FSMA Guidance for Industry – Adulteration

Guidance for Industry: measures to address the risk for contamination by salmonella species in food containing a pistachio-derived product as an ingredient: https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Salmonella/ucm273482.htm

FSMA –

“(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”;

  • Process controls include procedures that ensure the control of parameters during certain processing operations such as cooking, refrigerating, and acidifying foods. They must include parameters and values (e.g., parameter values), as appropriate to the nature of the applicable control and its role in the facility’s food safety system.  
  • Sanitation controls are procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition to minimize or prevent hazards such as environmental pathogens and hazards from employees handling animal food.
  • Other Controls are controls that are not described above but are necessary to ensure that a hazard requiring a preventive control will be significantly minimized or prevented. 
  • Corrective actions: These include actions to identify and correct a problem implementing a preventive control, reduce the likelihood the problem will recur, evaluate affected animal food for safety, and prevent that food from entering commerce if you cannot ensure that the affected food is not adulterated. Corrective actions must be documented.

“SEC. 423. <<NOTE: 21 USC 350l.>> MANDATORY RECALL AUTHORITY.
“(a) Voluntary Procedures. <<NOTE: Determination.>> –If the Secretary determines, based on information gathered through the reportable food registry under section 417 or through any other means, that there is a reasonable probability that an article of food (other than infant formula) is adulterated under section 402 or misbranded under section 403(w) and the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals, the Secretary shall provide the responsible party (as defined in section 417) with an opportunity to cease distribution and recall such article.
“(b) Prehearing Order To Cease Distribution and Give Notice.–
“(1) In general.–If the responsible party refuses to or does not voluntarily cease distribution or recall such article within the time and in the manner prescribed by the Secretary (if so prescribed), the Secretary may, by order require, as the Secretary deems necessary, such person to–
“(A) immediately cease distribution of such article; and
“(B) as applicable, immediately notify all persons–
“(i) manufacturing, processing, packing, transporting, distributing, receiving, holding, or importing and selling such article; and
“(ii) to which such article has been distributed, transported, or sold, to immediately cease distribution of such article.
“(2) Required additional information.–
“(A) In general.–If an article of food covered by a recall order issued under paragraph (1)(B) has been distributed to a warehouse-based third party logistics provider without providing such provider sufficient information to know or reasonably determine the precise identity of the article of food covered by a recall order that is in its possession, the notice provided by the responsible party subject to the order issued under paragraph (1)(B) shall include such information as is necessary for the warehouse-based third party logistics provider to identify the food.
“(B) Rules of construction.–Nothing in this paragraph shall be construed–
“(i) to exempt a warehouse-based third party logistics provider from the requirements of this Act, including the requirements in this section and section 414; or
“(ii) to exempt a warehouse-based third party logistics provider from being the subject of a mandatory recall order.
“(3) Determination to limit areas affected.–If the Secretary requires a responsible party to cease distribution under paragraph (1)(A) of an article of food identified in subsection (a), the Secretary may limit the size of the geographic area and the markets affected by such cessation if such limitation would not compromise the public health.
“(c) Hearing on Order. <<NOTE: Deadline.>> –The Secretary shall provide the responsible party subject to an order under subsection (b) with an opportunity for an informal hearing, to be held as soon as possible, but not later than 2 days after the issuance of the order, [[Page 124 STAT. 3941]] on the actions required by the order and on why the article that is the subject of the order should not be recalled.
“(d) Post-hearing Recall Order and Modification of Order.–
“(1) Amendment of order.–If, after providing opportunity for an informal hearing under subsection (c), the Secretary determines that removal of the article from commerce is necessary, the Secretary shall, as appropriate–
“(A) amend the order to require recall of such article or other appropriate action;
“(B) specify a timetable in which the recall shall occur;
“(C) require periodic reports to the Secretary describing the progress of the recall; and”(D) provide notice to consumers to whom such article was, or may have been, distributed.
“(2) Vacating of order.–If, after such hearing, the Secretary determines that adequate grounds do not exist to continue the actions required by the order, or that such actions should be modified, the Secretary shall vacate the order or modify the order.
“(e) Rule Regarding Alcoholic Beverages.–The Secretary shall not initiate a mandatory recall or take any other action under this section with respect to any alcohol beverage until the Secretary has provided the Alcohol and Tobacco Tax and Trade Bureau with a reasonable opportunity to cease distribution and recall such article under the Alcohol and Tobacco Tax and Trade Bureau authority.
“(f) Cooperation and Consultation.–The Secretary shall work with State and local public health officials in carrying out this section, as appropriate.
“(g) Public Notification.–In conducting a recall under this section, the Secretary shall–
“(1) <<NOTE: Publication. Notices.>> ensure that a press release is published regarding the recall, as well as alerts and public notices, as appropriate, in order to provide notification–
“(A) of the recall to consumers and retailers to whom such article was, or may have been, distributed; and
“(B) that includes, at a minimum–
“(i) the name of the article of food subject to the recall;
“(ii) a description of the risk associated with such article; and
“(iii) to the extent practicable, information for consumers about similar articles of food that are not affected by the recall;
“(2) consult the policies of the Department of Agriculture regarding providing to the public a list of retail consignees receiving products involved in a Class I recall and shall consider providing such a list to the public, as determined appropriate by the Secretary; and
“(3) <<NOTE: Web posting.>> if available, publish on the Internet Web site of the Food and Drug Administration an image of the article that is the subject of the press release described in (1).
“(h) No Delegation.–The authority conferred by this section to order a recall or vacate a recall order shall not be delegated to any officer or employee other than the Commissioner.

  • [[Page 124 STAT. 3942]]

“(i) Effect.–Nothing in this section shall affect the authority of the Secretary to request or participate in a voluntary recall, or to issue an order to cease distribution or to recall under any other provision of this Act or under the Public Health Service Act.
“(j) Coordinated Communication.–
“(1) In general.–To assist in carrying out the requirements of this subsection, the Secretary shall establish an incident command operation or a similar operation within the Department of Health and Human Services that will operate not later than 24 hours after the initiation of a mandatory recall or the recall of an article of food for which the use of, or exposure to, such article will cause serious adverse health consequences or death to humans or animals.
(2) Requirements.–To reduce the potential for miscommunication during recalls or regarding investigations of a food borne illness outbreak associated with a food that is subject to a recall, each incident command operation or similar operation under paragraph (1) shall use regular staff and resources of the Department of Health and Human Services to–
“(A) ensure timely and coordinated communication within the Department, including enhanced communication and coordination between different agencies and organizations within the Department;
“(B) ensure timely and coordinated communication from the Department, including public statements, throughout the duration of the investigation and related foodborne illness outbreak;
“(C) identify a single point of contact within the Department for public inquiries regarding any actions by the Secretary related to a recall;
“(D) coordinate with Federal, State, local, and tribal authorities, as appropriate, that have responsibilities related to the recall of a food or a foodborne illness outbreak associated with a food that is subject to the recall, including notification of the Secretary of Agriculture and the Secretary of Education in the event such recalled food is a commodity intended for use in a child nutrition program (as identified in section 25(b) of the Richard B. Russell National School Lunch Act (42 U.S.C. 1769f(b))); and
“(E) conclude operations at such time as the Secretary determines appropriate.
“(3) Multiple recalls.–The Secretary may establish multiple or concurrent incident command operations or similar operations in the event of multiple recalls or foodborne illness outbreaks necessitating such action by the Department of Health and Human Services.”.
(b) Search Engine. <<NOTE: Deadline. Web posting. 21 USC 350l note.>> –Not later than 90 days after the date of enactment of this Act, the Secretary shall modify the Internet Web site of the Food and Drug Administration to include a search engine that–
(1) is consumer-friendly, as determined by the Secretary; and 
(2) provides a means by which an individual may locate relevant information regarding each article of food subject to a recall under section 423 of the Federal Food, Drug, and [[Page 124 STAT. 3943]] Cosmetic Act and the status of such recall (such as whether a recall is ongoing or has been completed).
(c) Civil Penalty.–Section 303(f)(2)(A) (21 U.S.C. 333(f)(2)(A)) is amended by inserting “or any person who does not comply with a recall order under section 423” after “section 402(a)(2)(B)”.
(d) Prohibited Acts.–Section 301 (21 U.S.C. 331 et seq.), as amended by section 106, is amended by adding at the end the following: “(xx) The refusal or failure to follow an order under section 423.”.
(e) GAO Review.–
(1) In general. <<NOTE: Deadline. Reports.>> –Not later than 90 days after the date of enactment of this Act, the Comptroller General of the United States shall submit to Congress a report that–
(A) identifies State and local agencies with the authority to require the mandatory recall of food, and evaluates use of such authority with regard to frequency, effectiveness, and appropriateness, including consideration of any new or existing mechanisms available to compensate persons for general and specific recall-related costs when a recall is subsequently determined by the relevant authority to have been an error;
(B) identifies Federal agencies, other than the Department of Health and Human Services, with mandatory recall authority and examines use of that authority with regard to frequency, effectiveness, and appropriateness, including any new or existing mechanisms available to compensate persons for general and specific recall- related costs when a recall is subsequently determined by the relevant agency to have been an error;
(C) considers models for farmer restitution implemented in other nations in cases of erroneous recalls; and
(D) makes recommendations to the Secretary regarding use of the authority under section 423 of the Federal Food, Drug, and Cosmetic Act (as added by this section) to protect the public health while seeking to minimize unnecessary economic costs.
(2) Effect of review. <<NOTE: Deadline. Study.>> –If the Comptroller General of the United States finds, after the review conducted under paragraph (1), that the mechanisms described in such paragraph do not exist or are inadequate, then, not later than 90 days after the conclusion of such review, the Secretary of Agriculture shall conduct a study of the feasibility of implementing a farmer indemnification program to provide restitution to agricultural producers for losses sustained as a result of a mandatory recall of an agricultural commodity by a Federal or State regulatory agency that is subsequently determined to be in error. <<NOTE: Reports.>> The Secretary of Agriculture shall submit to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a report that describes the results of the study, including any recommendations.
(f) <<NOTE: 21 USC 350l-1.>> Annual Report to Congress.–
(1) In general.–Not later than 2 years after the date of enactment of this Act and annually thereafter, the Secretary of Health and Human Services (referred to in this subsection as the “Secretary”) shall submit a report to the Committee [[Page 124 STAT. 3944]] on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on the use of recall authority under section 423 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)) and any public health advisories issued by the Secretary that advise against the consumption of an article of food on the ground that the article of food is adulterated and poses an imminent danger to health.
(2) Content.–The report under paragraph (1) shall include, with respect to the report year–
(A) the identity of each article of food that was the subject of a public health advisory described in paragraph (1), an opportunity to cease distribution and recall under subsection (a) of section 423 of the Federal Food, Drug, and Cosmetic Act, or a mandatory recall order under subsection (b) of such section;
(B) the number of responsible parties, as defined in section 417 of the Federal Food, Drug, and Cosmetic Act, formally given the opportunity to cease distribution of an article of food and recall such article, as described in section 423(a) of such Act;
(C) the number of responsible parties described in subparagraph (B) who did not cease distribution of or recall an article of food after given the opportunity to cease distribution or recall under section 423(a) of the Federal Food, Drug, and Cosmetic Act;
(D) the number of recall orders issued under section 423(b) of the Federal Food, Drug, and Cosmetic Act; and
(E) a description of any instances in which there was no testing that confirmed adulteration of an article of food that was the subject of a recall under section 423(b) of the Federal Food, Drug, and Cosmetic Act or a public health advisory described in paragraph (1).

Adulterated Food 21 US Code 342 -78(a)(1) Poisonous, insanitary, etc ingredients: if it bears or contains any poisonous (capable of causing death or illness if taken into the body) or deleterious (causing harm or damage) substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health.

(2)(a) if it bears or contains any added poisonous or added deleterious substance (other than a substance that is a pesticide chemical residue in or on a raw agricultural commodity or processed food, a food additive, a color additive, or a new animal drug) that is unsafe within the meaning of section 346 of this title…

(4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health…

(6) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s