Text of H.R. 2749 (111th): Food Safety Enhancement Act of 2009 (Referred to Senate Committee version)

IIB

111th CONGRESS

1st Session

H. R. 2749

IN THE SENATE OF THE UNITED STATES

August 3, 2009

Received; read twice and referred to the Committee on Health, Education, Labor, and Pensions

AN ACT

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

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

The table of contents of this Act is as follows:

Sec. 1. Short title.

Sec. 2. Table of contents.

Sec. 3. References.

Sec. 4. Rules of construction.

Sec. 5. USDA exemptions.

Sec. 6. Alcohol-related facilities.

Title I—Food Safety

Subtitle A—Prevention

Sec. 101. Changes in registration of food facilities.

Sec. 102. Hazard analysis, risk-based preventive controls, food safety plan, finished product test results from category 1 facilities.

Sec. 103. Performance standards.

Sec. 104. Safety standards for 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. Surveillance.

Sec. 122. Public education and advisory system.

Sec. 123. Research.

Subtitle C—Response

Sec. 131. Procedures for seizure.

Sec. 132. Administrative detention.

Sec. 133. Authority to prohibit or restrict the movement of food.

Sec. 134. Criminal penalties.

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

Sec. 136. Improper import entry filings.

Title II—Miscellaneous

Sec. 201. Food substances generally recognized as safe.

Sec. 202. Country of origin labeling.

Sec. 203. Exportation certificate program.

Sec. 204. Registration for commercial importers of food; fee.

Sec. 205. Registration for customs brokers.

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

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. 214. Support for training institutes.

Sec. 215. Bisphenol A in food and beverage containers.

Sec. 216. Lead content labeling requirement for ceramic tableware and cookware.

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.).

(a)

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.).

(b)

Nothing in this Act or any amendment made by this Act shall be construed to—

(1)

alter the jurisdiction between the Secretary of Agriculture and the Secretary of Health and Human Services, under applicable statutes and regulations;

(2)

limit the authority of the Secretary of Health and Human Services to issue regulations related to the safety of food under—

(A)

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) as in effect on the day before the date of the enactment of this Act; or

(B)

the Public Health Service Act (42 U.S.C. 301 et seq.) as in effect on the day before the date of the enactment of this Act; or

(3)

impede, minimize, or affect the authority of the Secretary of Agriculture to prevent, control, or mitigate a plant or animal health emergency, or a food emergency involving products regulated under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.).

(a)

Food is exempt from the requirements of this Act to the extent that such food is regulated by the Secretary of Agriculture under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.).

(b)

Livestock and poultry that are intended to be presented for slaughter pursuant to the regulations by the Secretary of Agriculture under the Federal Meat Inspection Act or the Poultry Products Inspection Act are exempt from the requirements of this Act. A cow, sheep, or goat that is used for the production of milk is exempt from the requirements of this Act.

(c)

A facility is exempt from the requirements of this Act to the extent such facility is regulated as an official establishment by the Secretary of Agriculture under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act or under a program recognized by the Secretary of Agriculture as at least equal to Federal regulation under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act.

(d)

A farm is exempt from the requirements of this Act to the extent such farm raises animals from which food is derived that is regulated under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act.

(a)

With the exception of the amendments made by section 101(a) and (b) and section 113 of this Act, nothing in this Act, or the amendments made by this Act, shall be construed to apply to a facility that—

(1)

under the Federal Alcohol Administration Act (27 U.S.C. 201 et seq.) or chapter 51 of subtitle E of the Internal Revenue Code of 1986 (26 U.S.C. 5291 et seq.) is required to obtain a permit or to register with the Secretary of the Treasury as a condition of doing business in the United States; and

(2)

under section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d), as amended by this Act, is required to register as a facility because such facility is engaged in manufacturing, processing, packing, or holding 1 or more alcoholic beverages.

(b)

Subsection (a) shall not apply to a facility engaged in the distributing of any non-alcohol food, except that subsection (a) shall apply to a facility described in paragraphs (1) and (2) of subsection (a) that receives and distributes non-alcohol food provided such food is received and distributed—

(1)

in a prepackaged form that prevents any direct human contact with such food; and

(2)

in amounts that constitute not more than 5 percent of the overall sales of such facility, as determined by the Secretary of the Treasury.

(c)

This section shall not be construed to exempt any food, apart from distilled spirits, wine, and malt beverages, as defined in section 211 of the Federal Alcohol Administration Act (27 U.S.C. 211), from the requirements of this Act and the amendments made by this Act.

101.

(a)

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)

(1)

Paragraph (1) of section 415(b) (21 U.S.C. 350d(b)) is amended to read as follows:

(1)

(A)

The term facility means any factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food.

(B)

Such term does not include farms; private residences of individuals; restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer; or fishing vessels (except such vessels engaged in processing as defined in section 123.3(k) of title 21, Code of Federal Regulations, or any successor regulations).

(C)

(i)

The term retail food establishment means an establishment that, as its primary function, sells food products (including those food products that it manufactures, processes, packs, or holds) directly to consumers (including by Internet or mail order).

(ii)

Such term includes—

(I)

grocery stores;

(II)

convenience stores;

(III)

vending machine locations; and

(IV)

stores that sell bagged feed, pet food, and feed ingredients or additives over-the-counter directly to consumers and final purchasers for their own personal animals.

(iii)

A retail food establishment’s primary function is to sell food directly to consumers if the annual monetary value of sales of food products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers.

(D)

(i)

The term farm means an operation in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both.

(ii)

Such term includes—

(I)

such an operation that packs or holds food, provided that all food used in such activities is grown, raised, or consumed on such farm or another farm under the same ownership;

(II)

such an operation that manufactures or processes food, provided that all food used in such activities is consumed on such farm or another farm under the same ownership;

(III)

such an operation that sells food directly to consumers if the annual monetary value of sales of the food products from the farm or by an agent of the farm to consumers exceeds the annual monetary value of sales of the food products to all other buyers;

(IV)

such an operation that manufactures grains or other feed stuffs that are grown and harvested on such farm or another farm under the same ownership and are distributed directly to 1 or more farms for consumption as food by humans or animals on such farm; and

(V)

a fishery, including a wild fishery, an aquaculture operation or bed, a fresh water fishery, and a saltwater fishery.

(iii)

Such term does not include such an operation that receives manufactured feed from another farm as described in clause (ii)(IV) if the receiving farm releases the feed to another farm or facility under different ownership.

(iv)

The term harvesting includes washing, trimming of outer leaves of, and cooling produce.

(E)

The term consumer does not include a business.

(2)

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;

(C)

in the first sentence of paragraph (2), by inserting in electronic format after submit; and

(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..

(3)

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 1011.

(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.

(4)

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)

(A)

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)

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)

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)

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)

(A)

Not earlier than 10 days after providing the notice under subparagraph (B), the Secretary may cancel a registration if the Secretary determines that—

(i)

the registration was not updated in accordance with this section or otherwise contains false, incomplete, or inaccurate information; or

(ii)

the required registration fee has not been paid within 30 days after the date due.

(B)

Cancellation shall be preceded by notice to the facility of the intent to cancel the registration and the basis for such cancellation.

(C)

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)

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.

(8)

The authority conferred by this subsection to issue an order to suspend a registration or cancel a registration shall not be delegated to any officer or employee other than the Commissioner of Food and Drugs, the Principal Deputy Commissioner, the Associate Commissioner for Regulatory Affairs, or the Director for the Center for Food Safety and Applied Nutrition, of the Food and Drug Administration.

(c)

Chapter VII (21 U.S.C. 371 et seq.) is amended by adding at the end of subchapter C the following:

743.

(a)

(1)

Beginning in fiscal year 2010, the Secretary shall assess and collect an annual fee for the registration of a facility under section 415.

(2)

A fee under this section shall be payable—

(A)

for a facility that was not registered under section 415 for the preceding fiscal year, on the date of registration; and

(B)

for any other facility—

(i)

for fiscal year 2010, not later than the sooner of 90 days after the date of the enactment of this part or December 31, 2009; and

(ii)

for a subsequent fiscal year, not later than December 31 of such fiscal year.

(b)

(1)

The registration fee under subsection (a) shall be—

(A)

for fiscal year 2010, $500; and

(B)

for fiscal year 2011 and each subsequent fiscal year, the fee for fiscal year 2010 as adjusted under subsection (c).

(2)

The Secretary shall, not later than 60 days before the start of fiscal year 2011 and each subsequent fiscal year, establish, for the next fiscal year, registration fees under subsection (a), as described in paragraph (1).

(3)

Notwithstanding paragraph (1), a person who owns or operates multiple facilities for which a fee must be paid under this section for a fiscal year shall be liable for not more than $175,000 in aggregate fees under this section for such fiscal year.

(c)

For fiscal year 2011 and each subsequent fiscal year, the fee amount under subsection (b)(1) shall be adjusted by the Secretary by notice, published in the Federal Register, to reflect the greater of—

(1)

the total percentage change that occurred in the Consumer Price Index for all urban consumers (all items; U.S. city average) for the 12-month period ending June 30 preceding the fiscal year for which fees are being established;

(2)

the total percentage change for the previous fiscal year in basic pay under the General Schedule in accordance with section 5332 of title 5, United States Code, as adjusted by any locality-based comparability payment pursuant to section 5304 of such title for Federal employees stationed in the District of Columbia; or

(3)

the average annual change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 5 years of the preceding 6 fiscal years.

The adjustment made each fiscal year under this subsection shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2010 under this subsection.

(d)

(1)

Fees under subsection (a) shall be refunded for a fiscal year beginning after fiscal year 2010 unless appropriations for salaries and expenses of the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) are equal to or greater than the amount of appropriations for the salaries and expenses of the Food and Drug Administration for fiscal year 2010 (excluding the amount of fees appropriated for such fiscal year) multiplied by the adjustment factor applicable to the fiscal year involved.

(2)

If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year because of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate, for registration under section 415 at any time in such fiscal year.

(3)

In this subsection, the term adjustment factor applicable to a fiscal year is the Consumer Price Index for all urban consumers (all items; United States city average) for October of the preceding fiscal year divided by such Index for October 2009.

(e)

(1)

Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation.

(2)

The fees authorized by this section—

(A)

shall be retained in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation, for such fiscal year; and

(B)

shall only be collected and available to defray the costs of food safety activities.

(3)

For each of fiscal years 2010 through 2014, there are authorized to be appropriated for fees under this section such sums as may be necessary.

(4)

For each fiscal year, the Secretary shall hold a public meeting on how fees collected under this section will be used to defray the costs of food safety activities in order to solicit the views of the regulated industry, consumers, and other interested stakeholders.

(f)

In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31, United States Code.

(g)

This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employees, and advisory committees not engaged in food safety activities, be reduced to offset the number of officers, employees, and advisory committees so engaged.

(h)

Beginning with fiscal year 2011, not later than 120 days after the end of each fiscal year for which fees are collected under this section, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected for such fiscal year.

(i)

In this section:

(1)

The term costs of food safety activities means the expenses incurred in connection with food safety activities for—

(A)

officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees and to contracts with such contractors;

(B)

laboratory capacity;

(C)

management of information, and the acquisition, maintenance, and repair of technology resources;

(D)

leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and

(E)

collecting fees under this section and accounting for resources allocated for food safety activities.

(2)

The term food safety activities means activities related to compliance by facilities registered under section 415 with the requirements of this Act relating to food (including research related to and the development of standards (such as performance standards and preventive controls), risk assessments, hazard analyses, inspection planning and inspections, third-party inspections, compliance review and enforcement, import review, information technology support, test development, product sampling, risk communication, and administrative detention).

(d)

(1)

The Secretary of Health and Human Services shall first impose the fee established under section 743 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (c), for fiscal years beginning with fiscal year 2010.

(2)

Not later than 180 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall modify the registration form under section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d) to comply with the amendments made by this section.

(3)

The amendments made by this section, other than subsections (b)(2) and (c), shall take effect on the date that is 30 days after the date on which such modified registration form takes effect, but not later than 210 days after the date of the enactment of this Act.

(4)

Section 743 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (c), does not authorize the assessment or collection of a fee for registration under section 415 of such Act (21 U.S.C. 360) occurring after fiscal year 2014.

102.

(a)

(1)

Section 402 (21 U.S.C. 342) is amended by adding at the end the following:

(j)

If it has been manufactured, processed, packed, transported, or held under conditions that do not meet the requirements of sections 418 and 418A.

(2)

Chapter IV (21 U.S.C. 341 et seq.) is amended by adding at the end the following:

418.

(a)

The owner, operator, or agent of a facility shall, in accordance with this section—

(1)

conduct a hazard analysis (or more than one if appropriate);

(2)

identify and implement effective preventive controls;

(3)

monitor preventive controls;

(4)

institute corrective actions when—

(A)

monitoring shows that preventive controls have not been properly implemented; or

(B)

monitoring and verification show that such controls were ineffective;

(5)

conduct verification activities;

(6)

maintain records of monitoring, corrective action, and verification; and

(7)

reanalyze for hazards.

(b)

(1)

The owner, operator, or agent of a facility shall evaluate whether there are any hazards, including hazards due to the source of the ingredients, that are reasonably likely to occur in the absence of preventive controls that may affect the safety, wholesomeness, or sanitation of the food manufactured, processed, packed, transported, or held by the facility, including—

(A)

biological, chemical, physical, and radiological hazards, natural toxins, pesticides, drug residues, filth, decomposition, parasites, allergens, and unapproved food and color additives; and

(B)

hazards that occur naturally or that may be unintentionally introduced.

(2)

The Secretary may, by regulation or guidance, identify hazards that are reasonably likely to occur in the absence of preventive controls.

(3)

The owner, operator, or agent of a facility shall identify and describe the hazards evaluated under paragraph (1) or identified under paragraph (2), to the extent applicable to the facility, in a hazard analysis.

(c)

(1)

The owner, operator, or agent of a facility shall identify and implement effective preventive controls to prevent, eliminate, or reduce to acceptable levels the occurrence of any hazards identified in the hazard analysis under subsection (b)(3).

(2)

(A)

The Secretary may establish by regulation or guidance preventive controls for specific product types to prevent unintentional contamination throughout the supply chain. The owner, operator, or agent of a facility shall implement any preventive controls identified by the Secretary under this paragraph.

(B)

Such regulation or guidance shall allow the owner, operator, or agent of a facility to implement an alternative preventive control to one established by the Secretary, provided that, in response to a request by the Secretary, the owner, operator, or agent can present to the Secretary data or other information sufficient to demonstrate that the alternative control effectively addresses the hazard, including meeting any applicable performance standard.

(C)

Subparagraph (B) shall not apply to any preventive control described in subparagraph (A), (B), or (E) of subsection (i)(2).

(d)

The owner, operator, or agent of a facility shall monitor the implementation of preventive controls under subsection (c) to identify any circumstances in which the preventive controls are not fully implemented or verification shows that such controls were ineffective.

(e)

The owner, operator, or agent of a facility shall establish and implement procedures to ensure that, if the preventive controls under subsection (c) are not fully implemented or are not found effective—

(1)

no affected product from such facility enters commerce; and

(2)

appropriate action is taken to reduce the likelihood of recurrence of the implementation failure.

(f)

The owner, operator, or agent of a facility shall ensure that—

(1)

the system of preventive controls identified under subsection (c) has been validated as scientifically and technically sound so that, if such system is implemented, the hazards identified in the hazard analysis under subsection (b)(3) will be prevented, eliminated, or reduced to an acceptable level;

(2)

the facility is conducting monitoring in accordance with subsection (d);

(3)

the facility is taking effective corrective actions under subsection (e); and

(4)

the preventive controls are effectively preventing, eliminating, or reducing to an acceptable level the occurrence of identified hazards, including through the use of environmental and product testing programs and other appropriate means.

(g)

(1)

The owner, operator, or agent of a facility shall—

(A)

review the evaluation under subsection (b) for the facility and, as necessary, revise the hazard analysis under subsection (b)(3) for the facility—

(i)

not less than every 2 years;

(ii)

if there is a change in the process or product that could affect the hazard analysis; and

(iii)

if the Secretary determines that it is appropriate to protect public health; and

(B)

whenever there is a change in the hazard analysis, revise the preventive controls under subsection (c) for the facility as necessary to ensure that all hazards that are reasonably likely to occur are prevented, eliminated, or reduced to an acceptable level, or document the basis for the conclusion that no such revision is needed.

(2)

Any revisions ordered by the Secretary under this subsection shall be ordered by the Secretary or an official designated by the Secretary. An official may not be so designated unless the official is the director of the district under this Act in which the facility involved is located, or is an official senior to such director.

(h)

The owner, operator, or agent of a facility shall maintain, for not less than 2 years, records documenting the activities described in subsections (a) through (g).

(i)

For purposes of this section:

(1)

The term facility means a domestic facility or a foreign facility that is required to be registered under section 415.

(2)

The term preventive controls means those risk-based procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, transporting, or holding of food would employ to prevent, eliminate, or reduce to an acceptable level the hazards identified in the hazard analysis under subsection (b)(3) and that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, transporting, or holding at the time of the analysis. Those procedures, practices, and processes shall include the following, as appropriate to the type of facility or food:

(A)

Sanitation procedures and practices.

(B)

Supervisor, manager, and employee hygiene training.

(C)

Process controls.

(D)

An allergen control program to minimize potential allergic reactions in humans from ingestion of, or contact with, human and animal food.

(E)

Good manufacturing practices.

(F)

Verification procedures, practices, and processes for suppliers and incoming ingredients, which may include onsite auditing of suppliers and testing of incoming ingredients.

(G)

Other procedures, practices, and processes established by the Secretary under subsection (c)(2).

(3)

A food safety hazard that is reasonably likely to occur is one for which a prudent person who, as applicable, manufactures, processes, packs, transports, or holds food, would establish controls because experience, illness data, scientific reports, or other information provides a basis to conclude that there is a reasonable possibility that the hazard will occur in the type of food being manufactured, processed, packed, transported, or held in the absence of those controls.

418A.

(a)

Before a facility (as defined in section 418(i)) introduces or delivers for introduction into interstate commerce any shipment of food, the owner, operator, or agent of the facility shall develop and implement a written food safety plan (in this section referred to as a food safety plan).

(b)

The food safety plan shall include each of the following elements:

(1)

The hazard analysis and any reanalysis conducted under section 418.

(2)

A description of the preventive controls being implemented under subsection 418(c), including those to address hazards identified by the Secretary under subsection 418(b)(2).

(3)

A description of the procedures for monitoring preventive controls.

(4)

A description of the procedures for taking corrective actions.

(5)

A description of verification activities for the preventive controls, including validation that the system of controls, if implemented, will prevent, eliminate, or reduce to an acceptable level the identified hazards, review of monitoring and corrective action records, and procedures for determining whether the system of controls as implemented is effectively preventing, eliminating, or reducing to an acceptable level the occurrence of identified hazards, including the use of environmental and product testing programs.

(6)

A description of the facility’s recordkeeping procedures.

(7)

A description of the facility’s procedures for the recall of articles of food, whether voluntarily or when required under section 422.

(8)

A description of the facility’s procedures for tracing the distribution history of articles of food, whether voluntarily or when required under section 414.

(9)

A description of the facility’s procedures to ensure a safe and secure supply chain for the ingredients or components used in making the food manufactured, processed, packed, transported, or held by such facility.

(10)

A description of the facility’s procedures to implement the science-based performance standards issued under section 419.

(3)

(A)

The Secretary of Health and Human Services (referred to in this subsection as the Secretary) shall issue guidance or promulgate regulations to establish science-based standards for conducting a hazard analysis, documenting hazards, identifying and implementing preventive controls, and documenting the implementation of the preventive controls, including verification and corrective actions under sections 418 and 418A of the Federal Food, Drug, and Cosmetic Act (as added by paragraph (2)).

(B)

In issuing guidance or regulations under subparagraph (A), the Secretary shall review international hazard analysis and preventive control standards that are in existence on the date of the enactment of this Act and relevant to such guidelines or regulations to ensure that the programs under sections 418 and 418A of the Federal Food, Drug, and Cosmetic Act (as added by paragraph (2) are consistent, to the extent the Secretary determines practicable and appropriate, with such standards.

(C)

The Secretary may, by regulation, exempt or modify the requirements for compliance under this section and the amendments made by this section with respect to facilities that are solely engaged in—

(i)

the production of food for animals other than man or the storage of packaged foods that are not exposed to the environment; or

(ii)

the storage of raw agricultural commodities for further distribution or processing.

(D)

The Secretary—

(i)

shall consider the impact of any guidance or regulations under this section on small businesses; and

(ii)

shall issue guidance to assist small businesses in complying with the requirements of this section and the amendments made by this section.

(4)

Nothing in this section or the amendments made by this section limits the authority of the Secretary under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the Public Health Service Act (42 U.S.C. 201 et seq.), as in effect on the day before the date of the enactment of this Act, to revise, issue, or enforce product- and category-specific regulations, such as the Seafood Hazard Analysis Critical Controls Points Program, the Juice Hazard Analysis Critical Control Program, and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards.

(5)

When implementing sections 418 and 418A of the Federal Food, Drug, and Cosmetic Act, as added by paragraph (2), the Secretary may take into account differences between food intended for human consumption and food intended for consumption by animals other than man.

(6)

(A)

The amendments made by subsection (a) and this subsection shall take effect 18 months after the date of the enactment of this Act.

(B)

Notwithstanding subparagraph (A)—

(i)

the amendments made by subsection (a) and this subsection shall apply to a small business (as defined by the Secretary) after the date that is 2 years after the date of the enactment of this Act; and

(ii)

the amendments made by subsection (a) and this subsection shall apply to a very small business (as defined by the Secretary) after the date that is 3 years after the date of the enactment of this Act.

(b)

(1)

Section 402 (21 U.S.C. 342), as amended by subsection (a), is amended by adding at the end the following:

(k)

If it is manufactured or processed in a facility that is in violation of section 418B.

(2)

Chapter IV (21 U.S.C. 341 et seq.), as amended, is further amended by adding at the end the following:

418B.

(a)

Beginning on the date specified in subsection (c), the Secretary shall require, after public notice and an opportunity for comment, the submission to the Secretary of finished product test results by the owner, operator, or agent of each category 1 facility subject to good manufacturing practices regulations documenting the presence of contaminants in food in the possession or control of such facility posing a risk of severe adverse health consequences or death.

(b)

The Secretary shall require submissions under subsection (a)—

(1)

as the Secretary determines feasible and appropriate; and

(2)

taking into consideration available data and information on the potential risks posed by the facility.

(c)

The date specified in this subsection is the sooner of—

(1)

the date of completion of the pilot projects and feasibility study under subsections (d) and (e); and

(2)

the date that is 2 years after the date of the enactment of this section.

(d)

The Secretary shall conduct 2 or more pilot projects to evaluate the feasibility of collecting positive finished product testing results from category 1 facilities, including the value and feasibility of reporting corrective actions taken when positive finished product test results are reported to the Secretary.

(e)

The Secretary shall assess the feasibility and benefits of the reporting by facilities subject to good manufacturing practices regulations of appropriate finished product testing results from category 1 facilities to the Secretary, including the extent to which the collection of such finished product testing results will help the Secretary assess the risk presented by a facility or product category.

(f)

Nothing in this section shall be construed—

(1)

to require the Secretary to mandate testing or submission of test results that the Secretary determines would not provide useful information in assessing the potential risk presented by a facility or product category; or

(2)

to limit the Secretary’s authority under any other provisions of law to require any person to provide access, or to submit information or test results, to the Secretary, including the ability of the Secretary to require field or other testing and to obtain test results in the course of an investigation of a potential food-borne illness or contamination incident.

(g)

In this section, the term category 1 facility means a category 1 facility within the meaning of section 704(h).

(c)

(1)

Section 402(j), as added by subsection (a), is amended by striking and 418A and inserting , 418A, or 418C.

(2)

Chapter IV (21 U.S.C. 341 et seq.), as amended, is further amended by adding at the end the following:

418C.

(a)

Before a facility (as defined in section 418(i)) introduces or delivers for introduction into interstate commerce any shipment of food, the owner, operator, or agent of the facility shall develop and implement a written food defense plan (in this section referred to as a food defense plan).

(b)

The food defense plan shall include each of the following elements:

(1)

A food defense assessment to identify conditions and practices that may permit a hazard that may be intentionally introduced, including by an act of terrorism. This assessment shall evaluate processing security, cybersecurity, material security (including ingredients, finished product, and packaging), personnel security, storage security, shipping and receiving security, and utility security.

(2)

A description of the preventive measures being implemented as a result of such assessment to minimize the risk of intentional contamination.

(3)

A description of the procedures to check for and identify any circumstances in which the preventive measures are not fully implemented or were ineffective.

(4)

A description of the procedures for taking corrective actions to ensure that when preventive measures have not been properly implemented or have been ineffective, appropriate action is taken—

(A)

to reduce the likelihood of recurrence of the failure; and

(B)

to assess the consequences of the failure.

(5)

A description of evaluation activities for the preventive measures, including a review of records provided for under paragraph (6) and procedures to periodically test the effectiveness of the plan.

(6)

A description of the facility’s record-keeping procedures, including records documenting implementation of the procedures under paragraphs (3), (4), and (5).

(c)

For purposes of this section, the term hazard that may be intentionally introduced, including by an act of terrorism means a hazard for which a prudent person who, as applicable, manufactures, processes, packs, transports, or holds food, would establish preventive measures because the hazard has been identified by a food defense assessment by application of—

(1)

a targeting assessment tool recommended by the Secretary by guidance; or

(2)

a comparable targeting assessment tool.

(d)

(1)

The Secretary may establish by regulation or guidance preventive measures for specific product types to prevent intentional contamination throughout the supply chain. The owner, operator, or agent of a facility shall implement any preventive measures identified by the Secretary under this paragraph.

(2)

Such regulation or guidance shall allow the owner, operator, or agent of a facility to implement an alternative preventive measure to one established by the Secretary, provided that, in response to a request by the Secretary, the owner, operator, or agent can present to the Secretary data or other information sufficient to demonstrate that the alternative measure effectively addresses the hazard.

(e)

(1)

The owner, operator, or agent of a facility shall—

(A)

review the food defense assessment under subsection (b)(1) for the facility and, as necessary, revise the food defense assessment under subsection (b)(1) for the facility—

(i)

not less than every 2 years;

(ii)

if there is a change in the process or product that could affect the food defense assessment; and

(iii)

if the Secretary determines that it is appropriate to protect public health; and

(B)

whenever there is a change in the food defense assessment, revise the preventive measures under subsection (b)(2) for the facility as necessary to ensure that for all hazards identified, the risk is minimized, or document the basis for the conclusion that no such revision is needed.

(2)

(f)

The owner, operator, or agent of a facility shall maintain, for not less than 2 years, records documenting the activities described in subsections (b) and (e).

(g)

(1)

An officer or employee of the Secretary shall have access to the food defense plan of a facility under section 414(a) only if the Secretary, through an official who is the director of the district under this Act in which the facility is located or an official who is senior to such a director, provides notice under section 414(a)(1)(C).

(2)

A food defense plan, and any information derived from such a plan, shall be exempt from disclosure under section 552 of title 5, United States Code.

(3)

Section 301(j) (21 U.S.C. 331(j)) is amended by inserting after entitled to protection the following: or a food defense plan, or any information derived from such a plan, under section 418C.

103.

(a)

Section 402 (21 U.S.C. 342), as amended by section 102, is amended by adding at the end the following:

(l)

If it has been manufactured, processed, packed, transported, or held under conditions that do not meet the standards issued under section 419.

(b)

Chapter IV (21 U.S.C. 341 et seq.), as amended by section 102(b), is further amended by adding at the end the following:

419.

(a)

The Secretary shall, not less frequently than every 2 years, review and evaluate epidemiological data and other appropriate sources of information, including research under section 123 of the Food Safety Enhancement Act of 2009, to identify the most significant food-borne contaminants and the most significant resulting hazards. The Secretary shall issue, as soon as practicable, through guidance or by regulation, science-based performance standards (which may include action levels) applicable to foods or food classes, as appropriate, to minimize to an acceptable level, prevent, or eliminate the occurrence of such hazards. Such standards shall be applicable to foods and food classes. Notwithstanding the timelines set forth in this paragraph, the Secretary shall as appropriate establish such science-based performance standards for identified contaminants as necessary to protect the public health.

(b)

Following each review under subsection (a), the Secretary shall publish in the Federal Register a list of food-borne contaminants that have the greatest adverse impact on public health. In determining whether a particular food-borne contaminant should be added to such list, the Secretary shall consider the number and severity of illnesses and the number of deaths associated with the foods associated with such contaminants.

(c)

In conjunction with the establishment of a performance standard under this section, the Secretary may make recommendations to industry for conducting product sampling.

(d)

All performance standards of the Food and Drug Administration applicable to foods or food classes in effect on the date of the enactment of this section, or issued under this section, shall remain in effect until revised or revoked by the Secretary.

(c)

The Secretary of Health and Human Services shall submit to the Congress by March 30th of the year following each review under section 419 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (b), a report on the results of such review and the Secretary’s plans to address the significant food-borne hazards identified, or the basis for not addressing any significant food-borne hazards identified, including any resource limitations or limitations in data that preclude further action at that time.

104.

(a)

Section 402 (21 U.S.C. 342), as amended by sections 102 and 103(a), is amended by adding at the end the following:

(m)

If it has been grown, harvested, processed, packed, sorted, transported, or held under conditions that do not meet the standards established under section 419A.

(b)

Chapter IV (21 U.S.C. 341 et seq.), as amended by sections 102(b) and 103(b), is amended by adding at the end the following:

419A.

(a)

The Secretary, in coordination with the Secretary of Agriculture, shall establish by regulation scientific and risk-based food safety standards for the growing, harvesting, processing, packing, sorting, transporting, and holding of those types of raw agricultural commodities—

(1)

that are a fruit, vegetable, nut, or fungus; and

(2)

for which the Secretary has determined that such standards are reasonably necessary to minimize the risk of serious adverse health consequences or death to humans or animals.

(b)

The regulations under subsection (a)—

(1)

may set forth such procedures, processes, and practices as the Secretary determines to be reasonably necessary—

(A)

to prevent the introduction of known or reasonably foreseeable biological, chemical, and physical hazards, including hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced, including by acts of terrorism, into raw agricultural commodities that are a fruit, vegetable, nut, or fungus; and

(B)

to provide reasonable assurances that such commodity is not adulterated under section 402;

(2)

may include, with respect to growing, harvesting, processing, packing, sorting, transporting, and storage operations, standards for safety as the Secretary determines to be reasonably necessary;

(3)

may include standards addressing manure use, water quality, employee hygiene, sanitation and animal control, and temperature controls, as the Secretary determines to be reasonably necessary;

(4)

may include standards for such other elements as the Secretary determines necessary to carry out subsection (a);

(5)

shall provide a reasonable period of time for compliance, taking into account the needs of small businesses for additional time to comply;

(6)

may provide for coordination of education and enforcement activities;

(7)

shall take into consideration, consistent with ensuring enforceable public health protection, the impact on small-scale and diversified farms, and on wildlife habitat, conservation practices, watershed-protection efforts, and organic production methods;

(8)

may provide for coordination of education and training with other government agencies, universities, private entities, and others with experience working directly with farmers; and

(9)

may provide for recognition through guidance of other existing publicly available procedures, processes, and practices that the Secretary determines to be equivalent to those established under paragraph (1).

(c)

The Secretary shall coordinate with the Secretary of Agriculture to provide for effective implementation of education and compliance activities. The Secretary may contract and coordinate with the agency or department designated by the Governor of each State to perform activities to ensure compliance with this section.

(c)

(1)

Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services shall issue a proposed rule to carry out section 419A of the Federal Food, Drug, and Cosmetic Act, as added by subsection (b).

(2)

Not later than 3 years after such date, the Secretary of Health and Human Services shall issue a final rule under such section.

(d)

(e)

Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall update the guidance document entitled Guidance For Industry: Guide To Minimize Microbial Food Safety Hazards For Fresh Fruits And Vegetables (issued on October 26, 1998) in accordance with this section and the amendments made by this section.

105.

(a)

Section 704 (21 U.S.C. 374) is amended by adding at the end the following:

(h)

(1)

Each facility registered under section 415 shall be inspected—

(A)

(i)

by one or more officers duly designated under section 702 or other statutory authority by the Secretary;

(ii)

for domestic facilities, by a Federal, State, or local official recognized by the Secretary under paragraph (2); or

(iii)

for foreign facilities, by an agency or a representative of a country that is recognized by the Secretary under paragraph (2); and

(B)

at a frequency determined pursuant to a risk-based schedule.

(2)

For purposes of paragraph (1)(A), the Secretary—

(A)

may recognize Federal, State, and local officials and agencies and representatives of foreign countries as meeting standards established by the Secretary for conducting inspections under this Act; and

(B)

may limit such recognition to inspections of specific commodities or food types.

(3)

The risk-based schedule under paragraph (1)(B) shall be implemented beginning not later than 18 months after the date of the enactment of this subsection.

(4)

Such risk-based schedule shall provide for a frequency of inspections commensurate with the risk presented by the facility and shall be based on the following categories and inspection frequencies:

(A)

A category 1 food facility is a high-risk facility that manufactures or processes food. The Secretary shall randomly inspect a category 1 food facility at least every 6 to 12 months.

(B)

A category 2 food facility is a low-risk facility that manufactures or processes food or a facility that packs or labels food. The Secretary shall randomly inspect a category 2 facility at least every 18 months to 3 years.

(C)

A category 3 food facility is a facility that holds food. The Secretary shall randomly inspect a category 3 facility at least every 5 years.

(5)

The Secretary—

(A)

may, by guidance, modify the types of food facilities within a category under paragraph (4);

(B)

may alter the inspection frequencies specified in paragraph (4) based on the need to respond to food-borne illness outbreaks and food recalls; and

(C)

may inspect a facility more frequently than the inspection frequency provided by paragraph (4);

(D)

beginning 6 months after submitting the report required by section 105(b)(2) of the Food Safety Enhancement Act of 2009, may—

(i)

publish in the Federal Register adjustments to the inspection frequencies specified in subparagraphs (B) and (C) of paragraph (4) for category 2 and category 3 food facilities, which adjustments shall be in accordance with the Secretary’s recommendations in such report; and

(ii)

after such publication, implement the adjustments; and

(E)

except as provided in subparagraphs (B) and (C), may not alter the inspection frequency specified in paragraph (4)(A) for category 1 food facilities.

(6)

In determining the appropriate frequency of inspection, the Secretary shall consider—

(A)

the type of food manufactured, processed, packed, or held at the facility;

(B)

the compliance history of the facility;

(C)

whether the facility importing or offering for import into the United States food is certified by a qualified certifying entity in accordance with section 801(q); and

(D)

such other factors as the Secretary determines by guidance to be relevant to assessing the risk presented by the facility.

(7)

Before establishing or modifying the categorization under paragraph (4) of any food facility or type of food facility, the Secretary shall publish a notice of the proposed categorization in the Federal Register and provide a period of not less than 60 days for public comment on the proposed categorization.

(b)

(1)

Not later than December 31 of each year, the Secretary of Health and Human Services shall submit a report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate describing—

(A)

the number of foreign and domestic facilities, by risk category, inspected under the risk-based inspection schedule established under section 704(h) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), in the preceding fiscal year; and

(B)

the costs of implementing the risk-based inspection schedule for the preceding 12 months.

(2)

Not later than 3 years after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit a report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate describing recommendations on the risk-based inspection schedule under section 704(h) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), including recommendations for adjustments to the timing of the schedule and other ways to improve the risk-based allocation of resources by the Food and Drug Administration. In making such recommendations, the Secretary shall consider—

(A)

the nature of the food products being processed, stored, or transported;

(B)

the manner in which food products are processed, stored, or transported;

(C)

the inherent likelihood that the products will contribute to the risk of food-borne illness;

(D)

the best available evidence concerning reported illnesses associated with the foods processed, stored, held, or transported in the category of facilities; and

(E)

the overall record of compliance with food safety law among facilities in the category, including compliance with applicable performance standards and the frequency of recalls.

106.

(a)

Subsection (a) of section 414 (21 U.S.C. 350c) is amended to read as follows:

(a)

(1)

(A)

Except as provided in paragraph (3), each person who manufactures, processes, packs, transports, distributes, receives, or holds an article of food in the United States or for import into the United States shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presentation of appropriate credentials, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records relating to such article bearing on whether the food may be adulterated, misbranded, or otherwise in violation of this Act, including all records collected or developed to comply with section 418 or 418A.

(B)

The requirement under subparagraph (A) applies to all records relating to the manufacture, processing, packing, transporting, distribution, receipt, holding, or importation of such article maintained by or on behalf of such person in any format (including paper and electronic formats) and at any location.

(C)

Records not required to be made available immediately on commencement of an inspection under subparagraph (A) shall nonetheless be made available immediately on commencement of such an inspection if, by a reasonable time before such inspection, the Secretary by letter to the person identifies the records to be made available during such inspection. Nothing in this subparagraph shall be construed as permitting a person to refuse to produce records required under and in accordance with subparagraph (A) due to failure of the Secretary to provide notice under this paragraph.

(2)

(A)

If the Secretary has a reasonable belief that an article of food presents a threat of serious adverse health consequences or death to humans or animals, the Secretary may require each person who manufactures, processes, packs, transports, distributes, receives, holds, or imports such article of food, or any article of food that the Secretary determines may be affected in a similar manner, to submit to the Secretary all records reasonably related to such article of food as soon as is reasonably practicable, after receiving written notice (including by notice served personally and outside normal business hours to an agent identified under subparagraph (E) or (F) of section 415(a)(2)) of such requirement.

(B)

With respect to a facility subject to section 418 and 418A, the Secretary may require the owner, operator, or agent of such facility to submit to the Secretary, as soon as reasonably practicable after receiving written notice of such requirement, the food safety plan, supporting information relied on by the facility to select the preventive controls to include in its food safety plan, and documentation of corrective actions, if any, taken under section 418(e) within the preceding 2 years

(C)

If the records required to be submitted to the Secretary under subparagraph (A) or (B) are available in electronic format, such records shall be submitted electronically unless the Secretary specifies otherwise in the notice under such subparagraph.

(3)

(A)

Paragraphs (1) and (2) do not apply with respect to farms, except as provided in this paragraph.

(B)

A person who is the owner, operator, or agent of a farm (as defined in section 415) shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records relating to an article of food produced, manufactured, processed, packed, or held on such farm as specified in paragraphs (1) and (2) if—

(i)

such article of food is a fruit, vegetable, nut, or fungus that is the subject of a standard issued under section 419A; or

(ii)

such article of food is the subject of an active investigation by the Secretary of a food borne illness outbreak and is not a grain or similarly handled commodity as defined in subsection (c)(4)(C)(ii).

(C)

(i)

As soon as practicable after the enactment of this paragraph, the Secretary shall, in coordination with the Secretary of Agriculture, identify 1 or more fruits, vegetables, nuts, or fungi for which the Secretary shall have access to records on farms. Such identification shall be made by guidance, following notice and public comment.

(ii)

The Secretary, in coordination with the Secretary of Agriculture, shall make the identification in clause (i), based on any past food borne illness outbreak attributed to the fruit, vegetable, nut, or fungus—

(I)

in the United States and the risk that a similar outbreak could occur again in the United States; or

(II)

in a foreign country and the risk that a similar outbreak could occur in the United States.

(iii)

The authority to have access to records for a fruit, vegetable, nut, or fungus under this subparagraph shall begin on the date on which the Secretary identifies such fruit, vegetable, nut, or fungus under clause (i) and shall terminate on the effective date of a final rule issued by the Secretary under section 419A.

(iv)

In the guidance under clause (i), and for the period specified in clause (iii), the Secretary, in coordination with the Secretary of Agriculture, shall determine the scope of the records to which the Secretary shall have access under this subparagraph.

(D)

This paragraph shall not be construed as limiting access to any records authorized under—

(i)

this Act or the Public Health Service Act, as in effect on the day before the date of the enactment of this paragraph; or

(ii)

regulations issued under such Acts on any date before the date of the enactment of this paragraph.

(b)

(1)

Subsection (b) of section 414 (21 U.S.C. 350c) is amended to read as follows:

(b)

The Secretary, in consultation and coordination, as appropriate, with other Federal departments and agencies with responsibilities for regulating food safety, shall by regulation establish requirements regarding the establishment and maintenance, for not longer than 3 years, of records by persons who manufacture, process, pack, transport, distribute, receive, or hold food in the United States or for import into the United States. The Secretary shall take into account the size of a business in promulgating regulations under this subsection. The Secretary shall consult with the Secretary of Agriculture in promulgating regulations with respect to farms under this subsection and shall take into account the nature of and impact on farms in promulgating such regulations. The only distribution records which may be required of restaurants under this subsection are those showing the restaurant’s suppliers and subsequent distribution other than to consumers.

(2)

The Secretary of Health and Human Services shall promulgate revised regulations to implement section 414(b) of the Federal Food, Drug, and Cosmetic Act, as amended by this subsection. Section 414(b) of the Federal Food, Drug, and Cosmetic Act and regulations thereunder, as in effect on the day before the date of the enactment of this Act, shall apply to acts and omissions occurring before the effective date of such revised regulations.

(c)

Section 704(a)(1) (21 U.S.C. 374(a)(1)) is amended—

(1)

in the second sentence—

(A)

by striking (excluding farms or restaurants) and inserting (excluding farms, except as provided in section 414(a)(3));

(B)

by inserting receives, before holds;

(C)

by striking described in section 414 and inserting described in or required under section 414; and

(D)

by striking when the Secretary has 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 and inserting bearing on whether such food is adulterated, misbranded, or otherwise in violation of this Act, including all records collected or developed to comply with section 418 or 418A; and

(2)

in the fourth sentence—

(A)

by striking the preceding sentence and inserting either of the preceding two sentences; and

(B)

by inserting recipes for food, before financial data,.

107.

(a)

Section 301(e) (21 U.S.C. 331(e)) is amended by inserting , the violation of any requirement of the food tracing system under section 414(c); before or the refusal to permit access to or verification or copying of any such required record.

(b)

Section 801(a) (21 U.S.C. 381(a)) is amended by inserting or (4) the requirements of section 414 have not been complied with regarding such article, before then such article shall be refused admission.

(c)

Section 414 (21 U.S.C. 350c), as amended by section 106, is amended—

(1)

by redesignating subsections (c) and (d) as subsections (d) and (e), respectively; and

(2)

by inserting after subsection (b) the following:

(c)

(1)

The Secretary shall by regulation establish a tracing system for food that is located in the United States or is for import into the United States.

(2)

(A)

Before issuing a proposed regulation under this subsection, the Secretary shall—

(i)

identify technologies and methodologies for tracing the distribution history of a food that are, or may be, used by members of different sectors of the food industry, including technologies and methodologies to enable each person who produces, manufactures, processes, pack, transports, or holds a food to—

(I)

maintain the full pedigree of the origin and previous distribution history of the food;

(II)

link that history with the subsequent distribution of the food;

(III)

establish and maintain a system for tracing the food that is interoperable with the systems established and maintained by other such persons; and

(IV)

use a unique identifier for each facility owned or operated by such person for such purpose, as specified under section 1011; and

(ii)

to the extent practicable, assess—

(I)

the costs and benefits associated with the adoption and use of such technologies;

(II)

the feasibility of such technologies for different sectors of the food industry; and

(III)

whether such technologies are compatible with the requirements of this subsection.

(B)

Before issuing a proposed regulation under this subsection, the Secretary shall conduct not less than 2 public meetings in diverse geographical areas of the United States to provide persons in different regions an opportunity to provide input and information to the Secretary.

(C)

Before issuing a proposed regulation under this subsection, the Secretary shall conduct 1 or more pilot projects in coordination with 1 or more sectors of the food industry to explore and evaluate tracing systems for food. The Secretary shall coordinate with the Secretary of Agriculture in conducting pilot projects with respect to farms under this subsection.

(3)

(A)

Taking into account information obtained through information gathering under paragraph (2), the Secretary shall issue regulations establishing a tracing system that enables the Secretary to identify each person who grows, produces, manufactures, processes, packs, transports, holds, or sells such food in as short a timeframe as practicable but no longer than 2 business days.

(B)

The Secretary may include in the regulations establishing a tracing system—

(i)

the establishment and maintenance of lot numbers;

(ii)

a standardized format for pedigree information; and

(iii)

the use of a common nomenclature for food.

(C)

In issuing regulations under this paragraph that will impact farms, the Secretary—

(i)

shall coordinate with the Secretary of Agriculture; and

(ii)

take into account the nature of the impact of the regulations on farms.

(4)

(A)

Food is exempt from the requirements of this subsection if such food is—

(i)

produced on a farm; and

(ii)

sold by the owner, operator, or agent in charge of such farm directly to a consumer or to a restaurant or grocery store.

(B)

Food is exempt from the requirements of this subsection if such food is produced through the use of a fishing vessel as defined in section 3(18) of the Magnuson-Stevens Fishery Conservation and Management Act until such time as the food is sold by the owner, operator, or agent in charge of such fishing vessel.

(C)

(i)

In addition to the exemption under subparagraph (A), any tracing system established under this subsection with regard to any grain or similarly handled commodity shall be limited to enabling the Secretary to identify persons who received, processed, packed, transported, distributed, held, or sold the grain or similarly handled commodity from the initial warehouse operator that held the grain or similarly handled commodity for any period of time to the ultimate consumer.

(ii)

In this subparagraph:

(I)

The term grain or similarly handled commodity means wheat, corn, grain sorghum, barley, oats, rice, wild rice, rye, soybeans, legumes, sugar cane, sugar beets, sunflower seed, rapeseed, canola, safflower, flaxseed, mustard seed, crambe, sesame seed, camelina, cottonseed, cocoa beans, grass hay, and honey. The term may include any other commodity as determined by the Secretary in coordination with the Secretary of Agriculture.

(II)

The term warehouse operator has the meaning given that term in section 2 of the United States Warehouse Act (7 U.S.C. 241), except that the term also includes any person or entity that handles or stores agricultural products for other persons or entities or, in the case of a cooperative, handles or stores agricultural products for its members, as determined by the Secretary in coordination with the Secretary of Agriculture.

(D)

The Secretary may by notice in the Federal Register exempt a food or a type of facility, farm, or restaurant from, or modify the requirements with respect to, the requirements of this subsection if the Secretary determines that a tracing system for such food or type of facility, farm, or restaurant is not necessary to protect the public health.

(E)

For a food or person covered by a limitation or exemption under subparagraph (B), (C), or (D), the Secretary shall require each person who produces, receives, manufactures, processes, packs, transports, distributes, or holds such food to maintain records to identify the immediate previous sources of such food and its ingredients and the immediate subsequent recipients of such food.

(F)

For a food covered by an exemption under subparagraph (A), restaurants and grocery stores shall keep records documenting the farm that was the source of the food.

(G)

For a food covered by an exemption under subparagraph (A), farms shall keep records, in electronic or non-electronic format, for at least 6 months documenting the restaurant or grocery store to which the food was sold.

108.

(a)

Part 6 of subchapter C of chapter VII (21 U.S.C. 371 et seq.), as added by section 101(c), is amended by adding at the end the following:

743A.

(a)

The Secretary shall assess and collect fees from each entity in a fiscal year—

(1)

that—

(A)

during such fiscal year commits a violation of any requirement of this Act relating to food, including any such requirement relating to good manufacturing practices; and

(B)

because of such violation, undergoes additional inspection by the Food and Drug Administration; or

(2)

during such fiscal year is subject to a food recall.

(b)

The Secretary shall set the amount of the fees under this section to fully cover the costs of—

(1)

in the case of fees collected under subsection (a)(1), conducting the additional inspections referred to in such subsection; and

(2)

in the case of fees collected under subsection (a)(2), conducting food recall activities, including technical assistance, follow-up effectiveness checks, and public notifications, during the fiscal year involved.

(c)

(1)

(2)

The fees authorized by this section—

(A)

shall be retained in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation, for such fiscal year; and

(B)

shall only be collected and available to defray the costs referred to in subsection (b).

(3)

For each of fiscal years 2010 through 2014, there are authorized to be appropriated for fees under this section such sums as may be necessary.

(d)

The Secretary shall waive and, if applicable, refund the amount of any fee collected under this section from an entity as a result of a food recall that the Secretary determines was inappropriately ordered.

(b)

The amendment made by subsection (a) shall apply to additional inspections and food recall activities occurring after the date of the enactment of this Act.

109.

(a)

(1)

Section 403 (21 U.S.C. 343), as amended by section 101(a), is amended by adding at the end the following:

(aa)

If it is part of a shipment offered for import into the United States and such shipment is in violation of section 801(q) (requiring a certification of compliance for certain food shipments).

(2)

The amendment made by paragraph (1) shall apply to shipments offered for import on or after the date that is 3 years after the date of the enactment of this Act.

(b)

Chapter VIII (21 U.S.C. 381 et seq.) is amended—

(1)

in section 801(a), as amended by section 107(b), by inserting after the third sentence the following: If such article is food being imported or offered for import into the United States and is not in compliance with the requirement of subsection (q) (relating to certifications of compliance with this Act), then such article shall be refused admission.;

(2)

in the second sentence of section 801(b), by striking the fourth sentence and inserting the fifth sentence; and

(3)

by adding at the end of section 801 the following:

(q)

(1)

(A)

The Secretary may require, as an additional condition of granting admission to an article of food being imported or offered for import into the United States, that a qualified certifying entity provide a certification that the article complies with requirements of this Act as specified by the Secretary if—

(i)

for food imported from a particular country, territory, or region, the Secretary finds, based on scientific, risk-based evidence, that the government controls in such country, territory, or region are inadequate to ensure that the article is safe and that certification would assist the Secretary in determining whether to refuse to admit such article under subsection (a);

(ii)

for a type of food for which there is scientific evidence that there is a particular risk associated with the food that presents a threat of serious adverse health consequences or death, the Secretary finds that certification would assist the Secretary in determining whether to refuse to admit such article under subsection (a); or

(iii)

for an article imported from a particular country or territory, there is an agreement between the Secretary and the government of such country or territory providing for such certification.

(B)

A certification under subparagraph (A) may take the form of a statement that the article or the facility or farm that manufactured, processed, packed, held, grew, harvested, sorted, or transported the article, as the case may be, complies with requirements of this Act as specified by the Secretary, or any other form as the Secretary may specify, including a listing of certified facilities or other entities. The Secretary may require that the certification include additional information regarding compliance.

(C)

(i)

Before requiring a certification under clause (ii) of subparagraph (A) with respect to a food, the Secretary shall establish a process by which a country or territory may demonstrate that its government controls are adequate to ensure that such food exported from its territory to the United States is safe.

(ii)

The Secretary shall not require a certification under clause (ii) of subparagraph (A) for a food exported from a country or territory, if that country or territory has demonstrated, pursuant to the process established by the Secretary under clause (i), that its government controls are adequate to ensure that such food exported from its territory to the United States is safe.

(D)

As a condition on acceptance of certifications from a qualified certifying entity, the Secretary shall require the qualified certifying entity to notify the Secretary whenever the qualified certifying entity cancels or suspends the certification of any facility or other entity included in a listing under subparagraph (B).

(E)

The Secretary shall apply this paragraph consistently with United States obligations under international agreements.

(2)

For purposes of this subsection, the term qualified certifying entity means—

(A)

an agency or a representative of the government of the country from which the article originated, as designated by such government or the Secretary; or

(B)

an individual or entity determined by the Secretary or an accredited body recognized by the Secretary to be qualified to provide a certification under paragraph (1).

(3)

(A)

The Secretary shall issue regulations to ensure that any qualified certifying entity and its auditors are free from conflicts of interest. In issuing these regulations, the Secretary may rely on or incorporate international certification standards.

(B)

Such regulations shall require that—

(i)

the qualified certifying entity shall have a committee or management structure for safeguarding impartiality;

(ii)

conflict of interest policies for a qualified certifying entity and auditors acting for the qualified certifying entity shall be written;

(iii)

the qualified certifying entity shall not be owned, operated, or controlled by a producer, manufacturer, processor, packer, holder, supplier, or vendor of any article of the type it certifies;

(iv)

the qualified certifying entity shall not have any ownership or financial interest in any product, producer, manufacturer, processor, packer, holder, supplier or vendor of the type it certifies;

(v)

no auditor acting for the qualified certifying entity (or spouse or minor children) shall have any significant ownership or other financial interest regarding any product of the type it certifies;

(vi)

the qualified certifying entity shall—

(I)

obtain and maintain annual declarations from all personnel who may be directly involved in the performance of audits as to whether they do or do not have direct financial interests in any producer, manufacturer, processor, packer, holder, supplier, or vendor of foods, and a list of any such companies in which they do have financial interests or by which they were employed in the past year; and

(II)

when an auditor is assigned to audit a facility, require that individual to affirm that he or she has no financial interest in the company that owns or operates that facility and was not employed by that facility in the previous year;

(vii)

neither the qualified certifying entity nor any of its auditors acting for the qualified certifying entity shall participate in the production, manufacture, processing, packing, holding, promotion, or sale of any product of the type it certifies;

(viii)

neither the qualified certifying entity nor any of its auditors shall provide consultative services to any facility certified by the qualified certifying entity, or the owner, operator, or agent in charge of such a facility, unless the qualified certifying entity has procedures in place, approved by the Secretary, to ensure separation of functions between auditors providing consultative services and auditors providing certification services under this subsection;

(ix)

no auditors acting for the qualified certifying entity shall participate in an audit of a facility they were employed by within the last 12 months;

(x)

fees charged or accepted shall not be contingent or based upon the report made by the qualified certifying entity or any personnel involved in the audit process;

(xi)

neither the qualified certifying entity nor any of its auditors shall accept anything of value from anyone in connection with the facility being audited other than the audit fee;

(xii)

the qualified certifying entity shall not be owned, operated, or controlled by a trade association whose member companies operate facilities that it certifies;

(xiii)

the qualified certifying entity and its auditors shall be free from any other conflicts of interest that threaten impartiality;

(xiv)

the qualified certifying entity and its auditors shall sign a statement attesting to compliance with the conflict of interests requirements under this paragraph; and

(xv)

the qualified certifying entity shall ensure that any subcontractors that might be used (such as laboratories and sampling services) provide similar assurances, except that it shall not be a violation of this subsection to the extent such subcontractors perform additional nutritional testing services unrelated to the testing under this subsection.

(C)

In this paragraph:

(i)

The term anything of value includes gifts, gratuities, reimbursement of non-audit-related expenses, entertainment, loans, or any other form of compensation in cash or in kind.

(ii)

The term direct financial interest does not include any ownership of mutual funds that have a financial interest in a company.

(4)

The Secretary shall—

(A)

require that, to the extent applicable, any certification provided by a qualified certifying entity be renewed by such entity at such times as the Secretary determines appropriate; and

(B)

refuse to accept any certification if the Secretary determines that such certification is no longer valid or reliable.

(5)

In evaluating whether an accreditation body meets, or continues to meet, the standards for recognition under this subsection, or whether to accept certifications from a qualified certifying entity, the Secretary may—

(A)

observe on-site audits of qualified certifying entities by such accreditation body; or

(B)

for any facility that is certified by a qualified certifying entity, upon request of an officer or employee designated by the Secretary and upon presentation of appropriate credentials, at reasonable times and within reasonable limits and in a reasonable manner, conduct an on-site audit of the facility, which shall include access to, and copying and verification of, any related records.

(6)

The Secretary shall provide, in coordination with the Commissioner responsible for Customs and Border Protection, for the electronic submission of certifications under this subsection.

(7)

This subsection shall not be construed to limit the authority of the Secretary to conduct random inspections of imported articles or facilities of importers, issue import alerts for detention without physical examination, require submission to the Secretary of documentation or other information about an article imported or offered for import, or to take such other steps as the Secretary deems appropriate to determine the admissibility of imported articles.

110.

(a)

Section 301 (21 U.S.C. 331) is amended by adding at the end the following:

(uu)

The violation of any requirement of section 714 (relating to testing by accredited laboratories).

(b)

Subchapter A of chapter VII (21 U.S.C. 371 et seq.) is amended by adding at the end the following:

714.

(a)

(1)

Whenever analytical testing of an article of food is conducted as part of testimony for the purposes of section 801(a), or for such other purposes as the Secretary deems appropriate through regulation or guidance, such testing shall be conducted by a laboratory that—

(A)

is accredited, for the analytical method used, by a laboratory accreditation body that has been recognized by the Secretary; and

(B)

samples such article with adequate controls for ensuring the integrity of the samples analyzed.

(2)

(A)

Tests required for purposes of section 801(a) or in response to a finding of noncompliance by the Secretary shall be conducted by a laboratory independent of the person on whose behalf such testing is conducted and analyzed.

(B)

The Secretary may require that testing for certain products under paragraph (1) be conducted by a laboratory independent of the person on whose behalf such testing is conducted.

(b)

The Secretary shall establish and implement a program for the recognition, based on standards the Secretary deems appropriate, of laboratory accreditation bodies that accredit laboratories to perform analytical testing for the purposes of this section. The Secretary shall issue regulations or guidance to implement this program.

(c)

In evaluating whether an accreditation body meets, or continues to meet, the standards for recognition under subsection (b), the Secretary may—

(1)

observe onsite audits of laboratories by such accreditation bodies; or

(2)

for any laboratory that is accredited by such accreditation body under this section, upon request of an officer or employee designated by the Secretary and upon presentation of appropriate credentials, at reasonable times and within reasonable limits and in a reasonable manner, conduct an onsite audit of the laboratory, which shall include access to, and copying and verification of, any related records.

(d)

The Secretary shall publish and maintain on the public Web site of the Food and Drug Administration a list of accreditation bodies recognized by the Secretary under subsection (b).

(e)

An accreditation body that has been recognized pursuant to this section shall promptly notify the Secretary whenever it accredits a laboratory for the purposes of this section and whenever it withdraws or suspends such accreditation.

(f)

Whenever analytical testing is conducted pursuant to subsection (a), the person on whose behalf the testing is conducted shall notify the Secretary before any sample of the article is collected. Such notice shall contain information the Secretary determines is appropriate to identify the article, the location of the article, and each laboratory that will analyze the sample on the person’s behalf.

(g)

Whenever analytical testing is conducted pursuant to subsection (a), the laboratory conducting such testing shall submit, directly to the Secretary—

(1)

the results of all analyses conducted by the laboratory on each sample of such article; and

(2)

all information the Secretary deems appropriate to—

(A)

determine whether the laboratory is accredited by a recognized laboratory accreditation body;

(B)

identify the article tested;

(C)

evaluate the analytical results; and

(D)

determine whether the requirements of this section have been met.

(h)

The Secretary may waive the requirement of subsection (a)(1)(A) (relating to analytical methods) on a laboratory or method basis due to exigent or other circumstances.

(i)

If Customs and Border Protection laboratory testing concludes that an article of food is adulterated or misbranded, the Secretary shall consider and utilize as appropriate the testing results issued by the Customs and Border Protection laboratories in making a decision about the admissibility of the product.

(j)

Nothing in this section shall be construed to limit—

(1)

the ability of the Secretary to review and act upon information from the analytical testing of food (including under this section), including determining the sufficiency of such information and testing; or

(2)

the authority of the Secretary to conduct, require, or consider the results of analytical testing pursuant to any other provision of law.

111.

(a)

Section 301 (21 U.S.C. 331), as amended by section 110, is amended by adding at the end the following:

(vv)

(1)

The failure to notify the Secretary in violation of section 420(a).

(2)

The failure to comply with any order issued under section 420.

(b)

Chapter IV (21 U.S.C. 341 et seq.), as amended by sections 102, 103, and 104, is amended by adding at the end the following:

420.

(a)

(1)

A responsible party as that term is defined in section 417(a)(1) or a person required to register under section 801(s) that has reason to believe that an article of food when introduced into or while in interstate commerce, or while held for sale (regardless of whether the first sale) after shipment in interstate commerce, is adulterated or misbranded in a manner that presents a reasonable probability that the use or consumption of, or exposure to, the article (or an ingredient or component used in any such article) will cause a threat of serious adverse health consequences or death to humans or animals shall, as soon as practicable, notify the Secretary of the identity and location of the article.

(2)

Notification under paragraph (1) shall be made in such manner and by such means as the Secretary may require by regulation or guidance.

(b)

The Secretary may request that any person who distributes an article of food that the Secretary has reason to believe is adulterated, misbranded, or otherwise in violation of this Act voluntarily—

(1)

recall such article; and

(2)

provide for notice, including to individuals as appropriate, to persons who may be affected by the recall.

(c)

If the Secretary has reason to believe that the use or consumption of, or exposure to, an article of food may cause serious adverse health consequences or death to humans or animals, the Secretary shall have the authority to issue an order requiring any person who distributes such article to immediately cease distribution of such article.

(d)

Any person who is subject to an order under subsection (c) shall immediately cease distribution of such article and provide notification as required by such order, and may appeal within 24 hours of issuance such order to the Secretary. Such appeal may include a request for an informal hearing and a description of any efforts to recall such article undertaken voluntarily by the person, including after a request under subsection (b). Except as provided in subsection (f), an informal hearing shall be held as soon as practicable, but not later than 5 calendar days, or less as determined by the Secretary, after such an appeal is filed, unless the parties jointly agree to an extension. After affording an opportunity for an informal hearing, the Secretary shall determine whether the order should be amended to require a recall of such article. If, after providing an opportunity for such a hearing, the Secretary determines that inadequate grounds exist to support the actions required by the order, the Secretary shall vacate the order.

(e)

(1)

Except as provided under subsection (f), if after providing an opportunity for an informal hearing under subsection (d), the Secretary determines that the order should be amended to include a recall of the article with respect to which the order was issued, the Secretary shall amend the order to require a recall.

(2)

An amended order under paragraph (1) shall—

(A)

specify a timetable in which the recall will occur;

(B)

require periodic reports to the Secretary describing the progress of the recall; and

(C)

provide for notice, including to individuals as appropriate, to persons who may be affected by the recall.

In providing for such notice, the Secretary may allow for the assistance of health professionals, State or local officials, or other individuals designated by the Secretary.

(3)

An amended order under this subsection shall be ordered by the Secretary or an official designated by the Secretary. An official may not be so designated unless the official is the director of the district under this Act in which the article involved is located, or is an official senior to such director.

(f)

(1)

If the Secretary has credible evidence or information that an article of food subject to an order under subsection (c) presents an imminent threat of serious adverse health consequences or death to humans or animals, the Secretary may issue an order requiring any person who distributes such article—

(A)

to immediately recall such article; and

(B)

to provide for notice, including to individuals as appropriate, to persons who may be affected by the recall.

(2)

Any person who is subject to an emergency recall order under this subsection shall immediately recall such article and provide notification as required by such order, and may appeal within 24 hours after issuance such order to the Secretary. An informal hearing shall be held within as soon as practicable but not later than 5 calendar days, or less as determined by the Secretary, after such an appeal is filed, unless the parties jointly agree to an extension. After affording an opportunity for an informal hearing, the Secretary shall determine whether the order should be amended pursuant to subsection (e)(1). If, after providing an opportunity for such a hearing, the Secretary determines that inadequate grounds exist to support the actions required by the order, the Secretary shall vacate the order.

(3)

An order under this subsection shall be issued by the Commissioner of Food and Drugs, the Principal Deputy Commissioner, or the Associate Commissioner for Regulatory Affairs of the Food and Drug Administration.

(g)

The Secretary shall, as the Secretary determines to be necessary, provide notice of a recall order under this section to consumers to whom the article was, or may have been, distributed and to appropriate State and local health officials.

(h)

Nothing contained in this section shall be construed as limiting—

(1)

the authority of the Secretary to issue an order to cease distribution of, or to recall, an article under any other provision of this Act or the Public Health Service Act; or

(2)

the ability of the Secretary to request any person to perform a voluntary activity related to any article subject to this Act or the Public Health Service Act.

(c)

The third sentence of subsection (a) of section 801 (21 U.S.C. 381), as amended by section 107(b), is amended by inserting or (5) such article is subject to an order under section 420 to cease distribution of or recall the article, before then such article shall be refused admission.

(d)

Sections 301(vv)(1) and 420 of the Federal Food, Drug, and Cosmetic Act, as added by subsections (a) and (b), shall apply with respect to articles of food as of such date, not later than 1 year after the date of the enactment of this Act, as the Secretary of Health and Human Services shall specify.

112.

(a)

Section 417 (21 U.S.C. 350f) is amended—

(1)

in subsection (a)(1), by striking means a person and all that follows through the end of paragraph (1) and inserting the following:

means—

(A)

a person who submits the registration under section 415(a) for a food facility that is required to be registered under section 415(a), at which such food is manufactured, processed, packed, or held;

(B)

a person who owns, operates, is an agent of, or is otherwise responsible for such food on a farm (as such term is defined in section 1.227(b)(3) of title 21, Code of Federal Regulations, or successor regulations) at which such food is produced for sale or distribution in interstate commerce;

(C)

a person who owns, operates, or is an agent of a restaurant or other retail food establishment (as such terms are defined in section 1.227(b)(11) and (12), respectively, of title 21, Code of Federal Regulations, or successor regulations) at which such food is offered for sale; or

(D)

a person that is required to register pursuant to section 801(s) with respect to importation of such food.

;

(2)

in subsection (b), by adding at the end the following:

(3)

In addition to the electronic portal described in paragraph (1), the Secretary shall make available alternative means of reporting under this section with respect to farms, restaurants, and other retail food establishments with limited ability for such reporting.

;

(3)

in subsection (d)(1)—

(A)

in the matter preceding subparagraph (A), by inserting following a timely review of any reasonably available data and information, after reportable food,;

(B)

in subparagraph (A), by striking and at the end;

(C)

by redesignating subparagraph (B) as subparagraph (C); and

(D)

by inserting after subparagraph (A) the following:

(B)

submit, with such report, through the electronic portal, documentation of results from any sampling and testing of such article, including—

(i)

analytical results from testing of such article conducted by or on behalf of the responsible party under section 418, 418A, 419, 419A, or 714;

(ii)

analytical results from testing conducted by or on behalf of such responsible party of a component of such article;

(iii)

analytical results of environmental testing of any facility at which such article, or a component of such article, is manufactured, processed, packed, or held; and

(iv)

any other information the Secretary determines is necessary to evaluate the adulteration of such article, any component of such article, any other article of food manufactured, processed, packed or held in the same manner as, or at the same facility as, such article, or any other article containing a component from the same source as a component of such article; and

; and

(4)

in subsection (e)—

(A)

in paragraph (1), by inserting if the responsible party is required to register after 415(a)(3); and

(B)

by adding at the end the following:

(12)

Such additional information as the Secretary deems appropriate.

(b)

Section 708 (21 U.S.C. 379) is amended—

(1)

by striking The Secretary and inserting (a) The Secretary; and

(2)

by adding at the end the following:

(b)

(1)

(A)

The Secretary may provide to any Federal agency acting within the scope of its jurisdiction any information relating to food that is exempt from disclosure pursuant to subsection (a) of section 552 of title 5, United States Code, by reason of subsection (b)(4) of such section, or that is referred to in section 301(j) or 415(a)(4).

(B)

Any such information provided to another Federal agency shall not be disclosed by such agency except in any action or proceeding under the laws of the United States to which the receiving agency or the United States is a party.

(2)

(A)

In carrying out this Act, the Secretary may provide to a State or local government agency any information relating to food that is exempt from disclosure pursuant to section 552(a) of title 5, United States Code, by reason of subsection (b)(4) of such section, or that is referred to in section 301(j) or 415(a)(4).

(B)

Any such information provided to a State or local government agency shall not be disclosed by such agency.

(3)

In carrying out this Act, the Secretary may provide to any person any information relating to food that is exempt from disclosure pursuant to section 552(a) of title 5, United States Code, by reason of subsection (b)(4) of such section, if the Secretary determines that providing the information to the person is appropriate under the circumstances and the recipient provides adequate assurances to the Secretary that the recipient will preserve the confidentiality of the information.

(4)

In carrying out this Act, the Secretary may provide any information relating to food that is exempt from disclosure pursuant to section 552(a) of title 5, United States Code, by reason of subsection (b)(4) of such section, or that is referred to in section 301(j)—

(A)

to any foreign government agency; or

(B)

any international organization established by law, treaty, or other governmental action and having responsibility—

(i)

to facilitate global or regional harmonization of standards and requirements in an area of responsibility of the Food and Drug Administration; or

(ii)

to promote and coordinate public health efforts,

if the agency or organization provides adequate assurances to the Secretary that the agency or organization will preserve the confidentiality of the information.

(c)

Except where specifically prohibited by statute, the Secretary may disclose to the public any information relating to food that is exempt from disclosure pursuant to section 552(a) of title 5, United States Code, by reason of subsection (b)(4) of such section, if the Secretary determines that such disclosure is necessary to protect the public health.

(d)

Except as provided in subsection (e), the Secretary shall not be required to disclose under section 552 of title 5, United States Code, or any other provision of law any information relating to food obtained from a Federal, State, or local government agency, or from a foreign government agency, or from an international organization described in subsection (b)(4), if the agency or organization has requested that the information be kept confidential, or has precluded such disclosure under other use limitations, as a condition of providing the information.

(e)

Nothing in subsection (d) authorizes the Secretary to withhold information from the Congress or prevents the Secretary from complying with an order of a court of the United States.

(f)

This section shall not affect the authority of the Secretary to provide or disclose information under any other provision of law.

(c)

Section 301(j) (21 U.S.C. 331(j)) is amended by striking or to the courts when relevant in any judicial proceeding under this Act, and inserting to the courts when relevant in any judicial proceeding under this Act, or as specified in section 708,.

113.

Chapter VIII (21 U.S.C. 381 et seq.) is amended by adding at the end the following:

805.

(a)

The Secretary may establish by regulation or guidance in coordination with the Commissioner responsible for Customs and Border Protection a program that facilitates the movement of food through the importation process under this Act if the importer of such food—

(1)

verifies that each facility involved in the production, manufacture, processing, packaging, and holding of the food is in compliance with the food safety and security guidelines developed under subsection (b) with respect to such food;

(2)

ensures that appropriate safety and security controls are in place throughout the supply chain for such food; and

(3)

provides supporting information to the Secretary.

(b)

(1)

For purposes of the program established under subsection (a), the Secretary shall develop in consultation with the Commissioner responsible for Customs and Border Protection safety and security guidelines applicable to the importation of food taking into account, to the extent appropriate, other relevant Federal programs, such as the Customs-Trade Partnership Against Terrorism (C-TPAT) programs under section 211 of the Security and Accountability for Every Port Act of 2006.

(2)

Such guidelines shall take into account the following factors:

(A)

The personnel of the person importing the food.

(B)

The physical and procedural safety and security of such person’s food supply chain.

(C)

The sufficiency of preventive controls for food and ingredients purchased by such person.

(D)

Vendor and supplier information.

(E)

Other programs for certification or verification by a qualified certifying entity used by the importer.

(F)

Such other factors as the Secretary determines necessary.

114.

(a)

Section 403 (21 U.S.C. 343), as amended by sections 101(a) and 109(a), is amended by adding at the end the following:

(bb)

If it is a new infant formula and—

(1)

it is not the subject of a registration made pursuant to section 412(c)(1)(A);

(2)

it is not the subject of a submission made pursuant to section 412(c)(1)(B), or

(3)

at least 90 days have not passed since the making of such registration or of such submission to the Secretary.

(b)

Section 412 (21 U.S.C. 350a) is amended—

(1)

in subsection (c)(1)(B), by striking (c)(1) at the end and inserting (d)(1), subject to subsection (d)(2)(B);

(2)

in subsection (d)(1)—

(A)

by striking and at the end of subparagraph (C);

(B)

by striking the period at the end of subparagraph (D) and inserting , and; and

(C)

by adding at the end the following:

(E)

information on any new ingredient in accordance with paragraph (2)(A).

;

(3)

in subsection (d), by redesignating paragraphs (2) and (3) as paragraphs (3) and (4), respectively; and

(4)

by inserting after paragraph (1) of subsection (d) the following:

(2)

(A)

The description of any new infant formula required under paragraph (1) shall include, for any new ingredient for use in the formula—

(i)

a citation to a prior approval by the Secretary of the new ingredient for use in infant formula under section 409;

(ii)

a citation to or information showing a prior consideration of the new ingredient for use in infant formula under any program established by the Secretary for the review of ingredients used in food; or

(iii)

for a new ingredient that is not a food additive or a color additive, information equivalent to that provided under any program established by the Secretary for the review of ingredients used in food.

(B)

If the information submitted under subparagraph (A) is the information described in clause (iii) of such subparagraph, the 90 day period provided by subsection (c)(1)(B) shall not commence until the Secretary has completed review of the information submitted under such clause and has provided the submitter notice of the results of such review.

121.

(a)

In this section, the term food-borne illness outbreak means the occurrence of 2 or more cases of a similar illness resulting from the ingestion of a food.

(b)

The Secretary of Health and Human Services (in this subtitle referred to as the Secretary), acting through the Director of the Centers for Disease Control and Prevention, shall enhance food-borne illness surveillance systems to improve the collection, analysis, reporting, and usefulness of data on food-borne illnesses by—

(1)

coordinating Federal, State, and local food-borne illness surveillance systems, including complaint systems, and increasing participation in national networks of public health and food regulatory agencies and laboratories;

(2)

facilitating sharing of findings on a more timely basis among governmental agencies, including the Food and Drug Administration, the Department of Agriculture, and State and local agencies, and with the public;

(3)

developing improved epidemiological tools for obtaining quality exposure data, and microbiological methods for classifying cases;

(4)

augmenting such systems to improve attribution of a food-borne illness outbreak to a specific food;

(5)

expanding capacity of such systems, including fingerprinting and other detection strategies for food-borne infectious agents, in order to identify new or rarely documented causes of food-borne illness;

(6)

allowing timely public access to aggregated, de-identified surveillance data;

(7)

at least annually, publishing current reports on findings from such systems;

(8)

establishing a flexible mechanism for rapidly initiating scientific research by academic institutions;

(9)

integrating food-borne illness surveillance systems and data with other biosurveillance and public health situational awareness capabilities at the Federal, State, and local levels; and

(10)

other activities as determined appropriate by the Secretary.

(c)

(1)

The Secretary shall develop and implement strategies to leverage and enhance the food safety and defense capacities of State and local agencies in order to achieve the following goals:

(A)

Improve food-borne illness outbreak response and containment.

(B)

Accelerate food-borne illness surveillance and outbreak investigation, including rapid shipment of clinical isolates from clinical laboratories to appropriate State laboratories, and conducting more standardized illness outbreak interviews.

(C)

Strengthen the capacity of State and local agencies to carry out inspections and enforce safety standards.

(D)

Improve the effectiveness of Federal, State, and local partnerships to coordinate food safety and defense resources and reduce the incidence of food-borne illness.

(E)

Share information on a timely basis among public health and food regulatory agencies, with the food industry, with health care providers, and with the public.

(2)

In developing the strategies required by paragraph (1), the Secretary shall, not later than 1 year after the date of enactment of this Act, complete a review of State and local capacities, and needs for enhancement, which may include a survey with respect to—

(A)

staffing levels and expertise available to perform food safety and defense functions;

(B)

laboratory capacity to support surveillance, outbreak response, inspection, and enforcement activities;

(C)

information systems to support data management and sharing of food safety and defense information among State and local agencies and with counterparts at the Federal level; and

(D)

other State and local activities and needs as determined appropriate by the Secretary.

122.

(a)

The Secretary, in cooperation with private and public organizations, including the appropriate State entities, shall design and implement a national public education program on food safety. The program shall provide—

(1)

information to the public so that individuals can understand the potential impact and risk of food-borne illness, take action to reduce their risk of food-borne illness and injury, and make healthy dietary choices;

(2)

information to health professionals so that they may improve diagnosis and treatment of food-related illness and advise individuals whose health conditions place them in particular risk; and

(3)

such other information or advice to consumers and other persons as the Secretary determines will promote the purposes of this Act.

(b)

The Secretary shall work with the States and other appropriate entities to—

(1)

develop and distribute regional and national advisories concerning food safety;

(2)

develop standardized formats for written and broadcast advisories; and

(3)

incorporate State and local advisories into the national public education program required under subsection (a).

123.

The Secretary shall conduct research to assist in the implementation of this Act, including studies to—

(1)

improve sanitation and food safety practices in the production, harvesting, and processing of food products;

(2)

develop improved techniques for the monitoring of food and inspection of food products;

(3)

develop efficient, rapid, and sensitive methods for determining and detecting the presence of contaminants in food products;

(4)

determine the sources of contamination of food and food products, including critical points of risk for fresh produce and other raw agricultural commodities;

(5)

develop consumption data with respect to food products;

(6)

draw upon research and educational programs that exist at the State and local level;

(7)

utilize the DNA matching system and other processes to identify and control pathogens;

(8)

address common and emerging zoonotic diseases;

(9)

develop methods to reduce or destroy pathogens before, during, and after processing;

(10)

analyze the incidence of antibiotic resistance as it pertains to the food supply and evaluate methods to reduce the transfer of antibiotic resistance to humans; and

(11)

conduct other research that supports the purposes of this Act.

131.

Section 304(b) (21 U.S.C. 334(b)) is amended by inserting and except that, with respect to proceedings relating to food, Rule G of the Supplemental Rules of Admiralty or Maritime Claims and Asset Forfeiture Actions shall not apply in any such case, exigent circumstances shall be deemed to exist for all seizures brought under this section, and the summons and arrest warrant shall be issued by the clerk of the court without court review in any such case after in any such case shall be tried by jury.

132.

(a)

Section 304(h) (21 U.S.C. 334(h)) is amended—

(1)

in paragraph (1)(A), by striking credible evidence or information indicating and inserting reason to believe;

(2)

in paragraph (1)(A), by striking presents a threat of serious adverse health consequences or death to humans or animals and inserting is adulterated, misbranded, or otherwise in violation of this Act;

(3)

in paragraph (2), by striking 30 and inserting 60;

(4)

in paragraph (3), by striking the third sentence; and

(5)

in paragraph (4)(A) by striking the terms five and five-day and inserting fifteen and fifteen-day, respectively.

(b)

The Secretary shall issue regulations or guidance to implement the amendments made by this section.

(c)

The amendments made by this section shall take effect 180 days after the date of the enactment of this Act.

133.

(a)

Section 301 (21 U.S.C. 331), as amended by sections 110 and 111, is amended by adding at the end by adding the following:

(ww)

The violation of a prohibition or restriction under section 304(i).

(b)

Section 304 (21 U.S.C. 334) is amended by adding at the end the following:

(i)

(1)

(A)

(i)

After consultation with the Governor or other appropriate official of an affected State, if the Secretary determines that there is credible evidence that an article of food presents an imminent threat of serious adverse health consequences or death to humans or animals, the Secretary may prohibit or restrict the movement of an article of food within a State or portion of a State for which the Secretary has credible evidence that such food is located within, or originated from, such State or portion thereof.

(ii)

In carrying out clause (i), the Secretary may prohibit or restrict the movement within a State or portion of a State of any article of food or means of conveyance of such article of food, if the Secretary determines that the prohibition or restriction is a necessary protection from an imminent threat of serious adverse health consequences or death to humans or animals.

(2)

Subject to paragraph (3), before any action is taken in a State under this subsection, the Secretary shall—

(A)

notify the Governor or other appropriate official of the State affected by the proposed action;

(B)

issue a public announcement of the proposed action; and

(C)

publish in the Federal Register—

(i)

the findings of the Secretary that support the proposed action;

(ii)

a statement of the reasons for the proposed action; and

(iii)

a description of the proposed action, including—

(I)

the area affected; and

(II)

an estimate of the anticipated duration of the action.

(3)

If it is not practicable to publish in the Federal Register the information required under paragraph (2)(C) before taking action under paragraph (1), the Secretary shall publish the information as soon as practicable, but not later than 10 business days, after commencement of the action.

(4)

No action shall be taken under paragraph (1) unless, in the opinion of the Secretary, there is no less drastic action that is feasible and that would be adequate to prevent the imminent threat of serious adverse health consequences or death to humans or animals.

(5)

An action under paragraph (1) may only be ordered by the Secretary or an official designated by the Secretary. An official may not be so designated unless the official is the Commissioner of Food and Drugs or the Principal Deputy Commissioner.

(6)

Fourteen days after the initiation of an action under paragraph (1), and each 14 days thereafter, if the Secretary determines that it is necessary to continue the action, the Secretary shall—

(A)

notify the Governor or other appropriate official of the State affected of the continuation of the action;

(B)

issue a public announcement of the continuation of the action; and

(C)

publish in the Federal Register the findings of the Secretary that support the continuation of the action, including an estimate of the anticipated duration of the action.

(7)

The Secretary shall, consistent with national security interests and as appropriate for known hazards, establish by regulation standards for conducting actions under paragraph (1), including, as appropriate, sanitation standards and procedures to restore any affected equipment or means of conveyance to its status prior to an action under paragraph (1).

134.

Section 303(a) (21 U.S.C. 333) is amended—

(1)

in paragraph (1), by striking Any and inserting Except as provided in paragraph (2) or (3), any; and

(2)

by adding at the end the following:

(3)

Notwithstanding paragraph (1), any person who knowingly violates paragraph (a), (b), (c), (k), or (v) of section 301 with respect to any food that is misbranded or adulterated shall be imprisoned for not more than 10 years or fined in accordance with title 18, United States Code, or both.

135.

(a)

Paragraph (2) of section 303(f) (21 U.S.C. 331 et seq.) is amended to read as follows:

(2)

(A)

Any person who violates a provision of section 301 relating to food shall be subject to a civil penalty for each such violation of not more than—

(i)

$20,000 in the case of an individual, not to exceed $50,000 in a single proceeding; and

(ii)

$250,000 in the case of any other person, not to exceed $1,000,000 in a single proceeding.

(B)

Any person who knowingly violates a provision of section 301 relating to food shall be subject to a civil penalty for each such violation of not more than—

(i)

$50,000 in the case of an individual, not to exceed $100,000 in a single proceeding; and

(ii)

$500,000 in the case of any other person, not to exceed $7,500,000 in a single proceeding.

(C)

Each violation described in subparagraph (A) or (B) and each day during which the violation continues shall be considered to be a separate offense.

(b)

The amendment made by subsection (a) applies to violations committed on or after the date of the enactment of this Act.

136.

(a)

Section 301 (21 U.S.C. 331), as amended by sections 110, 111, and 133, is amended by adding at the end the following:

(xx)

The submission of information relating to food that is required by or under section 801 that is inaccurate or incomplete.

(yy)

The failure to submit information relating to food that is required by or under section 801.

(b)

Section 801 (21 U.S.C. 381), as amended by section 109, is amended by adding at the end the following:

(r)

(1)

The Secretary may require by regulation or guidance the submission of documentation or other information for articles of food that are imported or offered for import into the United States. When developing any regulation or guidance in accordance with this paragraph, to the extent that the collection of documentation or other information involves Customs and Border Protection efforts or resources, the Secretary shall consult with Customs and Border Protection.

(2)

A regulation or guidance under paragraph (1) may specify the format for submission of the documentation or other information.

201.

Section 409 (21 U.S.C. 348) is amended by adding at the end the following:

(k)

(1)

Not later than 60 days after the date of receipt by the Secretary, after the date of the enactment of this subsection, of a determination that a substance is a GRAS food substance, the Secretary shall post notice of such determination and the supporting scientific justifications on the Food and Drug Administration’s public Web site.

(2)

Not later than 60 days after the date of receipt of a request under paragraph (1), the Secretary shall acknowledge receipt of such request by informing the requester in writing of the date on which the request was received.

(3)

In this subsection, the term GRAS food substance means a substance excluded from the definition of the term food additive in section 201(s) because such substance is generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use.

202.

(a)

Section 403 (21 U.S.C. 343), as amended by sections 101(a), 109(a), and 114(a), is amended by adding at the end the following:

(cc)

In the case of a processed food, if the labeling of the food fails to identify the country in which the final processing of the food occurs.

(dd)

In the case of nonprocessed food, if the labeling of the food fails to identify the country of origin of the food.

(b)

(1)

Not later than 180 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall promulgate final regulations to carry out paragraphs (cc) and (dd) of section 403 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a).

(2)

Regulations promulgated under paragraph (1) shall provide that labeling meets the requirements of paragraphs (cc) and (dd) of section 403 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), if—

(A)

in the case of a processed food, the label of the food informs the consumer of the country where the final processing of the food occurred in accordance with country of origin marking requirements of the United States Customs and Border Protection; or

(B)

in the case of a nonprocessed food, the label of the food informs the consumer of the country of origin of the food in accordance with labeling requirements of the Department of Agriculture.

(c)

The requirements of paragraphs (cc) and (dd) of section 403 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), take effect on the date that is 2 years after the date of the enactment of this Act.

203.

Section 801(e)(4) (21 U.S.C. 381) is amended—

(1)

in the matter preceding clause (i) in subparagraph (A)—

(A)

by inserting from the United States after exports; and

(B)

by striking a drug, animal drug, or device and inserting a food (including animal feed), drug, animal drug, or device;

(2)

in subparagraph (A)(i)—

(A)

by striking in writing; and

(B)

by striking exported drug, animal drug, or device and inserting exported food, drug, animal drug, or device;

(3)

in subparagraph (A)(ii)—

(A)

by striking in writing;

(B)

by striking the drug, animal drug, or device and inserting the food, drug, animal drug, or device; and

(C)

by striking the drug or device and inserting the food, drug, or device;

(4)

by redesignating subparagraph (B) as subparagraph (C);

(5)

by inserting after subparagraph (A) the following:

(B)

For purposes of this paragraph, a certification by the Secretary shall be made on such basis and in such form (such as a publicly available listing) as the Secretary determines appropriate.

; and

(6)

by adding at the end the following:

(D)

Notwithstanding subparagraph (C), if the Secretary issues an export certification within the 20 days prescribed by subparagraph (A) with respect to the export of food, a fee for such certification shall not exceed such amount as the Secretary determines is reasonably related to the cost of issuing certificates under subparagraph (A) with respect to the export of food. The Secretary may adjust this fee annually to account for inflation and other cost adjustments. Fees collected for a fiscal year pursuant to this subparagraph shall be credited to the appropriation account for salaries and expenses of the Food and Drug Administration and shall be available in accordance with appropriations Acts until expended, without fiscal year limitation. Such fees shall be collected in each fiscal year in an amount equal to the amount specified in appropriations Acts for such fiscal year and shall only be collected and available for the costs of the Food and Drug Administration to cover the cost of issuing such certifications. Such sums as necessary may be transferred from such appropriation account for salaries and expenses of the Food and Drug Administration without fiscal year limitation to such appropriation account for salaries and expenses with fiscal year limitation.

204.

(a)

(1)

Section 301 (21 U.S.C. 331), as amended by sections 110, 111, 133, and 136, is amended by adding at the end the following:

(zz)

The failure to register in accordance with section 801(s).

(2)

Section 403 (21 U.S.C. 343) as amended by sections 101(a), 109(a), 114(a), and 202, is amended by adding at the end the following:

(ee)

If it is imported or offered for import by an importer not duly registered under section 801(s).

(3)

Section 801, as amended by sections 109 and 136, is amended by adding at the end the following:

(s)

(1)

The Secretary shall require an importer of food—

(A)

to be registered with the Secretary in a form and manner specified by the Secretary; and

(B)

consistent with section 1011, to submit appropriate unique facility identifiers as a condition of registration.

(2)

The maintenance of registration under this subsection is conditioned on compliance with good importer practices in accordance with the following:

(A)

The Secretary, in consultation with Customs and Border Protection, shall promulgate regulations to establish good importer practices that specify the measures an importer shall take to ensure imported food is in compliance with the requirements of this Act.

(B)

The measures under subparagraph (A) shall ensure that the importer of a food—

(i)

has adequate information about the food, its hazards, and the requirements of this Act applicable to such food;

(ii)

has adequate information or procedures in place to verify that both the food and each person that produced, manufactured, processed, packed, transported, or held the food, including components of the food, are in compliance with the requirements of this Act; and

(iii)

has adequate procedures in place to take corrective action, such as the ability to appropriately trace, withhold, and recall articles of food, if a food imported by the importer is not in compliance with the requirements of this Act.

(C)

In promulgating good importer practices regulations, the Secretary may, as appropriate—

(i)

incorporate certification of compliance under section 801(q) and participation in the safe and secure food importation program under section 805; and

(ii)

take into account differences among importers and the types of imports, including based on the level of risk posed by the imported food.

(3)

(A)

Registration under this subsection is subject to suspension upon a finding by the Secretary, after notice and an opportunity for an informal hearing, of—

(i)

a violation of this Act; or

(ii)

the knowing or repeated making of an inaccurate or incomplete statement or submission of information relating to the importation of food.

(B)

The importer whose registration is suspended may request that the Secretary vacate the suspension of registration when such importer has corrected the violation that is the basis for such suspension.

(C)

If the Secretary determines that adequate reasons do not exist to continue the suspension of a registration, the Secretary shall vacate such suspension.

(4)

(A)

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)

Cancellation shall be preceded by notice to the importer of the intent to cancel the registration and the basis for such cancellation.

(C)

If the registration for the importer is updated or corrected no later than 7 days after notice is provided under subparagraph (B), the Secretary shall not cancel such registration.

(5)

The Secretary, by notice published in the Federal Register—

(A)

shall establish an exemption from the requirements of this subsection for importations for personal use; and

(B)

may establish other exemptions from the requirements of this subsection.

(4)

Not later than 36 months after the date of the enactment of this Act, the Secretary of Health and Human Services in consultation with the Commissioner responsible for Customs and Border Protection shall promulgate the regulations required to carry out section 801(s) of the Federal Food, Drug, and Cosmetic Act, as added by paragraph (3). In establishing the effective date of a regulation promulgated under section 801(s), the Secretary shall, in consultation with the Commissioner responsible for Customs and Border Protection, as appropriate, provide a reasonable period of time for importers of food to comply with good importer practices, taking into account differences among importers and the types of imports, including based on the level of risk posed by the imported food.

(5)

The amendments made by this subsection shall take effect on the date that is 24 months after the date of enactment of this Act.

(b)

Subchapter C of chapter VII (21 U.S.C. 379f et seq.) as added and amended by sections 101 and 108, is amended by adding at the end the following:

744.

(a)

The Secretary shall assess and collect an annual fee for the registration of an importer of food under section 801(s).

(b)

(1)

The registration fee under subsection (a) shall be—

(A)

for fiscal year 2010, $500; and

(B)

for fiscal year 2011 and each subsequent fiscal year, the fee for fiscal year 2010 as adjusted under paragraph (2).

(2)

For fiscal year 2011 and subsequent fiscal years, the fees established pursuant to paragraph (1) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year to reflect the greater of—

(A)

the total percentage change that occurred in the Consumer Price Index for all urban consumers (all items; United States city average), for the 12-month period ending June 30 preceding the fiscal year for which fees are being established;

(B)

(C)

(3)

The adjustment made each fiscal year pursuant this subsection shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2010 under this subsection.

(4)

In the case of a person who is required to pay both a fee under section 743 for registration of one or more facilities under section 415 and a fee under this section for registration as an importer of food under section 801(s), the Secretary shall waive the fees applicable to such person under section 743 or the fee applicable to such person under this section.

(c)

(1)

(2)

The fees authorized by this section—

(A)

shall be retained in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation, for such fiscal year; and

(B)

shall only be collected and available to cover the costs associated with registering importers under section 801(s) and with ensuring compliance with good importer practices respecting food.

(3)

For each of fiscal years 2010 through 2014, there are authorized to be appropriated for fees under this section such sums as may be necessary.

(c)

Section 704 (21 U.S.C. 374), as amended by section 105, is amended by adding at the end the following:

(i)

Every person engaged in the importing of any food shall, upon request of an officer or employee designated by the Secretary, permit such officer or employee at all reasonable times to inspect the facilities of such person and have access to, and to copy and verify, any related records.

205.

(a)

(1)

Section 301(zz) (21 U.S.C. 331), as added by section 204, is amended by inserting or 801(t) after 801(s).

(2)

Section 403(ee) (21 U.S.C. 343), as added by section 204, is amended—

(A)

by inserting or a customs broker after by an importer; and

(B)

by inserting or 801(t) after 801(s).

(3)

Section 801, as amended by sections 109, 136, and 204, is amended by adding at the end the following:

(t)

(1)

The Secretary shall require a customs broker, with respect to the importation of food—

(A)

to be registered with the Secretary in a form and manner specified by the Secretary; and

(B)

consistent with section 1011, to submit appropriate unique facility identifiers as a condition of registration.

(2)

(A)

(B)

Cancellation shall be preceded by notice to the customs broker of the intent to cancel the registration and the basis for such cancellation.

(C)

If the registration for the customs broker is updated or corrected no later than 7 days after notice is provided under subparagraph (B), the Secretary shall not cancel such registration.

(3)

The Secretary shall notify the Commissioner responsible for Customs and Border Protection whenever the Secretary cancels a registration under this subsection.

(4)

In consultation with the Commissioner responsible for Customs and Border Protection, the Secretary, by notice published in the Federal Register—

(A)

shall establish an exemption from the requirements of this subsection for importations for personal use; and

(B)

may establish other exemptions from the requirements of this subsection.

(5)

Notwithstanding any other provision in this Act, a customs broker who violates section 301 because of a violation of section 403(ee), or who violates section 301(xx), 301(yy), or 301(zz), shall not be subject to a civil penalty under section 303(f)(2).

(4)

Not later than 24 months after the date of the enactment of this Act, the Secretary of Health and Human Services, in consultation with the Commissioner responsible for Customs and Border Protection, shall promulgate the regulations required to carry out section 801(t) of the Federal Food, Drug, and Cosmetic Act, as added by paragraph (2).

(5)

The amendments made by this subsection shall take effect on the date that is 24 months after the date of enactment of this Act.

(b)

Section 704 (21 U.S.C. 374), as amended by sections 105 and 204, is amended by adding at the end the following:

(j)

Every customs broker required to be registered with the Secretary shall, upon request of an officer or employee designated by the Secretary, permit such officer or employee at all reasonable times to inspect the facilities of such person and have access to, and to copy and verify, any related records.

206.

Chapter X (21 U.S.C. 391 et seq) is amended by adding at the end the following:

1011.

(a)

A person required to register a facility pursuant to section 415 shall submit, at the time of registration, a unique facility identifier for the facility or establishment.

(b)

A person required to register pursuant to section 801(s) or 801(t) shall submit, at the time of registration, a unique facility identifier for the principal place of business for which such person is required to register under section 801(s) or 801(t).

(c)

The Secretary may, by guidance, and, with respect to importers and customs brokers, in consultation with the Commissioner responsible for Customs and Border Protection, specify the unique numerical identifier system to be used to meet the requirements of subsections (a) and (b) and the form, manner, and timing of a submission under such subsections. Development of such guidelines shall take into account the utilization of existing unique identification schemes and compatibility with customs automated systems, such as integration with the Automated Commercial Environment (ACE) and the International Trade Data System (ITDS), and any successor systems.

(d)

An article of food imported or offered for import shall be refused admission unless the appropriate unique facility identifiers, as specified by the Secretary, are provided for such article.

207.

(a)

Section 402 (21 U.S.C. 342), as amended by section 102, 103(a), and 104(a), is amended by adding at the end the following:

(n)

If it has been produced, manufactured, processed, packed, or held in any farm, factory, warehouse, or establishment and the owner, operator, or agent of such farm, factory, warehouse, or establishment, or any agent of a governmental authority in the foreign country within which such farm, factory, warehouse, or establishment is located, delays or limits an inspection, or refuses to permit entry or inspection, under section 414 or 704.

(b)

Section 704(a)(1) (21 U.S.C. 374(a)(1)), as amended by section 106(c), is amended—

(1)

in the first sentence, by inserting , including any such food factory, warehouse, or establishment whether foreign or domestic, after factory, warehouse, or establishment; and

(2)

in the third sentence, by inserting , including any food factory, warehouse, establishment, or consulting laboratory whether foreign or domestic, after factory, warehouse, establishment, or consulting laboratory.

208.

Section 704 (21 U.S.C. 374), as amended by sections 105, 204, and 205, is amended by adding at the end the following:

(k)

The Secretary shall establish and maintain a corps of inspectors dedicated to inspections of foreign food facilities. This corps shall be staffed and funded by the Secretary at a level sufficient to enable it to assist the Secretary in achieving the frequency of inspections for food facilities as described in this Act.

209.

(a)

Not later than 90 days before the Secretary terminates or consolidates any laboratory, district office, or the functions (including the inspection and compliance functions) of any such laboratory or district office, specified in subsection (b), the Secretary shall submit a reorganization plan to the Comptroller General of the United States, the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate.

(b)

The laboratories and offices specified in this subsection are the following:

(1)

Any of the 13 field laboratories responsible for analyzing food that were operated by the Office of Regulatory Affairs of the Food and Drug Administration as of January 1, 2007.

(2)

Any of the 20 district offices of the Food and Drug Administration with responsibility for food safety functioning as of January 1, 2007.

(c)

A reorganization plan described in subsection (a) is deemed to be a major rule (as defined in section 804(2) of title 5, United States Code) for purposes of chapter 8 of such title.

210.

(a)

Section 301(q)(2) (21 U.S.C. 331(q)(2)) is amended by inserting after device the following: , food,.

(b)

The amendment made by subsection (a) shall apply to submissions made on or after the date of the enactment of this Act.

211.

(a)

Section 301(f) is amended by inserting before the period or the failure or refusal to obey a subpoena issued pursuant to section 311.

(b)

Chapter III (21 U.S.C. 331 et seq.) is amended by adding at the end the following:

311.

(a)

For the purpose of—

(1)

any hearing, investigation, or other proceeding respecting a violation of a provision of this Act, the Public Health Service Act, or the Federal Anti-Tampering Act, relating to food; or

(2)

any hearing, investigation, or other proceeding to determine if a person is in violation of a specific provision of this Act, the Public Health Service Act, or the Federal Anti-Tampering Act, relating to food,

the Commissioner may issue subpoenas requiring the attendance and testimony of witnesses and the production of records and other things.

(b)

When the Commissioner deems that immediate compliance with a subpoena issued under this section is necessary to address a threat of serious adverse health consequences or death, the subpoena may require immediate production.

(c)

(1)

Subpoenas of the Commissioner shall be served by a person authorized by the Commissioner by delivering a copy thereof to the person named therein or by certified mail addressed to such person at such person’s last known dwelling place or principal place of business.

(2)

Service on a domestic or foreign corporation, partnership, unincorporated association, or other entity that is subject to suit under a common name may be made by delivering the subpoena to an officer, a managing or general agent, or any other agent authorized by appointment or by law to receive service of process.

(3)

Service on any person not found within the territorial jurisdiction of any court of the United States may be made in any manner as the Federal Rules of Civil Procedure prescribe for service in a foreign nation.

(4)

A verified return by the person so serving the subpoena setting forth the manner of service, or, in the case of service by certified mail, the return post office receipt therefor signed by the person so served, shall be proof of service.

(d)

Witnesses subpoenaed under subsection (a) shall be paid the same fees and mileage as are paid witnesses in the district courts of the United States.

(e)

In the case of a refusal to obey a subpoena duly served upon any person under subsection (a), any district court of the United States for the judicial district in which such person charged with refusal to obey is found, resides, or transacts business, upon application by the Commissioner, shall have jurisdiction to issue an order compelling compliance with the subpoena and requiring such person to appear and give testimony or to appear and produce records and other things, or both. The failure to obey such order of the court may be punished by the court as contempt thereof. If the person charged with failure or refusal to obey is not found within the territorial jurisdiction of the United States, the United States District Court for the District of Columbia shall have the same jurisdiction, consistent with due process, to take any action respecting compliance with the subpoena by such person that such district court would have if such person were personally within the jurisdiction of such district court.

(f)

A United States district court for the district in which the subpoena is or will be served, upon application of the Commissioner, may issue an ex parte order that no person or entity disclose to any other person or entity (other than to an attorney to obtain legal advice) the existence of such subpoena for a period of up to 90 days. Such order may be issued on a showing that the records or things being sought may be relevant to the hearing, investigation, proceeding, or other matter and that there is reason to believe that such disclosure may result in—

(1)

furtherance of a potential violation under investigation;

(2)

endangerment to the life or physical safety of any person;

(3)

flight or other action to avoid prosecution or other enforcement remedies;

(4)

destruction of or tampering with evidence; or

(5)

intimidation of potential witnesses.

An order under this subsection may be renewed for additional periods of up to 90 days upon a showing that any of the circumstances described in paragraphs (1) through (5) continue to exist.

(g)

The subpoena authority vested in the Commissioner and the district courts of the United States by this section is in addition to any such authority vested in the Commissioner or such courts by other provisions of law, or as is otherwise authorized by law.

(h)

The authority to issue a subpoena under this section is limited to the Secretary or an official designated by the Secretary. An official may not be so designated unless the official is the director of the district under this Act in which the article involved is located, or is an official senior to such director.

212.

Chapter X (21 U.S.C. 391 et seq.), as amended by section 206, is amended by adding at the end the following:

1012

(a)

No person who submits or is required under this Act or the Public Health Service Act to submit any information related to a food, or any officer, employee, contractor, subcontractor, or agent of such person may discharge, demote, suspend, threaten, harass, or in any other manner discriminate against an employee in the terms and conditions of employment because of any lawful act done by the employee, including within the ordinary course of the job duties of such employee—

(1)

to provide information, cause information to be provided, or otherwise assist in any investigation regarding any conduct which the employee reasonably believes constitutes a violation of this Act, or any other provision of Federal law relating to the safety of a food, if the information or assistance is provided to, or an investigation stemming from the provided information is conducted by—

(A)

a Federal regulatory or law enforcement agency;

(B)

any Member of Congress or any committee of Congress; or

(C)

a person with supervisory authority over the employee (or such other person working for the employer who has the authority to investigate, discover, or terminate the misconduct);

(2)

to file, cause to be filed, testify, participate in, or otherwise assist in a proceeding filed, or about to be filed (with any knowledge of the employer), in any court or administrative forum relating to any such alleged violation; or

(3)

to refuse to commit or assist in any such violation.

(b)

(1)

An employee who alleges discharge or other discrimination in violation of subsection (a) may seek relief in accordance with the provisions of subsection (c) by—

(A)

filing a complaint with the Secretary of Labor; or

(B)

if the Secretary of Labor has not issued a final decision within 210 days of the filing of the complaint and there is no showing that such delay is due to the bad faith of the claimant, or within 90 days after receiving a final decision or order from the Secretary, bringing an action at law or equity for de novo review in the appropriate district court of the United States, which court shall have jurisdiction over such action without regard to the amount in controversy, and which action shall, at the request of either party to such action, be tried by the court with a jury.

(2)

(A)

Any action under paragraph (1) shall be governed under the rules and procedures set forth in section 42121(b) of title 49, United States Code.

(B)

Notification in an action under paragraph (1) shall be made in accordance with section 42121(b)(1) of title 49, United States Code, except that such notification shall be made to the person named in the complaint, the employer, and the Commissioner of Food and Drugs.

(C)

An action brought under paragraph (1)(A) or (1)(B) shall be governed by the legal burdens of proof set forth in section 42121(b) of title 49, United States Code.

(D)

An action under paragraph (1)(A) shall be commenced not later than 180 days after the date on which the violation occurs.

(c)

(1)

An employee prevailing in any action under subsection (b)(1) shall be entitled to all relief necessary to make the employee whole.

(2)

If, in response to a complaint filed under paragraph (b)(1), the Secretary of Labor or the district court, as applicable, determines that a violation of subsection (a) has occurred, the Secretary or the court shall order the person who committed such violation—

(A)

to take affirmative action to abate the violation;

(B)

to—

(i)

reinstate the complainant to his or her former position together with compensation (including back pay); and

(ii)

restore the terms, conditions, and privileges associated with his or her employment; and

(C)

to provide compensatory damages to the complainant.

If such an order is issued under this paragraph, the Secretary or the court, at the request of the complainant, shall assess against the person against whom the order is issued a sum equal to the aggregate amount of all costs and expenses (including attorney and expert witness fees) reasonably incurred, as determined by the Secretary, by the complainant for, or in connection with, the bringing of the complaint upon which the order was issued.

(d)

Nothing in this section shall be deemed to diminish the rights, privileges, or remedies of any employee under any Federal or State law or under any collective bargaining agreement. The rights and remedies in this section may not be waived by any agreement, policy, form, or condition of employment.

213.

(a)

Section 301 (21 U.S.C. 331), as amended by sections 110, 111, 133, 136, and 204, is amended by adding at the end the following:

(aaa)

The production, manufacture, processing, preparation, packing, holding, or distribution of an adulterated or misbranded food with the knowledge or intent that such article will be imported into the United States.

(b)

Chapter III (21 U.S.C. 331 et seq.), as amended by section 211, is amended by adding at the end the following:

312.

There is extraterritorial Federal jurisdiction over any violation of this Act relating to any article of food if such article was intended for import into the United States or if any act in furtherance of the violation was committed in the United States.

214.

The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall provide financial and other assistance to appropriate entities to establish and maintain one or more university-affiliated food protection training institutes that—

(1)

conduct training related to food protection activities for Federal, State, local, territorial, and tribal officials; and

(2)

meet standards developed by the Secretary.

215.

(a)

No later than December 31, 2009, the Secretary of Health and Human Services shall notify the Congress whether the available scientific data support a determination that there is a reasonable certainty of no harm, for infants, young children, pregnant women, and adults, for approved uses of polycarbonate plastic and epoxy resin made with bisphenol A in food and beverage containers, including reusable food and beverage containers, under the conditions of use prescribed in current Food and Drug Administration regulations.

(b)

If the Secretary concludes that such a determination cannot be made for any approved use, the Secretary shall notify the Congress of the actions the Secretary intends to take under the Secretary’s authority to regulate food additives to protect the public health, which may include—

(1)

revoking or modifying any of the approved uses of bisphenol A in food and beverage containers, including reusable food and beverage containers; and

(2)

ensuring that the public is sufficiently informed of such determination and the steps the public may take in response to such determination.

(c)

Nothing herein is intended or shall be construed to modify existing Food and Drug Administration authority, procedures, or policies for assessing scientific data, making safety determinations, or regulating the safe use of food additives.

216.

(a)

Section 403 (21 U.S.C. 343), as amended by sections 101(a), 109(a), 114(a), 202, and 204, is amended by adding at the end the following:

(ff)

If it is ceramic tableware or cookware and includes a glaze or decorations containing lead for an intended functional purpose, unless—

(1)

the product and its packaging bear the statement: This product is made with lead-based glaze consistent with Food and Drug Administration guidelines for such lead.; or

(2)

the product is in compliance with the requirements applicable to ornamental and decorative ceramicware in section 109.16 of title 21, Code of Federal Regulations (or any successor regulation).

(b)

Section 403(ff) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), shall apply only to ceramic tableware or cookware that is manufactured on or after the date that is 1 year after the date of the enactment of this Act.

(c)

Chapter IV (21 U.S.C. 341 et seq.), as amended by sections 102, 103, 104, and 111, is amended by adding at the end the following:

421.

(a)

The Secretary shall educate consumers on the safety of ceramicware for food use by posting information on the Web site of the Food and Drug Administration with regard to—

(1)

the content of lead in ceramicware and its glaze;

(2)

existing Federal laws and regulations governing lead in ceramicware;

(3)

as appropriate, existing industry practices and guidelines; and

(4)

the labeling requirements applicable under this Act.

(b)

The education under this section shall address—

(1)

the broad range of ceramicware types, including traditional pottery, ornamental and decorative ceramicware, cookware, and everyday dinnerware;

(2)

the safety of ceramicware that is aged or damaged;

(3)

the use of ceramicware in microwave ovens;

(4)

the storage of foods in ceramicware;

(5)

the use of home lead test kits by consumers;

(6)

the use of ceramicware by children and women of childbearing age; and

(7)

issues that are especially relevant to subpopulations of consumers who may preferentially use certain types of ceramicware made with lead.

Passed the House of Representatives July 30, 2009.

Lorraine C. Miller,

Clerk.

H.R. 2749 (111^th): Food Safety Enhancement Act of 2009

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H.R. 2749 (111th): Food Safety Enhancement Act of 2009

This bill has 4 versions. Select a version to view: June 8, 2009: Introduced July 29, 2009: Reported by House Committee July 30, 2009: Passed the House Aug. 3, 2009: Referred to Senate Committee

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H.R. 2749 (111^th): Food Safety Enhancement Act of 2009

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