Behold, the works of sorcerers of legend do pale in comparison to the alimental powers of manifestation from the ethers commanded by Senator Harry Reid during a December 19, 2010 conjuration in the mostly empty senate chambers, behold, the dreaded 236 page FDA Food Safety Modernization Act:
Mr. REID. Mr. President, I ask unanimous consent that the Senate proceed to Calendar No. 74, H.R. 2751.
The PRESIDING OFFICER. The clerk will report the bill by title.
The legislative clerk read as follows:
A bill (H.R. 2751) to accelerate motor fuel savings nationwide and provide incentives to registered owners of high polluting automobiles to replace such automobiles with new fuel efficient and less polluting automobiles.
Mr. REID. I ask unanimous consent that the text of S. 510, as passed the Senate and modified with the changes at the desk, be inserted in lieu thereof and agreed to; that the bill, as amended, be read a third time.
The PRESIDING OFFICER. Without objection, it is so ordered
The amendment (No. 4890), in the nature of a substitute, as modified, was agreed to.
(The amendment is printed in todays Record under “Text of Amendments.)
The amendment was ordered to be engrossed and the bill to be read a third time.
The bill was read the third time.
Mr. REID. Is there a question on passage of the bill?
The PRESIDING OFFICER. The bill, having been read the third time, the question is, Shall the bill pass?
The bill, (H.R. 2751), as amended, was passed.
Mr. REID. I move to reconsider and table the vote.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. REID. Mr. President, I ask unanimous consent that the title amendment, which is at the desk, be considered and agreed to, and the motion to reconsider be laid upon the table, and any statements related to the measure be printed in the Record.
The PRESIDING OFFICER. Without objection, it is so ordered.
The amendment (No. 4891) was agreed to, as follows:
Amend the title as to read: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the safety of the food supply.
SEC. 101. INSPECTIONS OF RECORDS.
(a) In General- Section 414(a) (21 U.S.C. 350c(a)) is amended–
(1) by striking the heading and all that follows through ‘of food is’ and inserting the following: ‘Records Inspection-
(1) ADULTERATED FOOD- If the Secretary has a reasonable belief that an article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, is’;
(2) by inserting ‘, and to any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner,’ after ‘relating to such article’;
SEC. 102. REGISTRATION OF FOOD FACILITIES.
(a) Updating of Food Category Regulations; Biennial Registration Renewal- Section 415(a) (21 U.S.C. 350d(a)) is amended–
(b) Suspension of Registration-
(1) IN GENERAL- If the Secretary determines that food manufactured, processed, packed, received, or held by a facility registered under this section has a reasonable probability of causing serious adverse health consequences or death to humans or animals, the Secretary may by order suspend the registration of a facility–
(A) that created, caused, or was otherwise responsible for such reasonable probability; or
(B)(i) that knew of, or had reason to know of, such reasonable probability; and
(ii) packed, received, or held such food.
(4) EFFECT OF SUSPENSION- If the registration of a facility is suspended under this subsection, no person shall import or export food into the United States from such facility, offer to import or export food into the United States from such facility, or otherwise introduce food from such facility into interstate or intrastate commerce in the United States
(c) Clarification of Intent
(1) RETAIL FOOD ESTABLISHMENT- The Secretary shall amend the definition of the term ‘retail food establishment’ in section in 1.227(b)(11) of title 21, Code of Federal Regulations to clarify that, in determining the primary function of an establishment or a retail food establishment under such section, the sale of food products directly to consumers by such establishment and the sale of food directly to consumers by such retail food establishment include–
(A) the sale of such food products or food directly to consumers by such establishment at a roadside stand or farmers’ market where such stand or market is located other than where the food was manufactured or processed;
(B) the sale and distribution of such food through a community supported agriculture program; and
(C) the sale and distribution of such food at any other such direct sales platform as determined by the Secretary.
(2) DEFINITIONS- For purposes of paragraph (1)–
(A) the term ‘community supported agriculture program’ has the same meaning given the term ‘community supported agriculture (CSA) program’ in section 249.2 of title 7, Code of Federal Regulations (or any successor regulation); and
(B) the term ‘consumer’ does not include a business.
SEC. 103. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS.
(b) Hazard Analysis- The owner, operator, or agent in charge of a facility shall–
(1) identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility, including–
(A) biological, chemical, physical, and radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives; and
(B) hazards that occur naturally, or may be unintentionally introduced; and
(2) identify and evaluate hazards that may be intentionally introduced, including by acts of terrorism; and
(3) develop a written analysis of the hazards.
(l) Modified Requirements for Qualified Facilities- SMALL FARMS, SMALL BUSINESSES
(1) QUALIFIED FACILITIES-
(A) IN GENERAL- A facility is a qualified facility for purposes of this subsection if the facility meets the conditions under subparagraph (B) or (C).
(B) VERY SMALL BUSINESS- A facility is a qualified facility under this subparagraph–
(i) if the facility, including any subsidiary or affiliate of the facility, is, collectively, a very small business (as defined in the regulations promulgated under subsection (n)); and
(ii) in the case where the facility is a subsidiary or affiliate of an entity, if such subsidiaries or affiliates, are, collectively, a very small business (as so defined).
(C) LIMITED ANNUAL MONETARY VALUE OF SALES-
(i) IN GENERAL- A facility is a qualified facility under this subparagraph if clause (ii) applies–
(I) to the facility, including any subsidiary or affiliate of the facility, collectively; and
(II) to the subsidiaries or affiliates, collectively, of any entity of which the facility is a subsidiary or affiliate.
(ii) AVERAGE ANNUAL MONETARY VALUE.-This clause applies if-
(I) during the 3-year period preceding the applicable calendar year, the average annual monetary value of the food manufactured, processed, packed, or held at such facility (or the collective average annual monetary value of such food at any subsidiary or affiliate, as described in clause (i)) that is sold directly to qualified end-users during such period exceeded the average annual monetary value of the food manufactured, processed, packed, or held at such facility (or the collective average annual monetary value of such food at any subsidiary or affiliate, as so described) sold by such facility (or collectively by any such subsidiary or affiliate) to all other purchasers during such period; and
(II) the average annual monetary value of all food sold by such facility (or the collective average annual monetary value of such food sold by any subsidiary or affiliate, as described in clause (i)) during such period was less than $500,000, adjusted for inflation.
(2) EXEMPTION- A qualified facility–
(B) shall submit to the Secretary–
(i)(I) documentation that demonstrates that the owner, operator, or agent in charge of the facility has identified potential hazards associated with the food being produced, is implementing preventive controls to address the hazards, and is monitoring the preventive controls to ensure that such controls are effective; or
(II) documentation (which may include licenses, inspection reports, certificates, permits, credentials, certification by an appropriate agency (such as a State department of agriculture), or other evidence of oversight), as specified by the Secretary, that the facility is in compliance with State, local, county, or other applicable non-Federal food safety law; and
(ii) documentation, as specified by the Secretary in a guidance document issued not later than 1 year after the date of enactment of this section, that the facility is a qualified facility under paragraph (1)(B) or (1)(C).
(5) STUDY-
(A) IN GENERAL- The Secretary of Agriculture, shall conduct a study of the food processing sector regulated by the Secretary to determine–
(i) the distribution of food production by type and size of operation, including monetary value of food sold;
(ii) the proportion of food produced by each type and size of operation;
(iii) the number and types of food facilities co-located on farms, including the number and proportion by commodity and by manufacturing or processing activity;
(B) SIZE- The results of the study conducted under subparagraph (A) shall include the information necessary to enable the Secretary to define the terms ‘small business’ and ‘very small business’, for purposes of promulgating the regulation under subsection (n). In defining such terms, the Secretary shall include consideration of harvestable acres, income, the number of employees, and the volume of food harvested.
(7) NOTIFICATION TO CONSUMERS
(A) IN GENERAL- A qualified facility that is exempt from the requirements under subsections (a) through (i) and subsection (n) and does not prepare documentation under paragraph (2)(B)(i)(I) shall–
(i) with respect to a food for which a food packaging label is required by the Secretary under any other provision of this Act, include prominently and conspicuously on such label the name and business address of the facility where the food was manufactured or processed; or
(ii) with respect to a food for which a food packaging label is not required by the Secretary under any other provisions of this Act, prominently and conspicuously display, at the point of purchase, the name and business address of the facility where the food was manufactured or processed, on a label, poster, sign, placard, or documents delivered contemporaneously with the food in the normal course of business, or, in the case of Internet sales, in an electronic notice.
(B) NO ADDITIONAL LABEL- Subparagraph (A) does not provide authority to the Secretary to require a label that is in addition to any label required under any other provision of this Act.
(n) Regulations-
(1) IN GENERAL- Not later than 18 months after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall promulgate regulations–
(A) to establish science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the implementation of the preventive controls under this section; and
(B) to define, for purposes of this section, the terms ‘small business’ and ‘very small business’, taking into consideration the study described in subsection (l)(5).
(2) COORDINATION- In promulgating the regulations under paragraph (1)(A), with regard to hazards that may be intentionally introduced, including by acts of terrorism, the Secretary shall coordinate with the Secretary of Homeland Security, as appropriate.
(D) not require a facility to hire a consultant or other third party to identify, implement, certify, or audit preventative controls, except in the case of negotiated enforcement resolutions that may require such a consultant or third party.
(3) PREVENTIVE CONTROLS
(C) An environmental monitoring program to verify the effectiveness of pathogen controls in processes where a food is exposed to a potential contaminant in the environment
(ii) LIMITATION- The exemptions or modifications under clause (i) shall not include an exemption from the requirement to register under section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d), as amended by this Act, if applicable, and shall apply only to small businesses and very small businesses, as defined in the regulation promulgated under section 418(n) of the Federal Food, Drug, and Cosmetic Act (as added under subsection (a)).
SEC. 105. STANDARDS FOR PRODUCE SAFETY.
(a) In General- Chapter IV (21 U.S.C. 341 et seq.), as amended by section 103, is amended by adding at the end the following:
SEC. 419. STANDARDS FOR PRODUCE SAFETY.
(a) Proposed Rulemaking-
(1) IN GENERAL-
(A) RULEMAKING- Not later than 1 year after the date of enactment of the FDA Food Safety Modernization Act, the Secretary, in coordination with the Secretary of Agriculture and representatives of State departments of agriculture (including with regard to the national organic program established under the Organic Foods Production Act of 1990), and in consultation with the Secretary of Homeland Security, shall publish a notice of proposed rulemaking to establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables, including specific mixes or categories of fruits and vegetables, that are raw agricultural commodities for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death.
(B) DETERMINATION BY SECRETARY- With respect to small businesses and very small businesses (as such terms are defined in the regulation promulgated under subparagraph (A)) that produce and harvest those types of fruits and vegetables that are raw agricultural commodities that the Secretary has determined are low risk and do not present a risk of serious adverse health consequences or death, the Secretary may determine not to include production and harvesting of such fruits and vegetables in such rulemaking, or may modify the applicable requirements of regulations promulgated pursuant to this section.
(3) CONTENT- The proposed rulemaking under paragraph (1) shall-
(B) include, with respect to growing, harvesting, sorting, packing, and storage operations, science-based minimum standards related to soil amendments, hygiene, packaging, temperature controls, animals in the growing area, and water;
(C) consider hazards that may be unintentionally introduced, or may be intentionally introduced, including by acts of terrorism;
(E) in the case of production that is certified organic, not include any requirements that conflict with or duplicate the requirements of the national organic program established under the Organic Foods Production Act of 1990, while providing the same level of public health protection as the requirements under guidance documents, including guidance documents regarding action levels, and regulations under the FDA Food Safety Modernization Act;
(c) Criteria-
(1) IN GENERAL- The regulations adopted under subsection (b) shall–
(A) set forth those procedures, processes, and practices that the Secretary determines to minimize the risk of serious adverse health consequences or death, including procedures, processes, and practices that the Secretary determines to be reasonably necessary 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 fruits and vegetables, including specific mixes or categories of fruits and vegetables, that are raw agricultural commodities and to provide reasonable assurances that the produce is not adulterated under section 402;
(F) permit States and foreign countries from which food is imported into the United States to request from the Secretary variances from the requirements of the regulations, subject to paragraph (2), where the State or foreign country determines that the variance is necessary in light of local growing conditions and that the procedures, processes, and practices to be followed under the variance are reasonably likely to ensure that the produce is not adulterated under section 402 and to provide the same level of public health protection as the requirements of the regulations adopted under subsection (b).
(f) Exemption for Direct Farm Marketing-
(1) IN GENERAL- A farm shall be exempt from the requirements under this section in a calendar year if–
(A) during the previous 3-year after the date on which the regulations promulgated under period, the average annual monetary value of the food sold by such farm directly to qualified end-users during such period exceeded the average annual monetary value of the food sold by such farm to all other buyers during such period; and
(B) the average annual monetary value of all food sold during such period was less than $500,000, adjusted for inflation
(3) WITHDRAWAL; RULE OF CONSTRUCTION-
(A) IN GENERAL- In the event of an active investigation of a foodborne illness outbreak that is directly linked to a farm subject to an exemption under this subsection, or if the Secretary determines that it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with a farm that are material to the safety of the food produced or harvested at such farm, the Secretary may withdraw the exemption provided to such farm under this subsection.
SEC. 106. PROTECTION AGAINST INTENTIONAL ADULTERATION.
(a) In General- Chapter IV (21 U.S.C. 341 et seq.), as amended by section 105, is amended by adding at the end the following:
SEC. 420. PROTECTION AGAINST INTENTIONAL ADULTERATION.
(a) Determinations-
(1) IN GENERAL- The Secretary shall–
(C) determine the types of science-based mitigation strategies or measures that are necessary to protect against the intentional adulteration of food.
(d) Exception- This section shall not apply to farms, except for those that produce milk.
SEC. 109. FOOD AND AGRICULTURE COORDINATING COUNCILS.
The Secretary of Homeland Security, in coordination with the Secretary of Health and Human Services and the Secretary of Agriculture, shall within 180 days of enactment of this Act, and annually thereafter, submit to the relevant committees of Congress, and make publicly available on the Internet Web site of the Department of Homeland Security, a report on the activities of the Food and Agriculture Government Coordinating Council and the Food and Agriculture Sector Coordinating Council, including the progress of such Councils on–
(1) facilitating partnerships between public and private entities to help coordinate and enhance the protection of the agriculture and food system of the United States
SEC. 110. BUILDING DOMESTIC CAPACITY.
(a) In General-
(1) INITIAL REPORT- The Secretary, in coordination with the Secretary of Agriculture and the Secretary of Homeland Security, shall, not later than 2 years after the date of enactment of this Act, submit to Congress a comprehensive report that identifies programs and practices that are intended to promote the safety and supply chain security of food and to prevent outbreaks of foodborne illness and other food-related hazards that can be addressed through preventive activities. Such report shall include a description of the following:
(H) The impact of requirements under this Act (including amendments made by this Act) on certified organic farms and facilities (as defined in section 415 (21 U.S.C. 350d).
(I) Specific efforts taken pursuant to the agreements authorized under section 421(c) of the Federal Food, Drug, and Cosmetic Act (as added by section 201), together with, as necessary, a description of any additional authorities necessary to improve seafood safety.
SEC. 111. SANITARY TRANSPORTATION OF FOOD.
(b) Food Transportation Study- The Secretary, acting through the Commissioner of Food and Drugs, shall conduct a study of the transportation of food for consumption in the United States, including transportation by air, that includes an examination of the unique needs of rural and frontier areas with regard to the delivery of safe food.
SEC. 204. ENHANCING TRACKING AND TRACING OF FOOD AND RECORDKEEPING.
(d)
(2) DESIGNATION OF HIGH-RISK FOODS-
(A) IN GENERAL- Not later than 1 year after the date of enactment of this Act, and thereafter as the Secretary determines necessary, the Secretary shall designate high-risk foods for which the additional recordkeeping requirements described in paragraph (1) are appropriate and necessary to protect the public health. Each such designation shall be based on–
(i) the known safety risks of a particular food, including the history and severity of foodborne illness outbreaks attributed to such food, taking into consideration foodborne illness data collected by the Centers for Disease Control and Prevention;
(ii) the likelihood that a particular food has a high potential risk for microbiological or chemical contamination or would support the growth of pathogenic microorganisms due to the nature of the food or the processes used to produce such food;
(iii) the point in the manufacturing process of the food where contamination is most likely to occur;
(iv) the likelihood of contamination and steps taken during the manufacturing process to reduce the possibility of contamination;
(v) the likelihood that consuming a particular food will result in a foodborne illness due to contamination of the food; and
(vi) the likely or known severity, including health and economic impacts, of a foodborne illness attributed to a particular food.
(B) LIST OF HIGH-RISK FOODS- At the time the Secretary promulgates the final rules under paragraph (1), the Secretary shall publish the list of the foods designated under subparagraph (A) as high-risk foods on the Internet website of the Food and Drug Administration. The Secretary may update the list to designate new high-risk foods and to remove foods that are no longer deemed to be high-risk foods, provided that each such update to the list is consistent with the requirements of this subsection and notice of such update is published in the Federal Register.
(3) PROTECTION OF SENSITIVE INFORMATION- In promulgating regulations under this subsection, the Secretary shall take appropriate measures to ensure that there are effective procedures to prevent the unauthorized disclosure of any trade secret or confidential information that is obtained by the Secretary pursuant to this section, including periodic risk assessment and planning to prevent unauthorized release and controls to–
(A) prevent unauthorized reproduction of trade secret or confidential information;
(B) prevent unauthorized access to trade secret or confidential information; and
(C) maintain records with respect to access by any person to trade secret or confidential information maintained by the agency
(H) FARM SALES TO CONSUMERS- The Secretary shall not require a farm to maintain any distribution records under this subsection with respect to a sale of a food described in subparagraph (I) (including a sale of a food that is produced and packaged on such farm), if such sale is made by the farm directly to a consumer.
(I) SALE OF A FOOD- A sale of a food described in this subparagraph is a sale of a food in which–
(i) the food is produced on a farm; and
(ii) the sale is made by the owner, operator, or agent in charge of such farm directly to a consumer or grocery store.
(h) Small Entity Compliance Guide- Not later than 180 days after promulgation of a final rule under subsection (d), the Secretary shall issue a small entity compliance guide setting forth in plain language the requirements of the regulations under such subsection in order to assist small entities, including farms and small businesses, in complying with the recordkeeping requirements under such subsection.
(i) Flexibility for Small Businesses- Notwithstanding any other provision of law, the regulations promulgated under subsection (d) shall apply–
(1) to small businesses (as defined by the Secretary in section 103, not later than 90 days after the date of enactment of this Act) beginning on the date that is 1 year after the effective date of the final regulations promulgated under subsection (d); and
(2) to very small businesses (as defined by the Secretary in section 103, not later than 90 days after the date of enactment of this Act) beginning on the date that is 2 years after the effective date of the final regulations promulgated under subsection (d).
(j) Enforcement-
(1) PROHIBITED ACTS- Section 301(e) (21 U.S.C. 331(e)) is amended by inserting ‘; or the violation of any recordkeeping requirement under section 204 of the FDA Food Safety Modernization Act (except when such violation is committed by a farm)’ before the period at the end. (LOOPHOLE 2)
SEC. 207. ADMINISTRATIVE DETENTION OF FOOD.
(a) In General- Section 304(h)(1)(A) (21 U.S.C. 334(h)(1)(A)) is amended by–
(1) striking ‘credible evidence or information indicating’ and inserting ‘reason to believe’; and
(2) striking ‘presents a threat of serious adverse health consequences or death to humans or animals’ and inserting ‘is adulterated or misbranded’.
SEC. 401. FUNDING FOR FOOD SAFETY.
(a) In General- There are authorized to be appropriated to carry out the activities of the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, and related field activities in the Office of Regulatory Affairs of the Food and Drug Administration such sums as may be necessary for fiscal years 2011 through 2015.
(b) Increased Number of Field Staff-
(1) IN GENERAL- To carry out the activities of the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, and related field activities of the Office of Regulatory Affairs of the Food and Drug Administration, the Secretary of Health and Human Services shall increase the field staff of such Centers and Office with a goal of not fewer than–
(A) 4,000 staff members in fiscal year 2011;
(B) 4,200 staff members in fiscal year 2012;
(C) 4,600 staff members in fiscal year 2013; and
(D) 5,000 staff members in fiscal year 2014.
(2) FIELD STAFF FOR FOOD DEFENSE- The goal under paragraph (1) shall include an increase of 150 employees by fiscal year 2011 to–
(A) provide additional detection of and response to food defense threats; and
(B) detect, track, and remove smuggled food (as defined in section 309) from commerce.