National Residue Program: Monitoring Chemical Hazards, 81272-81276 [2015-32808]

Download as PDF 81272 Notices Federal Register Vol. 80, No. 249 Tuesday, December 29, 2015 This section of the FEDERAL REGISTER contains documents other than rules or proposed rules that are applicable to the public. Notices of hearings and investigations, committee meetings, agency decisions and rulings, delegations of authority, filing of petitions and applications and agency statements of organization and functions are examples of documents appearing in this section. DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service [Docket No. FSIS–2015–0002] National Residue Program: Monitoring Chemical Hazards Food Safety and Inspection Service, USDA. ACTION: Notice and request for comments. AGENCY: The Food Safety and Inspection Service (FSIS; also Agency) is clarifying its approach within the National Residue Program’s (NRP’s) Tier 2 exploratory program when it tests tissue samples collected from livestock and poultry carcasses and detects chemicals that do not have established tolerances or other regulatory levels. This approach applies to potentially hazardous chemicals that are not animal drugs or pesticide chemicals with established tolerances. The Agency also intends to apply this approach to egg products should these products become subject to chemical testing and to products from fish of the order Siluriformes when the final rule to make these species amenable to the Federal Meat Inspection Act (FMIA) is fully implemented. FSIS requests comments on the approach discussed in this document, and on how FSIS can further improve its management of environmental contaminants and other chemical hazards in meat and poultry products. SUMMARY: To receive full consideration, comments must be received on February 29, 2016. ADDRESSES: FSIS invites interested persons to submit comments on this notice. Comments may be submitted by one of the following methods: Federal eRulemaking Portal: This Web site provides the ability to type short comments directly into the comment field on this Web page or asabaliauskas on DSK5VPTVN1PROD with NOTICES DATES: VerDate Sep<11>2014 19:17 Dec 28, 2015 Jkt 238001 attach a file for lengthier comments. Go to http://www.regulations.gov. Follow the on-line instructions at that site for submitting comments. Mail, including CD–ROMs: Send to Docket Clerk, U.S. Department of Agriculture, Food Safety and Inspection Service, Patriots Plaza 3, 1400 Independence Avenue SW., Mailstop 3782, Room 8–163A, Washington, DC 20250–3700. Hand- or courier-delivered submittals: Deliver to Patriots Plaza 3, 355 E Street SW., Room 8–163A, Washington, DC 20250–3700. Instructions: All items submitted by mail or electronic mail must include the Agency name and docket number FSIS– 2015–0002. Comments received in response to this docket will be made available for public inspection and posted without change, including any personal information, to http:// www.regulations.gov. Docket: For access to background documents or comments received, go to the FSIS Docket Room at Patriot Plaza 3, 355 E Street SW., Room 8–164, Washington, DC 20250–3700 between 8:00 a.m. and 4:30 p.m., Monday through Friday. FOR FURTHER INFORMATION CONTACT: Dr. Patty Bennett, Humane Handling Enforcement Coordinator, Office of Field Operations, FSIS, USDA; Telephone (202)720–5397. SUPPLEMENTARY INFORMATION: Background To protect consumers and to verify the safety of meat, poultry, and egg products 1 in the United States, FSIS collects samples and analyzes them for a number of potentially harmful chemicals. Historically, the U.S. National Residue Program for Meat, Poultry, and Egg Products (NRP), administered by FSIS, has primarily monitored livestock and poultry carcasses for animal drugs and pesticide chemicals, which are regulated and approved for use by the Food and Drug 1 Products that meet USDA’s definition of ‘egg product’ are under USDA jurisdiction. The definition includes dried, frozen, or liquid eggs, with or without added ingredients, but mentions many exceptions. The following products, among others, are exempted as not being egg products: freeze-dried products, imitation egg products, egg substitutes. Products that do not fall under the definition, such as egg substitutes and cooked products, are under FDA jurisdiction. PO 00000 Frm 00001 Fmt 4703 Sfmt 4703 Administration (FDA) and the Environmental Protection Agency (EPA), respectively. However, in addition to animal drugs and pesticide chemicals, there are other chemicals, including metals, mycotoxins, dioxins, and other environmental and industrial contaminants, that may on occasion be found in FSIS-regulated products. The NRP systematically addresses animal drugs and pesticide chemicals, but it has not covered other chemicals in a structured manner. The fact that it has not done so led the USDA Office of the Inspector General (OIG) to recommend, in a March 2010 report on FSIS’s chemical residue program, that FSIS ‘‘establish policies and procedures for handling hazardous substances with no tolerances.’’ 2 While the OIG report concentrated on cattle, FSIS believes this concern applies to poultry and the other amenable livestock species (e.g., hogs, sheep) because issues associated with chemicals without a regulatory tolerance often are associated with sources that could involve more than one establishment and production class, such as contaminated feed. It is common practice for feed mills to produce feed for multiple species, and thus, a single contamination event may become an issue for several livestock and poultry production industries. In addition, FSIS does not limit testing for chemicals without tolerances to cattle. In a contamination event, the Agency would conduct testing on all exposed species. In this notice, FSIS is announcing that it has taken significant steps to enhance its ability to address all types of chemical hazards and is clarifying its approach within the NRP for addressing hazardous chemicals without established tolerances. Recent Improvements to the National Residue Program On July 6, 2012, FSIS announced that it was restructuring the NRP with respect to how samples are collected and analyzed for chemical compounds (New Analytical Methods and Sampling Procedures for the United States National Residue Program for Meat, Poultry, and Egg Products, 77 FR 39895). The new methods and 2 ‘‘FSIS National Residue Program for Cattle.’’ USDA, Office of the Inspector General Audit Report 24601–08–KC, March 2010. E:\FR\FM\29DEN1.SGM 29DEN1 asabaliauskas on DSK5VPTVN1PROD with NOTICES Federal Register / Vol. 80, No. 249 / Tuesday, December 29, 2015 / Notices procedures that FSIS has adopted have strengthened the NRP by making it into an integrated chemical hazard identification, prioritization, and management program that supports the Agency’s efforts to ensure that the U.S. supply of meat, poultry, and egg products is safe. FSIS has implemented new, more efficient analytical methods in its laboratories that enable the Agency to detect a greater number of chemicals than had been the case, and, at the same time, FSIS has streamlined its process for collecting samples for analysis. The restructured NRP consists of three tiers of sampling. Tier 1 is the scheduled sampling program that functions as an exposure assessment and includes sampling of both domestic and imported product. Production classes representing the majority of the annual volume of animals slaughtered in the United States (e.g., beef cows, market hogs, and young chickens) are tested under Tier 1. When a tissue sample from a livestock carcass is collected for residue testing under Tier 1, FSIS withholds the mark of inspection from the livestock carcass until all test results that bear on the determination as to whether the carcass is not adulterated have been received. On the other hand, poultry carcasses are not held pending test results (Not Applying the Mark of Inspection Pending Certain Test Results, 77 FR 73401, Dec. 10, 2012). Samples tested under Tier 1 are analyzed for a set of chemicals that currently includes animal drugs and pesticide chemicals. When any level of a chemical subject to Tier 1 testing is detected in a livestock carcass muscle sample, FSIS inspection program personnel are instructed to condemn the carcass and all parts, unless a tolerance level has been set for the chemical in the tissue and production class in question, and the detected level does not exceed this tolerance (Residue Sampling, Testing and Other Verification Procedures under the National Residue Program for Meat and Poultry Products, FSIS Directive 10,800.1). As mentioned above, poultry carcasses are generally not held pending the availability of test results, but any FSIS follow-up actions in response to violative results are the same for both poultry and livestock, including consultation with FDA and EPA. In recent years, egg products have not been a focus of the NRP. However, FSIS intends to apply the approach discussed in this notice to all FSIS-regulated products, including egg products, at which time egg products become subject to chemical testing. Thus, this notice VerDate Sep<11>2014 19:17 Dec 28, 2015 Jkt 238001 generally refers to ‘‘carcasses,’’ even though analogous actions may be taken with respect to FSIS-regulated egg products. Tier 2 testing encompasses two separate programs. The first, known as the inspector-generated program, is a targeted testing program in which field public health veterinarians (PHVs) decide to perform in-plant screens because they suspect that animals or carcasses contain higher than allowable levels of chemical residues. FSIS inspectors will collect and submit samples for inspector-generated residue testing if a screen test is positive, or if a PHV has reason to believe that a carcass or its parts may contain violative levels of one or more chemical residues, even if the screen test is negative (Residue Sampling, Testing and Other Verification Procedures under the National Residue Program, FSIS Directive 10,800.1, Rev. 1). The second, Tier 2 testing program, known as the exploratory assessment program, includes sampling plans designed in response to information gained from previous exposure assessments, from the chemical hazard identification process, or from other agencies. Unlike livestock carcasses selected for sampling under Tier 1 or under the inspector-generated program, carcasses selected for sampling under the exploratory assessment program can be released into commerce before exploratory sampling results are available. Essentially the exploratory assessment program is designed to investigate animal populations when the compounds in question have no established tolerances; respond to intelligence regarding use of veterinary drugs, pesticides, and environmental contaminants reported from the field; determine the prevalence and concentration of residues; and evaluate residue trends.3 FSIS uses the results from these exploratory assessments to identify potential chemical hazards of concern and to inform FSIS and NRP priorities. The exploratory assessment program includes testing for veterinary drugs, pesticides, and several metals.4 3 From: The United States National Residue Program (NRP) for Meat, Poultry and Egg Products: Residue Sampling Plans (traditionally known as the Blue Book), 2011 edition. At: http:// www.fsis.usda.gov/wps/portal/fsis/topics/datacollection-and-reports/chemistry/residue-chemistry. 4 For example, exploratory assessment program for 2015 found in Summary Table III in: The United States National Residue Program (NRP) for Meat, Poultry and Egg Products: Residue Sampling Plans (traditionally known as the Blue Book), 2015 edition. At: http://www.fsis.usda.gov/wps/portal/ fsis/topics/data-collection-and-reports/chemistry/ residue-chemistry. PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 81273 Tier 3 testing occurs in response to indications of chemical exposure to more than a single animal and encompasses targeted testing at the herd or flock level. Events triggering this type of testing are rare and usually involve extensive coordination between federal and state agencies at both the local and headquarters levels. This notice provides clarification to the Tier 2 exploratory assessment program. Current Regulatory Framework Under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.), and the Egg Products Inspection Act (EPIA) (21 U.S.C. 1031 et seq.), FSIS inspection personnel apply the mark of inspection to meat, poultry, and egg products only if they find upon inspection that these articles are not adulterated (21 U.S.C. 455, 457, 604, 606, 607, 1034, 1036). Under the Acts, meat, poultry, and egg products that do not bear an official mark of inspection are misbranded (21 U.S.C. 601(n)(12), 453(h)(12), and 1034). The Acts prohibit the sale or transportation in commerce of meat, poultry, and egg products capable of use as human food that are adulterated or misbranded or that have not been inspected and passed (21 U.S.C. 458(a)(2), 610(c), 1037(b)). Under the FMIA, ‘‘any carcass, part thereof, meat or meat food product’’ is adulterated ‘‘if it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in the case the substance is not an added substance, such article shall not be considered adulterated . . . if the quantity of such substance in or on such article does not ordinarily render it injurious to health’’ (21 U.S.C. 601(m)(1)). Under the FMIA, a product is also adulterated ‘‘if it bears or contains by reason of administration of any substance to the live animal or otherwise any added poisonous or added deleterious substance (other than one which is (i) a pesticide chemical in or on a raw agricultural commodity, (ii) a food additive, or (iii) a color additive) which may, in the judgment of the Secretary, make such article unfit for human food’’ (21 U.S.C. 601(m)(2)(A)). In addition, a product is adulterated under the FMIA if it bears or contains any pesticide chemical, color additives, or food additive that is unsafe within the meaning of the Federal Food, Drug, and Cosmetics Act (FFDCA) (21 U.S.C. 601(m)(2)(B)–(D)). Both the PPIA and EPIA contain similar provisions (21 U.S.C. 453(g)(1)–(2) and 1033(a)(1)–(2)). E:\FR\FM\29DEN1.SGM 29DEN1 81274 Federal Register / Vol. 80, No. 249 / Tuesday, December 29, 2015 / Notices asabaliauskas on DSK5VPTVN1PROD with NOTICES As mentioned above, because FSIS has primarily monitored livestock and poultry carcasses for animal drugs and pesticide chemicals, the approach described in this notice is initially intended to apply to livestock and poultry carcasses. FDA and EPA have statutory authority to establish residue tolerances that allow certain chemicals to remain in food products in nonharmful quantities, without causing these products to be adulterated. Under the FFDCA, the FDA may establish tolerances regulatory limits, and other limitations or specifications for animal drugs, approve food additives including conditions under which they may be used, and establish tolerances and regulatory limits for added or naturally occurring poisonous or deleterious substances, and the EPA may establish tolerance levels for registered pesticides. Title 21 of the Code of Federal Regulations (CFR) sets out tolerances and regulatory limits established by FDA, while Title 40 of the CFR sets out the tolerance levels established by EPA. In addition, FDA may also establish non-binding action levels that provide guidance for levels of contamination at which a food may be regarded as adulterated. Many of the tolerances and regulatory limits applicable to meat, poultry, or egg products have only been established for chemicals that are either animal drugs or pesticide chemicals. Yet other hazardous chemicals exist that do not have established tolerances, regulatory limits, or action levels but that could nonetheless be present in FSISregulated products at levels that may cause consumers to exceed a risk level for human consumption.5 6 This group of chemicals includes, but is not limited to, environmental contaminants, heavy metals, industrial chemicals, and mycotoxins. Unlike animal drugs or pesticide chemicals, these chemicals are usually not intentionally administered to food-producing animals or feed crops as part of accepted husbandry and agricultural practices. As such, they may not usually be reviewed by FDA or EPA as part of an approval process and hence may not have tolerances like animal drugs and pesticide chemicals and may not be subject to other regulatory limits. In most cases, the 5 For example, for lead and cadmium, see results at: The United States National Residue Program (NRP) for Meat, Poultry and Egg Products: Residue Sample Results (traditionally known as the Red Book), 2012 edition. At: http://www.fsis.usda.gov/ wps/portal/fsis/topics/data-collection-and-reports/ chemistry/residue-chemistry. 6 For example, for dioxin-like compounds, see results from FSIS dioxin surveys at: http:// www.fsis.usda.gov/wps/portal/fsis/topics/datacollection-and-reports/chemistry/residue-chemistry. VerDate Sep<11>2014 19:17 Dec 28, 2015 Jkt 238001 presence of these chemicals in edible animal tissue results from the foodproducing animal’s ante-mortem exposure to the chemical through feed, water, air, soil, or direct application. When a livestock or poultry carcass tested under the Tier 1 or the Tier 2 inspector-generated program is determined to contain a level of an animal drug or pesticide chemical that exceeds the applicable tolerance set by FDA or EPA, the carcass and parts are adulterated under the FMIA or PPIA and as such must be condemned.7 FSIS Directive 10,800.1 provides instructions to FSIS personnel on the disposition of carcasses containing violative residues and on other procedures related to residue sampling under the Tier 1 and inspector-generated programs. In contrast, although FSIS has detected, and continues to detect, environmental contaminants and other potential hazardous chemicals without established tolerances or regulatory levels through its exploratory assessment program, the Agency does not have a consistent and structured procedure for addressing these exploratory assessment results. Therefore, to better address the potential human health risks that may be associated with the presence of environmental contaminants and other potential chemical hazards without tolerances in meat and poultry products, FSIS is providing information regarding its approach to responding to findings from its exploratory sampling program. This information is intended to clarify how the Agency will respond to sampling results that reveal the presence of contaminants and chemicals of this type. FSIS is publishing this Federal Register document to inform the public of approach and to request public comments. Structured Approach for Chemicals Without Established Tolerances FSIS intends to proceed as follows when chemicals without established tolerances or other applicable regulatory levels are detected in livestock or poultry carcasses. For chemicals designated for testing in the Tier 2 exploratory assessment program, FSIS will derive a de minimis level (DML) for the chemical in samples collected from a given production class or species below which FSIS is confident that any public health concern is nonexistent or negligible (next section describes the derivation of the DML). If the 7 If there is no tolerance for an identified animal drug or pesticide subject to Tier 1 testing, carcasses or parts containing any amount of the substance are condemned. PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 concentrations of the chemical detected in Tier 2 exploratory testing are consistently at or below the DML, FSIS will likely discontinue the exploratory testing for that chemical. If, based on FSIS testing results, carcasses in Tier 2 testing are found to contain levels of a chemical above the de minimis level, FSIS will take certain actions, including notifying the slaughter or processing establishment or other affected entities, such as suppliers of the source animals, if needed, of the presence of the chemical and notifying the appropriate federal partners for possible trace-back investigations and consideration of potential mitigation actions. This approach is one that FSIS has historically taken on an ad hoc basis for chemical exposure incidents and in its dioxin surveys,8 and one that the Agency will continue to apply in this more structured approach for the exploratory chemicals in Tier 2 that are detected above the DML. Carcasses subject to Tier 2 exploratory sampling are typically not held pending the exploratory testing results. As discussed below, the Agency intends to assess levels of chemicals subject to exploratory sampling over time to evaluate the need to revise this policy. If the levels of the chemical are found to be above the DML on more than an occasional basis, FSIS will consider adding the chemical to the Tier 1 scheduled sampling program. FSIS will consult with the appropriate federal agency (FDA or EPA) regarding such an action and will issue a notice in the Federal Register to request public comments before placing such a chemical into Tier 1. If the chemical without a tolerance or other regulatory level is placed in Tier 1, FSIS will not apply the mark of inspection to livestock carcasses that have been sampled for testing until results at or under the DML are available and received for any testing conducted by the Agency. In the further absence of a tolerance or other regulatory level, the detection of any chemical levels over the DML would preclude FSIS from determining that the carcass or its parts are not adulterated. Deriving De Minimis Levels (DMLs) The DML is a concentration of the chemical in a particular edible tissue below which any risk to public health is negligible (de minimis risk). FSIS intends to use the DML as a guide to help ascertain whether a test result from the Tier 2 exploratory assessment 8 Dioxin survey procedures and results at: http:// www.fsis.usda.gov/wps/portal/fsis/topics/datacollection-and-reports/chemistry/residue-chemistry. E:\FR\FM\29DEN1.SGM 29DEN1 Federal Register / Vol. 80, No. 249 / Tuesday, December 29, 2015 / Notices asabaliauskas on DSK5VPTVN1PROD with NOTICES program needs follow-up actions or not. The derivation of a DML follows standard and routinely accepted risk assessment approaches.9 The DML is derived from a health-based guidance value for the given chemical, which is usually a human intake value (e.g., oral dose exposure) that is likely to be without an appreciable risk of deleterious effects during a lifetime, like a reference dose (RfD) or an acceptable daily intake (ADI). Health-based guidance values for many chemicals are published by agencies such as the EPA, the U.S. Agency for Toxic Substances and Disease Registry (ATSDR), and the Joint FAO/WHO Expert Committee on Food Additives (JECFA). If significant exposure routes other than meat or poultry products exist for the chemical hazard, an appropriate fraction of the health-based guidance value will be allocated to these other exposure routes. To arrive at the DML, the health-based guidance value—or the fraction thereof allocated to the meat or poultry products in question—will be used together with consumption estimates taken from the What We Eat in America (the dietary intake interview component of the National Health and Nutrition Examination Survey (NHANES)) or other appropriate consumption data.10 11 For almost all chemicals being considered for Tier 2 exploratory testing, a health-based guidance value exists, and the DML will be derived as described above. In the extremely rare instance where there is not a healthbased guidance value, FSIS will work its federal partners to decide on a course of action to develop one. In other instances however, a DML equivalent, such as a maximum level determination by the Codex Alimentarius, is available for specific chemicals in specific food commodities (e.g., for lead in meat of cattle, pigs and sheep).12 In these instances, FSIS will use such values as the DML. 9 For example, see: FAO/WHO (Food and Agriculture Organization of the United Nations/ World Health Organization). 2009. Environmental Health Criteria 240: Principles and methods for the risk assessment of chemicals in food. At: http:// www.who.int/ipcs/food/principles/en/index1.html. 10 http://www.cdc.gov/nchs/nhanes.htm. 11 Kerry L. Dearfield, Sarah R. Edwards, Margaret M. O’Keefe, Naser M. Abdelmajid, Ashley J. Blanchard, David D. Labarre, and Patty A. Bennett (U.S. Department of Agriculture, Food Safety and Inspection Service), ‘‘Dietary Estimates of Dioxins Consumed in U.S. Department of Agriculture— Regulated Meat and Poultry Products, ’’ Journal of Food Protection, 76, no. 9 (2013): 1597–1607. 12 Found in: Codex General Standard For Contaminants And Toxins In Food And Feed. At: http://www.codexalimentarius.org/standards/liststandards/en/?no_ cache=1?provide=standards&orderField= ccshort&sort=asc&num1=. VerDate Sep<11>2014 19:17 Dec 28, 2015 Jkt 238001 Identifying Chemicals of Concern FSIS may identify potential chemicals of concern for testing and the possible presence of chemical hazards in meat and poultry products through scientific literature reviews, expert elicitations, attendance at scientific meetings, collaboration with Federal, State, and international partners, and communication with stakeholders and trade partners. FSIS will also consult with its NRP collaboration body, the interagency Surveillance Advisory Team (SAT),13 for guidance on which chemicals to pursue in the Tier 2 exploratory program and for derivation of DMLs. Moreover, the multi-residue methods recently adopted by FSIS laboratories not only enable the Agency to test for a greater number of animal drug and pesticide chemical residues than in the past but also allow detection of a greater number of other potentially harmful chemicals, most of which do not have regulatory tolerances. As mentioned, FSIS has already been collecting data on certain environmental contaminants, including several metals, through its Tier 2 exploratory sampling. As a result of these efforts, FSIS may identify a chemical in meat or poultry products that is not being monitored by the Agency, and for which no applicable tolerance exists. In most such cases, FSIS will seek to empirically confirm the chemical’s presence in FSISregulated product through a Tier 2 exploratory assessment, which may be run for a period of time (e.g., one year) and will record baseline levels of the chemical. Cost-Benefit Analysis No significant costs to establishments, regardless of size, are expected as a result of the Tier 2 exploratory assessment program. The purpose of this sampling is to determine prevalence and levels of various hazardous chemicals in meat and poultry carcasses. Exploratory testing is being conducted under the NRP at little or no additional cost to the establishment or to the Agency. Once a DML is established, and FSIS is confident that these products are not adulterated based on the results from the exploratory 13 The Surveillance Advisory Team (SAT), is an interagency committee comprised of representatives from FSIS, FDA, EPA, AMS, ARS, and CDC. It consists of experts in veterinary medicine, toxicology, chemistry, and public health who provide professional advice, as well as information on veterinary drug and pesticide use in animal husbandry. The purpose of the SAT is to enhance communication, which includes obtaining and evaluating relevant toxicity and exposure information for each compound that supports the NRP. PO 00000 Frm 00004 Fmt 4703 Sfmt 4703 81275 testing, FSIS will then be able to limit the scope of this testing in the future. As mentioned, establishments will receive notification if any results of those tests are above the DML. There is no requirement for establishments to hold carcasses until acceptable results are available (as for Tier 1 and Tier 2 inspector-generated samples) under Tier 2 exploratory sampling, so there is no establishment cost associated with Tier 2 exploratory assessment program. In most instances, FSIS does not expect establishments to take significant mitigating actions as a result of Tier 2 exploratory sampling since the purpose of this sampling is to inform the Agency on general prevalence, and not the performance of a particular establishment. However, if an establishment has received multiple test results that are above the DML or if it receives a test result well above the DML, FSIS will consult and work with its federal, state and local partners to determine the cause of the positive test results at little or no additional expense to establishments. Once a cause has been discovered, the establishment may receive a letter from FSIS or its partner agencies (which could include any test results, possible leads of sources of contamination to evaluate, and provide opportunities to consult with the appropriate agencies), at which time the establishment may voluntarily choose to incur the additional costs of certain mitigating actions, such as discarding feed or replacing feed troughs. Given its experience under the dioxin survey program and the ongoing Tier 2 exploratory program for veterinary drugs and pesticides, FSIS expects these follow-up letters and mitigating actions to be a rare occurrence while products from an establishment are tested in the Tier 2 exploratory assessment program. If a chemical is moved into Tier 1 sampling, the Agency will inform the public and will conduct a cost-benefit analysis for the specific chemicals and products involved. The public will then have the opportunity to comment on the cost-benefit analysis. Request for Comments The approach discussed in this notice is intended to provide more structure and consistency for existing FSIS procedures and practices for addressing chemicals in livestock and poultry carcasses that do not have established tolerances or other regulatory levels. The approach is designed to cover most chemical hazards that do not derive from animal drugs or pesticide chemicals. As part of an integrated chemical hazard identification, prioritization, and management system E:\FR\FM\29DEN1.SGM 29DEN1 81276 Federal Register / Vol. 80, No. 249 / Tuesday, December 29, 2015 / Notices operating under the NRP, FSIS intends to use the risk-based procedures described in this document to efficiently and effectively address public health concerns associated with chemical hazards that may be detected in livestock and poultry carcasses. FSIS requests comments on the approach discussed in this document, and on how FSIS can further improve its management of environmental contaminants and other chemical hazards in meat and poultry products. USDA Non-Discrimination Statement No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/ parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination any person in the United States under any program or activity conducted by the USDA. asabaliauskas on DSK5VPTVN1PROD with NOTICES How to File a Complaint of Discrimination To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at: http:// www.ocio.usda.gov/sites/default/files/ docs/2012/Complain_combined_6_8_ 12.pdf, or write a letter signed by you or your authorized representative. Send your completed complaint form or letter to USDA by mail, fax, or email: Mail: U.S. Department of Agriculture, Director, Office of Adjudication, 1400 Independence Avenue SW., Washington, DC 20250–9410. Fax: (202) 690–7442. Email: program.intake@usda.gov. Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.), should contact USDA’s TARGET Center at (202) 720–2600 (voice and TDD). Additional Public Notification Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this Federal Register publication on-line through the FSIS Web page located at: http:// www.fsis.usda.gov/federal-register . FSIS also will make copies of this publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, and other types of information that could affect or would be of interest to our constituents and stakeholders. VerDate Sep<11>2014 19:17 Dec 28, 2015 Jkt 238001 The Update is available on the FSIS Web page. Through the Web page, FSIS is able to provide information to a much broader, more diverse audience. In addition, FSIS offers an email subscription service which provides automatic and customized access to selected food safety news and information. This service is available at: http://www.fsis.usda.gov/subscribe. Options range from recalls to export information, regulations, directives, and notices. Customers can add or delete subscriptions themselves, and have the option to password protect their accounts. Done in Washington, DC: December 18, 2015. Alfred V. Almanza, Acting Administrator. [FR Doc. 2015–32808 Filed 12–28–15; 8:45 am] BILLING CODE 3410–DM–P DEPARTMENT OF AGRICULTURE National Institute of Food and Agriculture Notice of Intent To Request Approval To Establish a New Information Collection and Record Keeping Requirement National Institute of Food and Agriculture, USDA. ACTION: Notice and request for comments. AGENCY: In accordance with the Paperwork Reduction Act of 1995 and Office of Management and Budget (OMB) regulations that implement the Paperwork Reduction Act of 1995, this notice announces the National Institute of Food and Agriculture’s (NIFA) intention to request approval to establish a new information collection and record keeping requirement for the Veterinary Medical Loan Repayment Program (VMLRP). DATES: Written comments on this notice must be received by February 29, 2016, to be assured of consideration. Comments received after that date will be considered to the extent practicable. ADDRESSES: Written comments may be submitted by any of the following methods: Email: rmartin@nifa.usda.gov; Mail: Office of Information Technology (OIT), NIFA, USDA, STOP 2216, 1400 Independence Avenue SW., Washington, DC 20250–2216. FOR FURTHER INFORMATION CONTACT: Robert Martin, Records Officer; Email: rmartin@nifa.usda.gov. SUPPLEMENTARY INFORMATION: Title: Veterinary Medical Loan Repayment Program (VMLRP). SUMMARY: PO 00000 Frm 00005 Fmt 4703 Sfmt 4703 OMB Number: 0524–New. Type of Request: Intent to request approval to establish a new information collection and record keeping requirement for three years. Abstract: In January 2003, the National Veterinary Medical Service Act (NVMSA) was passed into law adding section 1415A to the National Agricultural Research, Extension, and Teaching Policy Act of 1997. This law established a new Veterinary Medicine Loan Repayment Program (VMLRP) (7 U.S.C. 3125a) authorizing the Secretary of Agriculture to carry out a program of entering into agreements with veterinarians under which they agree to provide veterinary services in veterinarian shortage situations. The purpose of the program is to assure an adequate supply of trained food animal veterinarians in shortage situations and provide USDA with a pool of veterinary specialists to assist in the control and eradication of animal disease outbreaks. The VMLRP Program Office proposes a record keeping requirement for VMLRP participants and to collect additional information from current participants, their employers and past participants. The records to be maintained and the information collected will allow for better oversight and assessment of the program. Additionally, to streamline OMB approval processes all currently approved VMLRP information collections (OMB Control Number 0524–0046 and 0524–0047) will be combined into a single package along with the new information proposed. Each new requirement is described in detail below. (1) Service Log Need and Use of the Records: Program participants are required to verify on a quarterly basis that the terms of the VMLRP service agreement are being met through the Service Verification Form (NIFA–09–10, OMB No 0534–0047). This form is an affidavit signed by the program participant’s employer or, if self-employed, by the participant. Upon receipt by NIFA of a signed form affirming service under the terms and conditions of the service agreement, funds are released to participant’s lender(s). At this time the affidavit is not validated by VMLRP program staff. In order to validate service affidavits, the VMLRP proposes a recording keeping requirement for participants in the form of service log that would be subject to audit by program staff. During a service audit VMLRP staff will compare the service log to the shortage area description and contact participants with any questions. E:\FR\FM\29DEN1.SGM 29DEN1

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[Federal Register Volume 80, Number 249 (Tuesday, December 29, 2015)]
[Notices]
[Pages 81272-81276]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32808]


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Notices
                                                Federal Register
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This section of the FEDERAL REGISTER contains documents other than rules 
or proposed rules that are applicable to the public. Notices of hearings 
and investigations, committee meetings, agency decisions and rulings, 
delegations of authority, filing of petitions and applications and agency 
statements of organization and functions are examples of documents 
appearing in this section.

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Federal Register / Vol. 80, No. 249 / Tuesday, December 29, 2015 / 
Notices

[[Page 81272]]



DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2015-0002]


National Residue Program: Monitoring Chemical Hazards

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice and request for comments.

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SUMMARY: The Food Safety and Inspection Service (FSIS; also Agency) is 
clarifying its approach within the National Residue Program's (NRP's) 
Tier 2 exploratory program when it tests tissue samples collected from 
livestock and poultry carcasses and detects chemicals that do not have 
established tolerances or other regulatory levels. This approach 
applies to potentially hazardous chemicals that are not animal drugs or 
pesticide chemicals with established tolerances. The Agency also 
intends to apply this approach to egg products should these products 
become subject to chemical testing and to products from fish of the 
order Siluriformes when the final rule to make these species amenable 
to the Federal Meat Inspection Act (FMIA) is fully implemented. FSIS 
requests comments on the approach discussed in this document, and on 
how FSIS can further improve its management of environmental 
contaminants and other chemical hazards in meat and poultry products.

DATES: To receive full consideration, comments must be received on 
February 29, 2016.

ADDRESSES: FSIS invites interested persons to submit comments on this 
notice. Comments may be submitted by one of the following methods:
    Federal eRulemaking Portal: This Web site provides the ability to 
type short comments directly into the comment field on this Web page or 
attach a file for lengthier comments. Go to http://www.regulations.gov. 
Follow the on-line instructions at that site for submitting comments.
    Mail, including CD-ROMs: Send to Docket Clerk, U.S. Department of 
Agriculture, Food Safety and Inspection Service, Patriots Plaza 3, 1400 
Independence Avenue SW., Mailstop 3782, Room 8-163A, Washington, DC 
20250-3700.
    Hand- or courier-delivered submittals: Deliver to Patriots Plaza 3, 
355 E Street SW., Room 8-163A, Washington, DC 20250-3700.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2015-0002.
    Comments received in response to this docket will be made available 
for public inspection and posted without change, including any personal 
information, to http://www.regulations.gov.
    Docket: For access to background documents or comments received, go 
to the FSIS Docket Room at Patriot Plaza 3, 355 E Street SW., Room 8-
164, Washington, DC 20250-3700 between 8:00 a.m. and 4:30 p.m., Monday 
through Friday.

FOR FURTHER INFORMATION CONTACT: Dr. Patty Bennett, Humane Handling 
Enforcement Coordinator, Office of Field Operations, FSIS, USDA; 
Telephone (202)720-5397.

SUPPLEMENTARY INFORMATION: 

Background

    To protect consumers and to verify the safety of meat, poultry, and 
egg products \1\ in the United States, FSIS collects samples and 
analyzes them for a number of potentially harmful chemicals. 
Historically, the U.S. National Residue Program for Meat, Poultry, and 
Egg Products (NRP), administered by FSIS, has primarily monitored 
livestock and poultry carcasses for animal drugs and pesticide 
chemicals, which are regulated and approved for use by the Food and 
Drug Administration (FDA) and the Environmental Protection Agency 
(EPA), respectively.
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    \1\ Products that meet USDA's definition of `egg product' are 
under USDA jurisdiction. The definition includes dried, frozen, or 
liquid eggs, with or without added ingredients, but mentions many 
exceptions. The following products, among others, are exempted as 
not being egg products: freeze-dried products, imitation egg 
products, egg substitutes. Products that do not fall under the 
definition, such as egg substitutes and cooked products, are under 
FDA jurisdiction.
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    However, in addition to animal drugs and pesticide chemicals, there 
are other chemicals, including metals, mycotoxins, dioxins, and other 
environmental and industrial contaminants, that may on occasion be 
found in FSIS-regulated products. The NRP systematically addresses 
animal drugs and pesticide chemicals, but it has not covered other 
chemicals in a structured manner. The fact that it has not done so led 
the USDA Office of the Inspector General (OIG) to recommend, in a March 
2010 report on FSIS's chemical residue program, that FSIS ``establish 
policies and procedures for handling hazardous substances with no 
tolerances.'' \2\ While the OIG report concentrated on cattle, FSIS 
believes this concern applies to poultry and the other amenable 
livestock species (e.g., hogs, sheep) because issues associated with 
chemicals without a regulatory tolerance often are associated with 
sources that could involve more than one establishment and production 
class, such as contaminated feed. It is common practice for feed mills 
to produce feed for multiple species, and thus, a single contamination 
event may become an issue for several livestock and poultry production 
industries. In addition, FSIS does not limit testing for chemicals 
without tolerances to cattle. In a contamination event, the Agency 
would conduct testing on all exposed species.
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    \2\ ``FSIS National Residue Program for Cattle.'' USDA, Office 
of the Inspector General Audit Report 24601-08-KC, March 2010.
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    In this notice, FSIS is announcing that it has taken significant 
steps to enhance its ability to address all types of chemical hazards 
and is clarifying its approach within the NRP for addressing hazardous 
chemicals without established tolerances.

Recent Improvements to the National Residue Program

    On July 6, 2012, FSIS announced that it was restructuring the NRP 
with respect to how samples are collected and analyzed for chemical 
compounds (New Analytical Methods and Sampling Procedures for the 
United States National Residue Program for Meat, Poultry, and Egg 
Products, 77 FR 39895). The new methods and

[[Page 81273]]

procedures that FSIS has adopted have strengthened the NRP by making it 
into an integrated chemical hazard identification, prioritization, and 
management program that supports the Agency's efforts to ensure that 
the U.S. supply of meat, poultry, and egg products is safe. FSIS has 
implemented new, more efficient analytical methods in its laboratories 
that enable the Agency to detect a greater number of chemicals than had 
been the case, and, at the same time, FSIS has streamlined its process 
for collecting samples for analysis.
    The restructured NRP consists of three tiers of sampling. Tier 1 is 
the scheduled sampling program that functions as an exposure assessment 
and includes sampling of both domestic and imported product. Production 
classes representing the majority of the annual volume of animals 
slaughtered in the United States (e.g., beef cows, market hogs, and 
young chickens) are tested under Tier 1. When a tissue sample from a 
livestock carcass is collected for residue testing under Tier 1, FSIS 
withholds the mark of inspection from the livestock carcass until all 
test results that bear on the determination as to whether the carcass 
is not adulterated have been received. On the other hand, poultry 
carcasses are not held pending test results (Not Applying the Mark of 
Inspection Pending Certain Test Results, 77 FR 73401, Dec. 10, 2012).
    Samples tested under Tier 1 are analyzed for a set of chemicals 
that currently includes animal drugs and pesticide chemicals. When any 
level of a chemical subject to Tier 1 testing is detected in a 
livestock carcass muscle sample, FSIS inspection program personnel are 
instructed to condemn the carcass and all parts, unless a tolerance 
level has been set for the chemical in the tissue and production class 
in question, and the detected level does not exceed this tolerance 
(Residue Sampling, Testing and Other Verification Procedures under the 
National Residue Program for Meat and Poultry Products, FSIS Directive 
10,800.1). As mentioned above, poultry carcasses are generally not held 
pending the availability of test results, but any FSIS follow-up 
actions in response to violative results are the same for both poultry 
and livestock, including consultation with FDA and EPA. In recent 
years, egg products have not been a focus of the NRP. However, FSIS 
intends to apply the approach discussed in this notice to all FSIS-
regulated products, including egg products, at which time egg products 
become subject to chemical testing. Thus, this notice generally refers 
to ``carcasses,'' even though analogous actions may be taken with 
respect to FSIS-regulated egg products.
    Tier 2 testing encompasses two separate programs. The first, known 
as the inspector-generated program, is a targeted testing program in 
which field public health veterinarians (PHVs) decide to perform in-
plant screens because they suspect that animals or carcasses contain 
higher than allowable levels of chemical residues. FSIS inspectors will 
collect and submit samples for inspector-generated residue testing if a 
screen test is positive, or if a PHV has reason to believe that a 
carcass or its parts may contain violative levels of one or more 
chemical residues, even if the screen test is negative (Residue 
Sampling, Testing and Other Verification Procedures under the National 
Residue Program, FSIS Directive 10,800.1, Rev. 1).
    The second, Tier 2 testing program, known as the exploratory 
assessment program, includes sampling plans designed in response to 
information gained from previous exposure assessments, from the 
chemical hazard identification process, or from other agencies. Unlike 
livestock carcasses selected for sampling under Tier 1 or under the 
inspector-generated program, carcasses selected for sampling under the 
exploratory assessment program can be released into commerce before 
exploratory sampling results are available. Essentially the exploratory 
assessment program is designed to investigate animal populations when 
the compounds in question have no established tolerances; respond to 
intelligence regarding use of veterinary drugs, pesticides, and 
environmental contaminants reported from the field; determine the 
prevalence and concentration of residues; and evaluate residue 
trends.\3\ FSIS uses the results from these exploratory assessments to 
identify potential chemical hazards of concern and to inform FSIS and 
NRP priorities. The exploratory assessment program includes testing for 
veterinary drugs, pesticides, and several metals.\4\
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    \3\ From: The United States National Residue Program (NRP) for 
Meat, Poultry and Egg Products: Residue Sampling Plans 
(traditionally known as the Blue Book), 2011 edition. At: http://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/chemistry/residue-chemistry.
    \4\ For example, exploratory assessment program for 2015 found 
in Summary Table III in: The United States National Residue Program 
(NRP) for Meat, Poultry and Egg Products: Residue Sampling Plans 
(traditionally known as the Blue Book), 2015 edition. At: http://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/chemistry/residue-chemistry.
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    Tier 3 testing occurs in response to indications of chemical 
exposure to more than a single animal and encompasses targeted testing 
at the herd or flock level. Events triggering this type of testing are 
rare and usually involve extensive coordination between federal and 
state agencies at both the local and headquarters levels.
    This notice provides clarification to the Tier 2 exploratory 
assessment program.

Current Regulatory Framework

    Under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et 
seq.), the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et 
seq.), and the Egg Products Inspection Act (EPIA) (21 U.S.C. 1031 et 
seq.), FSIS inspection personnel apply the mark of inspection to meat, 
poultry, and egg products only if they find upon inspection that these 
articles are not adulterated (21 U.S.C. 455, 457, 604, 606, 607, 1034, 
1036). Under the Acts, meat, poultry, and egg products that do not bear 
an official mark of inspection are misbranded (21 U.S.C. 601(n)(12), 
453(h)(12), and 1034). The Acts prohibit the sale or transportation in 
commerce of meat, poultry, and egg products capable of use as human 
food that are adulterated or misbranded or that have not been inspected 
and passed (21 U.S.C. 458(a)(2), 610(c), 1037(b)).
    Under the FMIA, ``any carcass, part thereof, meat or meat food 
product'' is adulterated ``if it bears or contains any poisonous or 
deleterious substance which may render it injurious to health; but in 
the case the substance is not an added substance, such article shall 
not be considered adulterated . . . if the quantity of such substance 
in or on such article does not ordinarily render it injurious to 
health'' (21 U.S.C. 601(m)(1)). Under the FMIA, a product is also 
adulterated ``if it bears or contains by reason of administration of 
any substance to the live animal or otherwise any added poisonous or 
added deleterious substance (other than one which is (i) a pesticide 
chemical in or on a raw agricultural commodity, (ii) a food additive, 
or (iii) a color additive) which may, in the judgment of the Secretary, 
make such article unfit for human food'' (21 U.S.C. 601(m)(2)(A)). In 
addition, a product is adulterated under the FMIA if it bears or 
contains any pesticide chemical, color additives, or food additive that 
is unsafe within the meaning of the Federal Food, Drug, and Cosmetics 
Act (FFDCA) (21 U.S.C. 601(m)(2)(B)-(D)). Both the PPIA and EPIA 
contain similar provisions (21 U.S.C. 453(g)(1)-(2) and 1033(a)(1)-
(2)).

[[Page 81274]]

    As mentioned above, because FSIS has primarily monitored livestock 
and poultry carcasses for animal drugs and pesticide chemicals, the 
approach described in this notice is initially intended to apply to 
livestock and poultry carcasses. FDA and EPA have statutory authority 
to establish residue tolerances that allow certain chemicals to remain 
in food products in non-harmful quantities, without causing these 
products to be adulterated. Under the FFDCA, the FDA may establish 
tolerances regulatory limits, and other limitations or specifications 
for animal drugs, approve food additives including conditions under 
which they may be used, and establish tolerances and regulatory limits 
for added or naturally occurring poisonous or deleterious substances, 
and the EPA may establish tolerance levels for registered pesticides. 
Title 21 of the Code of Federal Regulations (CFR) sets out tolerances 
and regulatory limits established by FDA, while Title 40 of the CFR 
sets out the tolerance levels established by EPA. In addition, FDA may 
also establish non-binding action levels that provide guidance for 
levels of contamination at which a food may be regarded as adulterated.
    Many of the tolerances and regulatory limits applicable to meat, 
poultry, or egg products have only been established for chemicals that 
are either animal drugs or pesticide chemicals. Yet other hazardous 
chemicals exist that do not have established tolerances, regulatory 
limits, or action levels but that could nonetheless be present in FSIS-
regulated products at levels that may cause consumers to exceed a risk 
level for human consumption.5 6 This group of chemicals 
includes, but is not limited to, environmental contaminants, heavy 
metals, industrial chemicals, and mycotoxins. Unlike animal drugs or 
pesticide chemicals, these chemicals are usually not intentionally 
administered to food-producing animals or feed crops as part of 
accepted husbandry and agricultural practices. As such, they may not 
usually be reviewed by FDA or EPA as part of an approval process and 
hence may not have tolerances like animal drugs and pesticide chemicals 
and may not be subject to other regulatory limits. In most cases, the 
presence of these chemicals in edible animal tissue results from the 
food-producing animal's ante-mortem exposure to the chemical through 
feed, water, air, soil, or direct application.
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    \5\ For example, for lead and cadmium, see results at: The 
United States National Residue Program (NRP) for Meat, Poultry and 
Egg Products: Residue Sample Results (traditionally known as the Red 
Book), 2012 edition. At: http://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/chemistry/residue-chemistry.
    \6\ For example, for dioxin-like compounds, see results from 
FSIS dioxin surveys at: http://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/chemistry/residue-chemistry.
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    When a livestock or poultry carcass tested under the Tier 1 or the 
Tier 2 inspector-generated program is determined to contain a level of 
an animal drug or pesticide chemical that exceeds the applicable 
tolerance set by FDA or EPA, the carcass and parts are adulterated 
under the FMIA or PPIA and as such must be condemned.\7\ FSIS Directive 
10,800.1 provides instructions to FSIS personnel on the disposition of 
carcasses containing violative residues and on other procedures related 
to residue sampling under the Tier 1 and inspector-generated programs.
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    \7\ If there is no tolerance for an identified animal drug or 
pesticide subject to Tier 1 testing, carcasses or parts containing 
any amount of the substance are condemned.
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    In contrast, although FSIS has detected, and continues to detect, 
environmental contaminants and other potential hazardous chemicals 
without established tolerances or regulatory levels through its 
exploratory assessment program, the Agency does not have a consistent 
and structured procedure for addressing these exploratory assessment 
results. Therefore, to better address the potential human health risks 
that may be associated with the presence of environmental contaminants 
and other potential chemical hazards without tolerances in meat and 
poultry products, FSIS is providing information regarding its approach 
to responding to findings from its exploratory sampling program. This 
information is intended to clarify how the Agency will respond to 
sampling results that reveal the presence of contaminants and chemicals 
of this type. FSIS is publishing this Federal Register document to 
inform the public of approach and to request public comments.

Structured Approach for Chemicals Without Established Tolerances

    FSIS intends to proceed as follows when chemicals without 
established tolerances or other applicable regulatory levels are 
detected in livestock or poultry carcasses. For chemicals designated 
for testing in the Tier 2 exploratory assessment program, FSIS will 
derive a de minimis level (DML) for the chemical in samples collected 
from a given production class or species below which FSIS is confident 
that any public health concern is nonexistent or negligible (next 
section describes the derivation of the DML). If the concentrations of 
the chemical detected in Tier 2 exploratory testing are consistently at 
or below the DML, FSIS will likely discontinue the exploratory testing 
for that chemical.
    If, based on FSIS testing results, carcasses in Tier 2 testing are 
found to contain levels of a chemical above the de minimis level, FSIS 
will take certain actions, including notifying the slaughter or 
processing establishment or other affected entities, such as suppliers 
of the source animals, if needed, of the presence of the chemical and 
notifying the appropriate federal partners for possible trace-back 
investigations and consideration of potential mitigation actions. This 
approach is one that FSIS has historically taken on an ad hoc basis for 
chemical exposure incidents and in its dioxin surveys,\8\ and one that 
the Agency will continue to apply in this more structured approach for 
the exploratory chemicals in Tier 2 that are detected above the DML. 
Carcasses subject to Tier 2 exploratory sampling are typically not held 
pending the exploratory testing results. As discussed below, the Agency 
intends to assess levels of chemicals subject to exploratory sampling 
over time to evaluate the need to revise this policy.
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    \8\ Dioxin survey procedures and results at: http://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/chemistry/residue-chemistry.
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    If the levels of the chemical are found to be above the DML on more 
than an occasional basis, FSIS will consider adding the chemical to the 
Tier 1 scheduled sampling program. FSIS will consult with the 
appropriate federal agency (FDA or EPA) regarding such an action and 
will issue a notice in the Federal Register to request public comments 
before placing such a chemical into Tier 1. If the chemical without a 
tolerance or other regulatory level is placed in Tier 1, FSIS will not 
apply the mark of inspection to livestock carcasses that have been 
sampled for testing until results at or under the DML are available and 
received for any testing conducted by the Agency. In the further 
absence of a tolerance or other regulatory level, the detection of any 
chemical levels over the DML would preclude FSIS from determining that 
the carcass or its parts are not adulterated.

Deriving De Minimis Levels (DMLs)

    The DML is a concentration of the chemical in a particular edible 
tissue below which any risk to public health is negligible (de minimis 
risk). FSIS intends to use the DML as a guide to help ascertain whether 
a test result from the Tier 2 exploratory assessment

[[Page 81275]]

program needs follow-up actions or not. The derivation of a DML follows 
standard and routinely accepted risk assessment approaches.\9\ The DML 
is derived from a health-based guidance value for the given chemical, 
which is usually a human intake value (e.g., oral dose exposure) that 
is likely to be without an appreciable risk of deleterious effects 
during a lifetime, like a reference dose (RfD) or an acceptable daily 
intake (ADI). Health-based guidance values for many chemicals are 
published by agencies such as the EPA, the U.S. Agency for Toxic 
Substances and Disease Registry (ATSDR), and the Joint FAO/WHO Expert 
Committee on Food Additives (JECFA). If significant exposure routes 
other than meat or poultry products exist for the chemical hazard, an 
appropriate fraction of the health-based guidance value will be 
allocated to these other exposure routes. To arrive at the DML, the 
health-based guidance value--or the fraction thereof allocated to the 
meat or poultry products in question--will be used together with 
consumption estimates taken from the What We Eat in America (the 
dietary intake interview component of the National Health and Nutrition 
Examination Survey (NHANES)) or other appropriate consumption 
data.10 11
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    \9\ For example, see: FAO/WHO (Food and Agriculture Organization 
of the United Nations/World Health Organization). 2009. 
Environmental Health Criteria 240: Principles and methods for the 
risk assessment of chemicals in food. At: http://www.who.int/ipcs/food/principles/en/index1.html.
    \10\ http://www.cdc.gov/nchs/nhanes.htm.
    \11\ Kerry L. Dearfield, Sarah R. Edwards, Margaret M. O'Keefe, 
Naser M. Abdelmajid, Ashley J. Blanchard, David D. Labarre, and 
Patty A. Bennett (U.S. Department of Agriculture, Food Safety and 
Inspection Service), ``Dietary Estimates of Dioxins Consumed in U.S. 
Department of Agriculture--Regulated Meat and Poultry Products, '' 
Journal of Food Protection, 76, no. 9 (2013): 1597-1607.
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    For almost all chemicals being considered for Tier 2 exploratory 
testing, a health-based guidance value exists, and the DML will be 
derived as described above. In the extremely rare instance where there 
is not a health-based guidance value, FSIS will work its federal 
partners to decide on a course of action to develop one. In other 
instances however, a DML equivalent, such as a maximum level 
determination by the Codex Alimentarius, is available for specific 
chemicals in specific food commodities (e.g., for lead in meat of 
cattle, pigs and sheep).\12\ In these instances, FSIS will use such 
values as the DML.
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    \12\ Found in: Codex General Standard For Contaminants And 
Toxins In Food And Feed. At: http://www.codexalimentarius.org/standards/list-standards/en/?no_cache=1?provide=standards&orderField=ccshort&sort=asc&num1=.
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Identifying Chemicals of Concern

    FSIS may identify potential chemicals of concern for testing and 
the possible presence of chemical hazards in meat and poultry products 
through scientific literature reviews, expert elicitations, attendance 
at scientific meetings, collaboration with Federal, State, and 
international partners, and communication with stakeholders and trade 
partners. FSIS will also consult with its NRP collaboration body, the 
interagency Surveillance Advisory Team (SAT),\13\ for guidance on which 
chemicals to pursue in the Tier 2 exploratory program and for 
derivation of DMLs.
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    \13\ The Surveillance Advisory Team (SAT), is an interagency 
committee comprised of representatives from FSIS, FDA, EPA, AMS, 
ARS, and CDC. It consists of experts in veterinary medicine, 
toxicology, chemistry, and public health who provide professional 
advice, as well as information on veterinary drug and pesticide use 
in animal husbandry. The purpose of the SAT is to enhance 
communication, which includes obtaining and evaluating relevant 
toxicity and exposure information for each compound that supports 
the NRP.
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    Moreover, the multi-residue methods recently adopted by FSIS 
laboratories not only enable the Agency to test for a greater number of 
animal drug and pesticide chemical residues than in the past but also 
allow detection of a greater number of other potentially harmful 
chemicals, most of which do not have regulatory tolerances. As 
mentioned, FSIS has already been collecting data on certain 
environmental contaminants, including several metals, through its Tier 
2 exploratory sampling.
    As a result of these efforts, FSIS may identify a chemical in meat 
or poultry products that is not being monitored by the Agency, and for 
which no applicable tolerance exists. In most such cases, FSIS will 
seek to empirically confirm the chemical's presence in FSIS-regulated 
product through a Tier 2 exploratory assessment, which may be run for a 
period of time (e.g., one year) and will record baseline levels of the 
chemical.

Cost-Benefit Analysis

    No significant costs to establishments, regardless of size, are 
expected as a result of the Tier 2 exploratory assessment program. The 
purpose of this sampling is to determine prevalence and levels of 
various hazardous chemicals in meat and poultry carcasses. Exploratory 
testing is being conducted under the NRP at little or no additional 
cost to the establishment or to the Agency. Once a DML is established, 
and FSIS is confident that these products are not adulterated based on 
the results from the exploratory testing, FSIS will then be able to 
limit the scope of this testing in the future. As mentioned, 
establishments will receive notification if any results of those tests 
are above the DML. There is no requirement for establishments to hold 
carcasses until acceptable results are available (as for Tier 1 and 
Tier 2 inspector-generated samples) under Tier 2 exploratory sampling, 
so there is no establishment cost associated with Tier 2 exploratory 
assessment program.
    In most instances, FSIS does not expect establishments to take 
significant mitigating actions as a result of Tier 2 exploratory 
sampling since the purpose of this sampling is to inform the Agency on 
general prevalence, and not the performance of a particular 
establishment. However, if an establishment has received multiple test 
results that are above the DML or if it receives a test result well 
above the DML, FSIS will consult and work with its federal, state and 
local partners to determine the cause of the positive test results at 
little or no additional expense to establishments. Once a cause has 
been discovered, the establishment may receive a letter from FSIS or 
its partner agencies (which could include any test results, possible 
leads of sources of contamination to evaluate, and provide 
opportunities to consult with the appropriate agencies), at which time 
the establishment may voluntarily choose to incur the additional costs 
of certain mitigating actions, such as discarding feed or replacing 
feed troughs. Given its experience under the dioxin survey program and 
the ongoing Tier 2 exploratory program for veterinary drugs and 
pesticides, FSIS expects these follow-up letters and mitigating actions 
to be a rare occurrence while products from an establishment are tested 
in the Tier 2 exploratory assessment program.
    If a chemical is moved into Tier 1 sampling, the Agency will inform 
the public and will conduct a cost-benefit analysis for the specific 
chemicals and products involved. The public will then have the 
opportunity to comment on the cost-benefit analysis.

Request for Comments

    The approach discussed in this notice is intended to provide more 
structure and consistency for existing FSIS procedures and practices 
for addressing chemicals in livestock and poultry carcasses that do not 
have established tolerances or other regulatory levels. The approach is 
designed to cover most chemical hazards that do not derive from animal 
drugs or pesticide chemicals. As part of an integrated chemical hazard 
identification, prioritization, and management system

[[Page 81276]]

operating under the NRP, FSIS intends to use the risk-based procedures 
described in this document to efficiently and effectively address 
public health concerns associated with chemical hazards that may be 
detected in livestock and poultry carcasses. FSIS requests comments on 
the approach discussed in this document, and on how FSIS can further 
improve its management of environmental contaminants and other chemical 
hazards in meat and poultry products.

USDA Non-Discrimination Statement

    No agency, officer, or employee of the USDA shall, on the grounds 
of race, color, national origin, religion, sex, gender identity, sexual 
orientation, disability, age, marital status, family/parental status, 
income derived from a public assistance program, or political beliefs, 
exclude from participation in, deny the benefits of, or subject to 
discrimination any person in the United States under any program or 
activity conducted by the USDA.

How to File a Complaint of Discrimination

    To file a complaint of discrimination, complete the USDA Program 
Discrimination Complaint Form, which may be accessed online at: http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your 
authorized representative.
    Send your completed complaint form or letter to USDA by mail, fax, 
or email:
    Mail: U.S. Department of Agriculture, Director, Office of 
Adjudication, 1400 Independence Avenue SW., Washington, DC 20250-9410.
    Fax: (202) 690-7442.
    Email: program.intake@usda.gov.
    Persons with disabilities who require alternative means for 
communication (Braille, large print, audiotape, etc.), should contact 
USDA's TARGET Center at (202) 720-2600 (voice and TDD).

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication on-line through the FSIS Web page located at: 
http://www.fsis.usda.gov/federal-register .
    FSIS also will make copies of this publication available through 
the FSIS Constituent Update, which is used to provide information 
regarding FSIS policies, procedures, regulations, Federal Register 
notices, FSIS public meetings, and other types of information that 
could affect or would be of interest to our constituents and 
stakeholders. The Update is available on the FSIS Web page. Through the 
Web page, FSIS is able to provide information to a much broader, more 
diverse audience. In addition, FSIS offers an email subscription 
service which provides automatic and customized access to selected food 
safety news and information. This service is available at: http://www.fsis.usda.gov/subscribe. Options range from recalls to export 
information, regulations, directives, and notices. Customers can add or 
delete subscriptions themselves, and have the option to password 
protect their accounts.

    Done in Washington, DC: December 18, 2015.
Alfred V. Almanza,
Acting Administrator.
[FR Doc. 2015-32808 Filed 12-28-15; 8:45 am]
 BILLING CODE 3410-DM-P