENTS INTENDED FOR USE IN EXPORT PRODUCTS creates new §801(d)(3), FD&C Act - Import for Export provision (some similarity to old section) at time of importation, a statement must be provided with the following information: –article is intended to be further processed or incorporated into a drug, biological product, device, food, food additive, color additive or dietary supplement that will be exported under 802(e) or 351(h) PHS Act; –identifies manufacturer of article and processor, packer, distributor, or other entity in chain of possession from manufacturer to importer; –certificate of analysis as necessary to identify article unless device or falls under 801 (d)(4) - blood and blood components

42 Sec. 322 – REQUIREMENT OF ADDITIONAL INFORMATION REGARDING IMPORT COMPONENTS INTENDED FOR USE IN EXPORT PRODUCTS (continued) also: –a bond must be executed for payment of liquidated damages required by Sec. of Treasury; –the article must be used in accordance with statement submitted or destroyed; –records must be maintained on use, destruction, exportation and compliance and provided on request to Sec. of HHS articles can be refused admission if the Sec. determines credible evidence or information indicating further processing is not intended or not incorporated into product to be exported

43 Sec. 322 – REQUIREMENT OF ADDITIONAL INFORMATION REGARDING IMPORT COMPONENTS INTENDED FOR USE IN EXPORT PRODUCTS (continued) prohibited acts include: –knowingly making false statements in any of the information submitted; –failure to keep records required; –failure to submit records required; –release into interstate commerce of any article or portion (except for export); –failure to export or destroy effective September 9, 2002