HR 2749

To amend the Federal Food, Drug, and Cosmetic Act to improve the safety of food in the global market, and for other purposes.

Sponsor: John D. Dingell (D) MI

Status: Passed

Govit

Gov Voted Yes 66%

0 COMMENTS

Details

Gov Votes

Member Votes

Take Action:

email friends

email congress

link

Summary:

6/8/2009--Introduced.Food Safety Enhancement Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to set forth provisions governing food safety. Requires each food facility to: (1) conduct a hazard analysis; (2) implement preventive controls; and (3) implement a food safety plan. Requires the Secretary of Health and Human Services to: (1) issue science-based performance standards to minimize the hazards from foodborne contaminants; (2) establish science-based standards for raw agricultural commodities; (3) inspect facilities at a frequency determined pursuant to a risk-based schedule; (4) establish a food tracing system; (5) assess fees relating to food facility reinspection and food recall; and (6) establish a program for accreditation of laboratories that perform analytical testing of food for import or export. Authorizes the Secretary to: (1) order an immediate cessation of distribution, or a recall, of food; (2) establish an importer verification program; and (3) quarantine food in any geographic area within the United States. Defines the term "color additive" to include carbon monoxide that may affect the color of fresh meat, poultry products, or seafood. Requires country of origin labeling on food and annual registration of importers. Provides for unique identifiers for food facilities and food importers. Deems a food to be adulterated if an inspection is delayed or refused. Requires the Secretary to establish a corps of inspectors dedicated to inspections of foreign food facilities. Sets forth provisions governing the reorganization of Food and Drug Administration (FDA) field laboratories and district offices. Gives the Commissioner of Food and Drugs subpoena authority with respect to a food proceeding. Establishes whistleblower protections.

Text of Legislation:

HR 2749 IH

111th CONGRESS

1st Session

H. R. 2749

To amend the Federal Food, Drug, and Cosmetic Act to improve the safety of food in the global market, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

June 8, 2009

Mr. DINGELL (for himself, Mr. WAXMAN, Mr. PALLONE, Mr. STUPAK, Ms. DEGETTE, and Ms. SUTTON) introduced the following bill; which was referred to the Committee on Energy and Commerce

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to improve the safety of food in the global market, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ‘Food Safety Enhancement Act of 2009’.

SEC. 2. TABLE OF CONTENTS.

The table of contents of this Act is as follows:

Sec. 1. Short title.

Sec. 2. Table of contents.

Sec. 3. References.

Sec. 4. Rule of construction.

TITLE I--FOOD SAFETY

Subtitle A--Prevention

Sec. 101. Changes in registration of food facilities.

Sec. 102. Hazard analysis, risk-based preventive controls, and food safety plan.

Sec. 103. Performance standards.

Sec. 104. Safety standards for fresh produce and certain other raw agricultural commodities.

Sec. 105. Risk-based inspection schedule.

Sec. 106. Access to records.

Sec. 107. Traceability of food.

Sec. 108. Reinspection and food recall fees applicable to facilities.

Sec. 109. Certification and accreditation.

Sec. 110. Testing by accredited laboratories.

Sec. 111. Notification, nondistribution, and recall of adulterated or misbranded food.

Sec. 112. Reportable food registry; exchange of information.

Sec. 113. Safe and secure food importation program.

Sec. 114. Infant formula.

Subtitle B--Intervention

Sec. 121. Public health assessment system.

Sec. 122. Public education and advisory system.

Sec. 123. Research.

Subtitle C--Response

Sec. 131. Procedures for seizure.

Sec. 132. Administrative detention.

Sec. 133. Quarantine authority for foods.

Sec. 134. Criminal penalties.

Sec. 135. Civil penalties for violations relating to food.

Sec. 136. Improper import entry filings.

TITLE II--MISCELLANEOUS

Sec. 201. Treatment of carbon monoxide used to preserve color of meat, poultry products, or seafood as color additive.

Sec. 202. Food substances generally recognized as safe.

Sec. 203. Country of origin labeling; disclosure of source of ingredients.

Sec. 204. Exportation certificate program.

Sec. 205. Registration for commercial importers of food; fee.

Sec. 206. Unique identification number for food facilities, importers, custom brokers, and filers.

Sec. 207. Prohibition against delaying, limiting, or refusing inspection.

Sec. 208. Dedicated foreign inspectorate.

Sec. 209. Plan and review of continued operation of field laboratories.

Sec. 210. False or misleading reporting to FDA.

Sec. 211. Subpoena authority.

Sec. 212. Whistleblower protections.

Sec. 213. Extraterritorial jurisdiction.

SEC. 3. REFERENCES.

Except as otherwise specified, whenever in this Act an amendment is expressed in terms of an amendment to a section or other provision, the reference shall be considered to be made to a section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

SEC. 4. RULE OF CONSTRUCTION.

Nothing in this Act or the amendments made by this Act shall be construed to prohibit or limit--

(1) any cause of action under State law; or

(2) the introduction of evidence of compliance or noncompliance with the requirements of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

TITLE I--FOOD SAFETY

Subtitle A--Prevention

SEC. 101. CHANGES IN REGISTRATION OF FOOD FACILITIES.

(a) Misbranding- Section 403 (21 U.S.C. 343) is amended by adding at the end the following:

‘(z) If it was manufactured, processed, packed, or held in a facility that is not duly registered under section 415, including a facility whose registration is canceled or suspended under such section.’.

(b) Annual Registration-

(1) IN GENERAL- Section 415(a) (21 U.S.C. 350d(a)) is amended--

(A) in the first sentence of paragraph (1)--

(i) by striking ‘require that’ and inserting ‘require that, on or before December 31 of each year,’; and

(ii) by striking ‘food for consumption in the United States’ and inserting ‘food for consumption in the United States or for export from the United States’;

(B) in subparagraphs (A) and (B) of paragraph (1), by inserting ‘and pay the registration fee required under section 743’ after ‘submit a registration to the Secretary’ each place it appears;

(D) in paragraph (4), by inserting after the first sentence the following: ‘The Secretary shall remove from such list the name of any facility that fails to reregister in accordance with this section, that fails to pay the registration fee required under section 743, or whose registration is canceled by the registrant, canceled by the Secretary in accordance with this section, or suspended by the Secretary in accordance with this section.’.

(2) CONTENTS OF REGISTRATION- Paragraph (2) of section 415(a) (21 U.S.C. 350d(a)), as amended by paragraph (1), is amended by striking ‘containing information’ and all that follows and inserting the following: ‘containing information that identifies the following:

‘(A) The name, address, and emergency contact information of the facility being registered.
‘(B) The primary purpose and business activity of the facility, including the dates of operation if the facility is seasonal.
‘(C) The general food category (as defined by the Secretary by guidance) of each food manufactured, processed, packed, or held at the facility.
‘(D) All trade names under which the facility conducts business related to food.
‘(E) The name, address, and 24-hour emergency contact information of the United States distribution agent for the facility, which agent shall have access to the information required to be maintained under section 414(d) for food that is manufactured, processed, packed, or held at the facility.
‘(F) If the facility is located outside of the United States, the name, address, and emergency contact information for a United States agent.
‘(G) The unique facility identifier of the facility, as specified under section 911.
‘(H) Such additional information pertaining to the facility as the Secretary may require by regulation.

The registrant shall notify the Secretary of any change in the submitted information not later than 30 days after the date of such change, unless otherwise specified by the Secretary.’.

(3) SUSPENSION AND CANCELLATION AUTHORITY- Section 415(a) (21 U.S.C. 350d(a)), as amended by paragraphs (1) and (2), is further amended by adding at the end the following:

‘(5) SUSPENSION OF REGISTRATION-
‘(A) IN GENERAL- The Secretary may suspend the registration of any facility registered under this section for a violation of this Act that could result in serious adverse health consequences or death to humans or animals.
‘(B) NOTICE OF SUSPENSION- Suspension of a registration shall be preceded by--
‘(i) notice to the facility of the intent to suspend the registration; and
‘(ii) an opportunity for an informal hearing, as defined in guidance or regulations issued by the Secretary, concerning the suspension of such registration for such facility.
‘(C) REQUEST- The owner, operator, or agent in charge of a facility whose registration is suspended may request that the Secretary vacate the suspension of registration when such owner, operator, or agent has corrected the violation that is the basis for such suspension.
‘(D) VACATING OF SUSPENSION- If, based on an inspection of the facility or other information, the Secretary determines that adequate reasons do not exist to continue the suspension of a registration, the Secretary shall vacate such suspension.
‘(6) CANCELLATION OF REGISTRATION-
‘(A) IN GENERAL- Not earlier than 10 days after providing the notice under subparagraph (B), the Secretary may cancel a registration that the Secretary determines was not updated in accordance with this section or otherwise contains false, incomplete, or inaccurate information.
‘(B) NOTICE OF CANCELLATION- Cancellation shall be preceded by notice to the facility of the intent to cancel the registration and the basis for such cancellation.
‘(C) TIMELY UPDATE OR CORRECTION- If the registration for the facility is updated or corrected no later than 7 days after notice is provided under subparagraph (B), the Secretary shall not cancel such registration.
‘(7) REPORT TO CONGRESS- Not later than March 30th of each year, the Secretary shall submit to the Congress a report, based on the registrations on or before December 31 of the previous year, on the following:
‘(A) The number of facilities registered under this section.
‘(B) The number of such facilities that are domestic.
‘(C) The number of such facilities that are foreign.
‘(D) The number of such facilities that are high-risk.
‘(E) The number of such facilities that are low-risk.
‘(F) The number of such facilities that hold food.’.

‘PART 6--FEES RELATING TO FOOD

Full Text of Legislation

Subject Name:

Agriculture and food

Administrative law and regulatory procedures

Agricultural trade

Business records

Civil actions and liability

Department of Health and Human Services

Employment discrimination and employee rights

Evidence and witnesses

Executive agency funding and structure

Food and Drug Administration (FDA)

Food industry and services

Food supply, safety, and labeling

Government information and archives

Government investigations

Hazardous wastes and toxic substances

Licensing and registrations

Trade restrictions

User charges and fees

All Actions:

Actions Date

Action Text

6/8/2009

Referred to the House Committee on Energy and Commerce.

6/9/2009

Referred to the Subcommittee on Health.

6/10/2009

Subcommittee Consideration and Mark-up Session Held.

6/11/2009

Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .

6/17/2009

Committee Consideration and Mark-up Session Held.

7/29/2009

Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 111-234.

7/29/2009

Mr. Dingell moved to suspend the rules and pass the bill, as amended.

7/29/2009

Considered under suspension of the rules.

7/29/2009

DEBATE - The House proceeded with forty minutes of debate on H.R. 2749.

7/29/2009

Rules Committee Resolution H. Res. 691 Reported to House. Rule provides for consideration of H.R. 2749 with 1 hour of general debate. Previous question shall be considered as ordered without intervening motions except motion to recommit with or without instructions. Measure will be considered read. Bill is closed to amendments. In lieu of the amendment in the nature of a substitute recommended by the Committee on Energy and Commerce now printed in the bill, the amendment in the nature of a substitute printed in the report of the Committee on Rules shall be considered as adopted. All points of order against consideration of the bill are waived except those arising under clause 9 or 10 of rule XXI.

7/29/2009

On motion to suspend the rules and pass the bill, as amended Failed by the Yeas and Nays: (2/3 required): 280 - 150 (Roll no. 657).

7/30/2009

Rule H. Res. 691 passed House.

7/30/2009

Considered under the provisions of rule H. Res. 691.

7/30/2009

Rule provides for consideration of H.R. 2749 with 1 hour of general debate. Previous question shall be considered as ordered without intervening motions except motion to recommit with or without instructions. Measure will be considered read. Bill is closed to amendments. In lieu of the amendment in the nature of a substitute recommended by the Committee on Energy and Commerce now printed in the bill, the amendment in the nature of a substitute printed in the report of the Committee on Rules shall be considered as adopted. All points of order against consideration of the bill are waived except those arising under clause 9 or 10 of rule XXI.

7/30/2009

DEBATE - The House proceeded with one hour of debate on H.R. 2749.

7/30/2009

DEBATE - The House continued with further debate on H.R. 2749.

7/30/2009

The previous question was ordered pursuant to the rule.

7/30/2009

Mr. Lucas moved to recommit with instructions to Energy and Commerce.

7/30/2009

DEBATE - The House proceeded with 10 minutes of debate on the Lucas(OK) motion to recommit with instructions. The instructions contained in the motion seek to require the bill to be reported back to the House with amendments, pending the reservation of a point of order.

7/30/2009

Mr. Dingell raised a point of order against the motion to recommit with instructions. Mr. Dingell stated that the provisions of the motion to recommit exceeds the scope of the bill. Overruled by the Chair.

7/30/2009

The previous question on the motion to recommit with instructions was ordered without objection.

7/30/2009

On motion to recommit with instructions Failed by the Yeas and Nays: 186 - 240 (Roll no. 679).

7/30/2009

On passage Passed by recorded vote: 283 - 142 (Roll no. 680).

8/3/2009

Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Titles:

To amend the Federal Food, Drug, and Cosmetic Act to improve the safety of food in the global market, and for other purposes.

Food Safety Enhancement Act of 2009