U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
July 17, 2002


Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 (PL107-188)

Letter from Center Director
Attachment A: Summary Of Title III, Subtitle A and Subtitle B
Attachment B: Contact Information


Dear Colleague, FDA Foods Community:

The events of September 11, 2001, reinforced the need to enhance the security of the United States food supply. Congress responded by passing the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 ("the Bioterrorism Act" or "the Act") (PL107-188), which President Bush signed into law on June 12, 2002.(1) The Act is divided into the following five titles:

The purpose of this letter is: (1) to give you an overview of the four provisions in Title III, Subtitle A (Protection of the Food Supply), which require the Food and Drug Administration (FDA) to issue regulations in an expedited time period; (2) to inform you how the Department and FDA will be proceeding; and (3) to solicit comment on areas of concern to you and suggestions for how best to communicate those concerns to us.

A. Provisions Requiring Regulations

Attachment A provides an informal summary of the provisions in Title III, Subtitle A of the Bioterrorism Act. As noted, the Secretary, through the FDA, is required to propose and issue final regulations for the following four provisions:

Unless exempted, these provisions apply to all facilities for all types of food products regulated by FDA, including dietary supplements.

B. FDA's Regulation Development Plans

While the statute establishes ambitious deadlines for each of the above provisions, I want to underscore that the Secretary has made it clear that he expects FDA to meet them. Our goal is to publish proposed regulations by the end of this calendar year, and we plan to offer at least a 60-day comment period.

We also are committed to receiving and considering the input from stakeholders as we develop the proposed and final regulations. Before issuing these proposed rules, FDA will seek to identify stakeholders' concerns and potential options for addressing them. During the comment period, we plan to hold several public meetings at various locations across the country to explain the proposed regulatory requirements, answer questions, and receive additional comment.

We also have opened public dockets for each regulation and are ready to receive input from you now. Comments would be most helpful if you not only identify any concerns you may have, but also provide both your recommended solution and any supporting data, if applicable. Also, to the extent feasible, we would appreciate receiving any initial comments you may have by August 30, 2002. Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. We request that you submit two copies of any written comments, except that individuals may submit one copy. Please ensure that you include in your submission the docket number that applies to your comment from the list below:

  • Section 305 (Registration)
Docket No. 02N-0276
  • Section 305 (Recordkeeping)
Docket No. 02N-0277
  • Section 307 (Prior Notice)
Docket No. 02N-0278
  • Section 303 (Detention)
Docket No. 02N-0275

If you would like to review comments FDA has received, you may do so at the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

Within the FDA, Ms. Linda Skladany, FDA's Senior Associate Commissioner for External Relations, will serve as the focal point for our outreach efforts. The Center for Food Safety and Applied Nutrition (CFSAN) will take the lead for the regulations development process. Mr. L. Robert Lake, CFSAN's Director of the Office of Regulations and Policy, will serve as senior manager of this effort. Ms. Leslye M. Fraser, CFSAN's Associate Director for Regulations, will serve as the overall lead for the regulations workgroups. Additional contact information is contained in Attachment B.

Lastly, many of the remaining provisions in Title III, Subtitle A of the Bioterrorism Act are effective now. Consistent with our good guidance practice (GGP) regulations, 21 CFR 10.115, FDA plans to issue guidance documents for several of these provisions prior to implementing them broadly. Please note that if FDA deems it necessary to use this new statutory authority to protect the public health prior to issuing written guidance, it will do so on a case-by-case basis after consulting with senior officials in the affected District and within Headquarters.

I hope that you have found this information helpful. Again, the Secretary, Dr. Crawford and I are committed to meeting the statutory deadlines required to implement the provisions of the Bioterrorism Act intended to further protect the safety of the food supply.

Sincerely,

 

Joseph A. Levitt
Director
Center for Food Safety and Applied Nutrition

cc: Dr. Lester Crawford, Deputy Commissioner


1You may obtain a full copy of the Act at http://thomas.loc.gov/, and searching with Bill number H.R. 3448.


Attachment A

Summary Of Title III, Subtitle A
Of The Public Health Security And Bioterrorism
Preparedness And Response Act Of 2002

Title III - Protecting Safety And Security Of Food And Drug Supply

Subtitle A - Protection of Food Supply


Sec. 301. Food Safety and 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 Facilities

Sec. 306. Maintenance and Inspection of Records for Foods

Sec. 307. Prior Notice of Imported Food Shipments

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

Sec. 309. Prohibition Against Port Shopping

Sec. 310. Notices to States Regarding Imported Food

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 Officials to Conduct Inspections

Sec. 315. Rule of Construction

Subtitle B - Protection of Drug Supply

Sec. 322. Requirement of Additional Information Regarding Import Components Intended for Use in Export Products


Attachment B

Contact Information for Implementing the Bioterrorism Act

Mailing Address for Outreach Efforts:

Ms. Linda A. Skladany
Senior Associate Commissioner for External Relations
Food and Drug Administration
5600 Fishers Lane (HF-10)
Rockville, MD 20857
Phone: (301) 827-3330
Fax: (301) 827-3052

Mailing Address for Contacting Regulatory Leads:

Food and Drug Administration
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway
College Park, MD 20740

Senior Manager

Mr. L. Robert Lake, Esq.
Director of Regulations and Policy
Mail Code HFS-4
Phone: (301) 436-2379
Fax: (301) 436-2637

Overall Lead

Ms. Leslye M. Fraser, Esq.
Associate Director for Regulations
Mail Code HFS-4
Phone:(301) 436-2378
Fax:(301) 436-2637

Day-to-Day Leads for Regulatory Workgroups:

Section 305: Registration Workgroup
Ms. Leslye M. Fraser, Esq.
(Contact Information above)

Section 306: Recordkeeping Workgroup
Dr. Nega Beru
Mail Code HFS-305
Phone: (301) 436-1400
Fax: (301) 436-2651

Section 307: Prior Notice Workgroup
Ms. Mary Ayling
Mail Code HFS-032
Phone: (301) 436-2131
Fax: (301) 436-2605

Section 303: Detention Workgroup
Ms. Marquita Steadman, Esq.
Mail Code: HFS-007
Phone: (301) 827-6733
Fax: (301) 480-5730


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