The Federal Tort Claims Act (FTCA), as amended, 28 U.S.C. 2671-2680, and the regulations issued by the Department of Justice (DOJ) contained in 28 CFR part 14, authorize the head of the Bureau or designee to consider, ascertain, adjust, determine, compromise, and settle claims for money damages against the United States for personal injury, death, or property loss or damage caused by the negligent or wrongful act or omission of any employee of the Bureau while acting within the scope of the employee's office or employment, under circumstances where the United States, if it were a private person, would be liable, in accordance with the law of the place where the act or omission occurred. This rule (Final Rule) establishes the Bureau's procedures for filing and processing any such claims.

Under the Final Rule, a claimant may present a covered claim to the Bureau by submitting a completed claim form and appropriate supporting information and evidence to the Bureau's General Counsel. The Final Rule authorizes the Bureau's General Counsel and members of the Legal Division designated by the General Counsel to consider and attempt to resolve claims. If the General Counsel or the General Counsel's designee disallows a claim, the General Counsel or designee will notify the claimant in writing.

This Final Rule is issued under the FTCA, as amended, which authorizes the Attorney General to prescribe regulations for the administrative adjustment of claims by Federal agencies. 28 U.S.C. 2672. The Attorney General, in turn, has authorized each Federal agency to issue regulations and establish procedures consistent with 28 CFR part 14. 28 CFR 14.11.

The Final Rule is procedural and not substantive and, thus, is not subject to the 30-day delay in effective date required by 5 U.S.C. 553(d). The Bureau is making the Final Rule effective immediately upon publication in the Federal Register .

The Final Rule constitutes a Bureau rule of organization, procedure, or practice that is exempt from notice and public comment pursuant to 5 U.S.C. 553(b). Because notice of proposed rulemaking is not required, the Final Rule is not a “rule” as defined by the Regulatory Flexibility Act and the provisions of that statute do not apply. 5 U.S.C. 601(2). The Final Rule does not contain any new or revised information collection requirements that require the approval of the Office of Management and Budget (OMB) under the Paperwork Reduction Act. 44 U.S.C. 3501 et seq. The U.S. Department of Justice has previously obtained OMB approval for the Standard Form 95 and it is assigned the OMB control number 1105-0008. Please note that, notwithstanding any other provision of law, the Bureau may not conduct and persons are not required to respond to a collection of information unless it displays a currently valid OMB control number.

For the reasons set forth above, the CFPB amends Chapter X in Title 12 of the Code of Federal Regulations by adding a new part 1076 to read as follows:

In FR Doc. 2013-12242 appearing on page 33476 in the Federal Register of Tuesday, June 4, 2013, the following corrections are made:

Need for the rule: Celiac disease is a hereditary, chronic inflammatory disorder of the small intestine triggered by the ingestion of certain storage proteins referred to as gluten occurring in wheat, rye, barley, and crossbreeds of these grains. Celiac disease has no cure, but individuals who have this disease are advised to avoid all sources of gluten in their diet to protect against adverse health effects associated with the disease. Many manufacturers currently label their food with a “gluten-free” labeling claim. However, there is no current regulatory definition for the ”gluten-free” claim in the United States. Establishing in this final rule a regulatory definition of the food labeling term “gluten-free” and uniform conditions for its use in the labeling of foods is necessary to ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled; this final rule is also necessary to respond to a directive of FALCPA (title II of Pub. L. 108-282).

Legal authority: Consistent with section 206 of FALCPA and sections 403(a)(1), 201(n), and 701(a) of the FD&C Act (21 U.S.C. 343(a)(1), 321(n), and 371(a), respectively), we are issuing requirements for the use of the term “gluten free” for voluntary use in the labeling of foods.

The final rule defines and sets conditions on the use of the term “gluten-free” in foods, including:

• Foods that inherently do not contain gluten (e.g., raw carrots or grapefruit juice) may use the “gluten-free” claim.

• Foods with any whole, gluten-containing grains (e.g., spelt wheat) as ingredients may not use the claim;

• Foods with ingredients that are gluten-containing grains that are refined but still contain gluten (e.g., wheat flour) may not use the claim;

• Foods with ingredients that are gluten-containing grains that have been refined in such a way to remove the gluten may use the claim, so long as the food contains less than 20 ppm gluten/has less than 20 mg gluten per kg (e.g. wheat starch);

• Foods may not use the claim if they contain 20 ppm or more gluten as a result of cross-contact with gluten containing grains.

For reasons discussed in more detail in this document, under limited circumstances we intend to exercise enforcement discretion with respect to the requirements for “gluten-free” labeling for FDA-regulated beers that currently make a “gluten-free” claim and that are: (1) Made from a non-gluten-containing grain or (2) made from a gluten-containing grain, where the beer has been subject to processing that the manufacturer has determined will remove gluten below a 20 ppm threshold. We plan to issue a proposed rule to address our compliance approach to fermented or hydrolyzed products.

In addition, the final rule provides that:

• A food that bears the claim “no gluten,” “free of gluten,” or “without gluten” in its labeling and fails to meet the requirements for a “gluten-free” claim will be deemed to be misbranded.

• A food whose labeling includes the term “wheat” in the ingredient list or in a separate “Contains wheat” statement as required by FALCPA and also bears the claim “gluten-free” will be deemed to be misbranded unless its labeling also bears additional language clarifying that the wheat has been processed to allow the food to meet FDA requirements for a “gluten-free” claim.

By defining “gluten-free” and the conditions under which a “gluten-free” claim can be used, the final rule makes it easier for individuals with celiac disease to make informed purchasing decisions. This will enable them to adhere to a diet they can tolerate without causing adverse health effects and to select from a variety of available gluten-free foods.

Full compliance with the final rule would have annualized costs of about $7 million per year and annual health benefits of about $110 million per year:

Celiac disease (also known as celiac sprue and gluten-sensitive enteropathy) is a chronic inflammatory disorder of the small intestine in genetically susceptible individuals. It is triggered by ingesting certain storage proteins, commonly referred to as “gluten,” that naturally occur in some cereal grains (Refs. 1 through 3). In such individuals, the consumption of gluten stimulates the production of antibodies and inflammatory cells, resulting in an abnormal immune response, which damages the tiny, fingerlike protrusions called “villi,” that line the small intestine and function to absorb nutrients from food (Ref. 4). Over time, continued dietary exposure to gluten can destroy the intestinal villi of individuals with celiac disease, leading to a lack of absorption of nutrients and a wide variety of other serious health problems (Ref. 4).

The symptoms and clinical manifestations of celiac disease are highly variable among affected individuals and differ in severity. The reasons for this variability are unknown, but may depend upon the individual's age and immunological status, the amount, duration or timing of the exposure to gluten, and the specific area and extent of the gastrointestinal tract involved in the disease (Ref. 5). Symptoms of celiac disease may be: (1) “Classical,” affecting the digestive tract (e.g., abdominal bloating; cramping and pain; chronic diarrhea; vomiting; constipation) and resulting in gastrointestinal malabsorption; or (2) “atypical,” affecting mainly other parts of the body (e.g., fatigue; irritability; behavior changes; bone or joint pain; tingling numbness in the legs; ulcers in the mouth; tooth discoloration or loss of enamel; itchy skin rash with blisters called dermatitis herpetiformis) (Refs. 1, 4, 6, and 7).

A large portion of the subpopulation that has celiac disease may not experience any symptoms at all, and these individuals are classified as having either the “silent” or “latent” form of celiac disease (Refs. 1 and 8). Persons who have the silent form of celiac disease have most of the diagnostic features commonly seen in individuals with classical or atypical celiac disease, such as specific serum antibodies and evidence of damaged intestinal villi. Those who have the latent form of celiac disease have specific serum antibodies, but no evidence of damaged intestinal villi (Ref. 1).

In addition to the aforementioned clinical symptoms and ailments, celiac disease is associated with a number of significant health problems and disorders, including iron-deficiency anemia, vitamin deficiencies, protein-calorie malnutrition, weight loss, short stature, growth retardation in children, delayed puberty, infertility, miscarriage, and osteoporosis (Refs. 1, 6, 9, and 10). Individuals with unmanaged celiac disease are at an increased risk of developing other serious medical conditions, such as Type I diabetes mellitus, intestinal cancers, and both intestinal and extraintestinal non-Hodgkin's lymphomas (Refs. 7, 11, 12, and 13).

Celiac disease has no cure, but individuals who have this disease are advised to avoid all sources of gluten in their diet (Refs. 1 and 6). Over time, strictly avoiding consumption of gluten can resolve the symptoms, mitigate and possibly reverse the damage, and reduce the associated health risks of celiac disease (Ref. 14). For some individuals with celiac disease, failure to avoid consumption of gluten can lead to severe and sometimes life-threatening complications that can affect multiple organs of the body (Refs. 5, 6, and 15).

Precise prevalence data for celiac disease are not available. In the January 23, 2007, proposed rule (72 FR 2795 at 2797), we cited estimates regarding the overall prevalence of celiac disease in the United States ranging from about 0.4 percent to about 1 percent of the general population, or approximately 1.5 to 3 million Americans (Refs. 1 and 16). According to the National Health and Nutrition Examination Survey (NHANES) 2009-2010 survey data on medical conditions, 0.14 percent of the civilian, non-institutionalized population of the United States reported having been told by a medical professional that they have celiac disease (Ref. 17). Researchers examining serological data from a subset of the NHANES 2009-2010 study population for evidence of celiac disease estimated the prevalence of celiac disease at 0.71 percent (Ref. 18).

The discrepancy between estimated prevalence and diagnosed cases has been linked primarily to the fact that celiac disease can be silent or latent, as described in section I.A. Silent and latent forms of celiac disease may go undetected in an individual for years before the person develops symptoms causing him or her to seek medical attention. In addition, celiac disease is often mistaken for other gastrointestinal malabsorption disorders that have similar diarrheal symptoms (e.g., irritable bowel syndrome), which further delays its diagnosis (Ref. 19). Only recently has the medical community become more aware of the need to screen for celiac disease when patients experience health problems that may be associated with the disease or when patients have family members, especially first- and second-degree relatives, who have celiac disease (Ref. 1).

FALCPA, Title II of Public Law 108-282, was enacted on August 2, 2004. Section 206 of FALCPA directs the Secretary of Health and Human Services (HHS) (the Secretary), in consultation with appropriate experts and stakeholders, to issue a rule to define, and permit use of, the term “gluten-free” on the labeling of foods. This rulemaking implements section 206 of FALCPA.

FALCPA does not require that we establish a threshold level for gluten. Nonetheless, an important scientific issue associated with the issuance of this rule is the potential existence of a threshold level below which it is unlikely that an individual with celiac disease will have an adverse health effect.

To address this issue, among others, we established an internal, interdisciplinary group (the Threshold Working Group) to review the scientific literature on the issue of a threshold level for gluten. The Threshold Working Group's report, “Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food” (issued in draft and later revised, referred to herein as the “Thresholds Report” except where noted) (Ref. 20), summarized the current state of scientific knowledge with respect to a dose-response relationship for gluten, and presented the following four potential approaches that we might consider in establishing such a threshold level, if we chose to do so (Ref. 20, pp. 2 and 38-41; Ref. 21 at pp. 2 and 42-45):

• Analytical methods-based—thresholds are determined by the sensitivity of the analytical method(s) used to verify compliance.

• Safety assessment-based—“safe” level is calculated using the No Observed Adverse Effect Level (NOAEL) from available human challenge studies, applying an appropriate “uncertainty factor” multiplier to account for knowledge gaps.

• Risk assessment-based—examines known or potential adverse health effects resulting from human exposure to a hazard; quantifies the levels of risk associated with specific exposures and the degree of uncertainty inherent in the risk estimate.

• Statutorily derived—uses an exemption articulated in an applicable law and extrapolates from that to other potentially similar situations.

As the Thresholds Report explained, the term “threshold” has multiple meanings, including toxicological and statutory (or regulatory) (see Ref. 20 at p. 10). The Threshold Working Group noted that “[u]nderstanding thresholds for gluten will help FDA develop a definition of ‘gluten-free' and identify appropriate uses of the term.” The Threshold Working Group recognized that setting such a regulatory threshold likely would require consideration of additional factors not addressed in the Thresholds Report, such as ease of compliance and enforcement, concerns of stakeholders (i.e., industry, consumers, and other interested parties), economics (e.g., cost/benefit analysis), trade issues, and legal authorities (Ref. 20 at p. 41).

The Thresholds Report concluded that it was not possible for us to use the quantitative risk assessment-based approach due to the lack of sufficient data from human clinical trials and the lack of sufficient data on exposure, and that the statutorily derived approach is not viable in the absence of applicable statutory provisions (Ref. 20 at pp. 4, 60, and 61). Thus, the two approaches identified in that report as viable for establishing a threshold for gluten were the analytical methods-based approach and the safety assessment-based approach.

In the Federal Register of June 17, 2005 (70 FR 35258), we published a notice announcing the availability of the draft version of the Thresholds Report. We invited interested persons to submit comments and any scientific data or other information to the docket during a 60-day comment period that ended on August 16, 2005. The Threshold Working Group considered the comments, data, and information submitted, and made appropriate revisions to the draft Thresholds Report. On May 25, 2006, we posted our response (Ref. 22) to the comments, data, and other information that we received. We also posted the revised Thresholds Report (Ref. 21). Both documents are dated March 2006.

Additionally, in the Federal Register of May 23, 2005 (70 FR 29528), we announced that our Food Advisory Committee (FAC) would hold a public meeting on July 13 through 15, 2005, to evaluate the draft version of the Thresholds Report. One purpose of the meeting was for the FAC to determine whether the four approaches considered in the Thresholds Report for establishing a threshold level for gluten were scientifically sound. We invited experts to address a number of specific issues related to sensitivities to gluten. In addition, we invited interested persons to submit comments and any scientific data or other information relevant to the issues pending before the FAC.

During the public meeting, the FAC heard presentations from invited experts on the diagnosis and treatment of celiac disease, the quality of life issues faced by those who have celiac disease and their families, the relationship between gluten proteins in various grains and celiac disease, analytical methods for detecting and measuring the levels of gluten in food, the value and use of prospective and retrospective gluten tolerance studies, and a summary of existing national and international definitions of “gluten-free” for food labeling. Further, members of the general public, including those representing trade associations, industry, consumers, and other stakeholders, gave brief presentations before the FAC to share their perspectives on some of the same topics addressed by the invited experts. The speaker presentations, public comments, FAC discussions, and the FAC responses to a set of specific questions and the charge to the FAC posed by FDA's Center for Food Safety and Applied Nutrition (CFSAN) are recorded in the transcript of the meeting, which is available through the FDA Docket No. 2005N-0231 and is posted at CFSAN's Web site ( http://www.fda.gov/ohrms/dockets/ac/cfsan05.html ). Copies of the transcript materials that specifically address the topics of celiac disease and a gluten threshold level are also available through the docket for this rulemaking. A summary of the FAC responses to the questions is provided in the Summary Minutes (Ref. 23).

The FAC concluded that the Thresholds Report “includes a comprehensive evaluation of the currently available data and descriptions of all relevant approaches that could be used to establish [a] threshold . . . for gluten in food” (Ref. 23, p. 1). The FAC also identified the risk-assessment approach as the strongest of the four approaches proposed in the Thresholds Report, assuming the availability of sufficient data (Ref. 23, p. 1).

In the Federal Register of July 19, 2005 (70 FR 41356), we announced that we would hold a public meeting on August 19, 2005, to discuss the topic of gluten-free food labeling. We gave interested persons until September 19, 2005, to comment on a list of specific questions concerning food manufacturing, analytical methods, and consumer purchasing practices and views about gluten-free foods (70 FR 41356 at 41357). In addition, we invited experts to address these issues at the meeting, and invited members of the general public, including individuals with celiac disease and their caregivers, to share their views about foods produced and labeled as “gluten-free.” We received more than 2,400 comments about the public meeting or the list of questions cited in the notice announcing the meeting. The vast majority of these comments were from individuals with celiac disease, their caregivers, and celiac disease associations; we also received comments from the food industry. Most consumers said that they appreciate and use “gluten-free” labeling claims to identify packaged foods they can eat when trying to avoid gluten. Many consumers stated that a “gluten-free” labeling claim makes it easier to shop for groceries, saving the consumers both time and the frustration experienced when reading often lengthy and complicated ingredients lists that the consumers did not understand. Many consumers also stated that they primarily purchase packaged foods bearing a “gluten-free” labeling claim and that a standardized definition of the term “gluten-free” for foods marketed in the United States would give them more assurance that foods bearing this claim are appropriate for individuals trying to avoid gluten. The comments reflected a consensus of opinion among individuals with celiac disease, and the organizations which represent them, that wheat, rye, and barley should be excluded from any products labeled as “gluten-free.” However, comments from these individuals and organizations varied with respect to whether we should exclude oats from any products labeled as “gluten-free.”

Industry comments submitted in response to the 2005 public meeting or to the list of questions cited in the notice announcing the meeting indicated that currently there is no universal understanding among manufacturers of what the term “gluten-free” means and there is no uniform industry standard for producing foods bearing this labeling claim. Several industry comments expressed the opinion that a standardized definition for “gluten-free” could help promote fair competition among packaged foods marketed as gluten-free in the United States, because all manufacturers would have to adhere to the same requirements if they label their products “gluten-free.”

In the Federal Register of January 23, 2007 (72 FR 2795), we published a proposed rule to define the term “gluten-free” and allow its voluntary use in the labeling of foods. In brief, the proposed rule would:

• Define the term “gluten-free” for voluntary use in the labeling of foods, to mean that the food does not contain any of the following: An ingredient that is any species of the grains wheat, rye, barley, or a crossbred hybrid of these grains (collectively referred to in the proposed rule as “prohibited grains”); an ingredient that is derived from a prohibited grain and that has not been processed to remove gluten (e.g., wheat flour); an ingredient that is derived from a prohibited grain and that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 ppm or more gluten in the food; or 20 ppm or more gluten.

• Deem a food to be misbranded that bears the claim “gluten-free” or similar claim in its labeling and fails to meet the conditions specified in the proposed definition of “gluten-free.”

• Deem a food to be misbranded if it bears a “gluten-free” claim in its labeling if the food is inherently free of gluten and if the claim does not refer to all foods of that same type (e.g., “milk, a gluten-free food” or “all milk is gluten-free”).

• Deem a food made from oats that bears a “gluten-free” claim in its labeling to be misbranded if the claim suggests that all such foods are “gluten-free” or if 20 ppm or more gluten is present in the food.

The proposed rule would create a new § 101.91 entitled “Gluten-free labeling of food.” In the preamble to the proposed rule (72 FR 2795 at 2803), we stated that, after publication of the proposed rule, we would conduct a safety assessment for gluten exposure consistent with the safety assessment-based approach described in the Thresholds Report. We requested comments providing data relevant to the safety assessment. We stated that we would publish a notice in the Federal Register seeking comment on the draft safety assessment and its potential use in the final rule and that we would consider public and peer-review comments in revising the safety assessment, as appropriate. Under the safety assessment-based approach, the labeling threshold would be determined at least in part on the basis of a “safe” level or “tolerable daily intake” (TDI) of a substance as calculated using the NOAELs and the Lowest Observed Adverse Effect Levels from available dose-response data in animals or humans and applying one or more appropriate “uncertainty factors” to account for gaps, limitations, and uncertainty in the data and for inter-individual difference (i.e., variability among individuals within the target population).

We subsequently completed a health hazard assessment of the adverse health effects of gluten exposure in individuals with celiac disease that included a safety assessment for gluten, and we submitted a report on this health hazard assessment, the “Gluten Report,” to scientific experts for peer review. In the preamble to this final rule, we generally use the term “safety assessment” to mean the entire analysis reported in the “Gluten Report”, because this language is consistent with the Thresholds Report's use of the term “safety assessment-based approach.” We revised the “Gluten Report” after considering the experts' comments and made a report concerning the peer review available at our Web site at http://www.fda.gov/downloads/Food/ScienceResearch/ResearchAreas/RiskAssessmentSafetyAssessment/UCM264152.pdf.

In the Federal Register of August 3, 2011 (76 FR 46671), we published a notice (2011 notice) that reopened the comment period for the proposed rule, in part, to announce the availability of the “Gluten Report” and to invite comments on the report. We also asked whether and if so, how, the safety assessment should affect FDA's proposed definition of “gluten-free” in the final rule. Finally, we sought comment on our tentative conclusion that the safety assessment-based approach may lead to a conservative, highly uncertain estimation of risk to individuals with celiac disease associated with very low levels of gluten exposure, and that the final rule should adopt the proposed rule's approach to defining the term “gluten-free.” We also sought comment on a few other matters unrelated to the questions about the safety assessment and its potential use in the final rule.

We received a number of comments concerning our safety assessment. To the extent those comments address the potential use of the safety assessment in the final rule, we describe and respond to them in part II. We discuss and respond to comments that focused on the safety assessment's methodology in “FDA's Responses to Comments on the Report Titled ‘Health Hazard Assessment for Gluten Exposure in Individuals With Celiac Disease: Determination of Tolerable Daily Intake Levels and Levels of Concern for Gluten,' ” (Ref. 24) which is available at http://www.fda.gov/downloads/Food/FoodScienceResearch/RiskSafetyAssessment/UCM362401.pdf. We received nearly 2,000 submissions in response to both the proposed rule and to the 2011 notice announcing the reopening of the comment period. Most submissions came from individuals, and we also received comments from industry and trade associations, consumer and advocacy groups, academic organizations, and foreign government agencies. For example, many comments from consumers stated that they currently must search the list of ingredients on each product and that it is difficult to do so because the presence of gluten is not always evident to a layperson from the information on the label. Some comments noted that consumers often contact the manufacturer to confirm if the food contains gluten and that this task requires significant time and effort. The comments stated that foods labeled “gluten-free” according to a standard definition would provide an easier and faster way to identify such foods. Despite the apparent broad consensus among comments about the need for a standard definition of “gluten-free,” the comments raised many distinct issues about how such a definition should be developed and implemented.

We discuss the issues raised in the comments on the proposed rule as well as the 2011 notice, and also describe the final rule, in section II. For ease of reading, we preface each comment discussion with a numbered “Comment,” and each response by a corresponding numbered “Response.” We have numbered each comment to help distinguish among different topics. The number assigned is for organizational purposes only and does not signify the comment's value, importance, or the order in which it was received.

As explained in sections I.C and I.D, the Thresholds Report summarized the current state of scientific knowledge with respect to a dose-response relationship for gluten, and presented four potential approaches that we might consider in establishing such a threshold level. We decided to issue a proposed rule that used one of those approaches, an analytical methods-based approach, under which the thresholds are determined by the sensitivity of the analytical method(s) used to verify compliance. However, we also conducted a safety assessment in which we reviewed available human challenge studies, exposure data, and other information, applying certain specified assumptions and appropriate “uncertainty factor” multipliers to account for knowledge gaps, to arrive at an estimation of risk to individuals with celiac disease associated with very low levels of gluten exposure. In the safety assessment we estimated level of concern (LOC) values for individuals with celiac disease, depending upon the corresponding age group and whether the adverse health effects are clinical or morphological and/or physiological in nature, at the 90th percentile level of intake of “all celiac disease grain foods.” As described in the “Gluten Report,” the estimated gluten LOC values for individuals with celiac disease range from 0.01 to 0.06 ppm. However, as we noted in the 2011 notice, this estimation of risk to individuals with celiac disease associated with very low levels of gluten exposure may be conservative and highly uncertain.

Many comments supported our tentative conclusion to use the analytical method-based approach, rather than the safety assessment-based approach, and supported our proposed criteria for defining the term “gluten-free,” including the proposed requirement that food bearing a “gluten-free” claim not contain 20 ppm or more gluten. Some comments argued that the safety assessment-based approach should be followed. The comments on our approach raised four primary points concerning which approach to use in the final rule, addressed in more detail in the following bulleted list. These were:

• The potential impact of the choice of approach on the availability of foods that could be labeled “gluten-free”;

• The potential impact on the health of individuals with celiac disease of the choice of approach for establishing a regulatory definition of “gluten-free”;

• The availability of analytical methods to evaluate compliance and to enforce a regulatory definition of “gluten-free” at different levels; and

• The relationship between FDA's definition of “gluten-free” and that of international bodies.

(Comment 1) Several comments stated that using an extremely low level of gluten, such as those estimated in the safety assessment, to define “gluten-free” could cause some manufacturers to stop identifying food as gluten-free. The comments explained that, under the safety assessment-based approach, a manufacturer might stop identifying a food as gluten-free because the food could not meet a very low gluten threshold (e.g., 0.01 ppm gluten) for reasons such as an ingredient's cross-contact with gluten-containing grain during agricultural production or supply stages or difficulty separating gluten-containing and gluten-free products in mixed-use processing facilities.

Many comments from individuals with celiac disease stated that they rely on products labeled “gluten-free” to reduce the time spent reading ingredient lists on products to determine if the foods are safe for them to eat. These comments expressed concern that if we establish a gluten content that is lower than < 20 ppm gluten for purposes of defining the term “gluten-free,” manufacturers might find it difficult to manufacture foods that consistently met the lower gluten content. The comments stated that this may result in fewer foods labeled “gluten-free.” The comments suggested that a decrease in the number and variety of foods labeled “gluten-free” would mean that individuals with celiac disease would have to invest more time and effort to identify appropriate foods, and could reduce compliance with a gluten-free diet, with potential adverse health consequences for them.

One comment stated that, even if an analytical method were available to test for the presence of gluten at levels below 1 ppm, “it would become increasingly costly for food companies, despite thorough adherence to good manufacturing practices, either to clean equipment adequately or to invest in dedicated equipment in order to meet the increasingly lower gluten threshold. This in turn would lead to more expensive food products developed for celiac consumers, or to companies stopping the production of ‘gluten free' food products, thus reducing the food choices available for gluten sensitive consumers.” Other comments echoed that the result of adopting the safety assessment-based approach would be more costly food or fewer food options for individuals who have celiac disease.

(Response 1) We agree with the comments that the food industry may be unable to consistently meet a standard limiting the presence of gluten in foods labeled “gluten-free” to < 1 ppm, and that such a low level cannot, as of the date of this final rule, be verified through scientifically valid analytical methods. We also agree that such an approach would result in the removal from the market of many products that currently meet the criterion of < 20 ppm gluten in the definition of “gluten-free” and bear the claim, or discourage the introduction of new foods labeled as “gluten-free,” because manufacturers could not meet a gluten limit much lower than < 20 ppm. Limiting the availability of the number and variety of foods labeled “gluten-free” would be detrimental to individuals with celiac disease who are already challenged by the complexities of adhering long term to a gluten-free diet.

As for the comment's claim that an analytical method to detect very low gluten levels would be cost prohibitive, in the absence of such methods, we decline to speculate about their cost and whether manufacturers would be willing to incur such costs.

(Comment 2) Several comments indicated that consumers are uncertain about how much gluten 20 ppm represents and its relevance to the total amount of gluten that most individuals with celiac disease can tolerate.

(Response 2) Twenty ppm gluten is a concentration level rather than an absolute quantity of gluten in a food. Twenty ppm is the same as 0.002 percent. For example, at a concentration level of 20 ppm gluten, a 28.35 gram (g) or 1-ounce portion of food would contain 0.567 mg gluten (20 mg/kg × 28.35 g × 1 kg/1000 g = 0.567 mg). Because 20 ppm refers to a concentration and not an absolute quantity of gluten, if the ingredients of a food are all below 20 ppm, the end product cannot have a concentration that exceeds 20 ppm. The amount of gluten to which a person with celiac disease would be exposed in consuming food labeled “gluten-free” would depend upon the total quantity/weight of food consumed and the actual concentration of gluten in the product. On our own initiative, we have revised the final rule to describe the equivalent concentration of 20 mg gluten per kg of food to further harmonize our rule with international standards, such as those used in Codex Standard 118-1979 and European Commission Regulation No 41/2009.

(Comment 3) Several comments supported the proposed < 20 ppm gluten level as a criterion for labeling food as “gluten-free.” The comments asserted that individuals with celiac disease have for many years been consuming food products with levels of 20 ppm or more without adverse effect, and that products whose gluten levels are < 20 ppm should be safe for most individuals with celiac disease. The comments did not provide data to support these assertions.

Other comments expressed the belief that adopting a gluten level well below 20 ppm would reduce the risk of adverse health outcomes that individuals with celiac disease might experience at the proposed level of < 20 ppm gluten.

(Response 3) The final rule adopts a gluten content of < 20 ppm for parts of the definition of the “gluten-free” labeling claim, using the analytical methods-based approach. The scientific research conducted thus far and the information presented in our Gluten Report support a conclusion that most individuals with celiac disease can tolerate food that contains variable trace amounts and concentrations of gluten (see 76 FR 46671 at 46674 through 46675).

As we stated in the 2011 notice: “To the extent it is possible to do so and protect public health, we believe that we should set a gluten threshold level for ‘gluten free' labeling that best assists most individuals with celiac disease in adhering life-long to a ‘gluten-free' diet without causing adverse health consequences. If the prevalence of persons with celiac disease not following a ‘gluten-free' diet increases because there are fewer foods labeled ‘gluten-free' to choose from (because the criteria for making ‘gluten-free' labeling claims are too stringent for most food manufacturers to meet) or such foods become more expensive (because any changes made by manufacturers to enable them to meet more stringent criteria to make foods labeled ‘gluten-free' may increase their production costs), then these individuals could be at a higher risk of developing serious health complications and other diseases associated with celiac disease. In other words, moving to a definition of ‘gluten-free' that adopts a criterion that is much lower than < 20 ppm gluten could have an adverse impact on the health of Americans with celiac disease.” (See 76 FR 46671 at 46675).

Thus, while we disagree with the comments to the extent that they suggest that there is clear evidence that individuals with celiac disease have been consuming food with gluten content at or above 20 ppm without adverse effect, we believe that the available data and information support a determination that retaining the < 20 ppm part of the criteria for defining “gluten-free” is protective of public health.

For similar reasons, we also disagree with the comments suggesting that adopting a gluten level well below 20 ppm would reduce the risks of adverse health outcomes for individuals with celiac disease. Although the safety assessment estimated that highly sensitive individuals with celiac disease may not be fully protected if they consume foods containing a trace level of gluten above 0.01 ppm but below 20 ppm (see 76 FR 46671 at 46675), statements by some celiac disease researchers, based on their experience and epidemiological evidence, suggest that variable trace amounts and concentrations of gluten in foods can be tolerated by most individuals with celiac disease without causing adverse health effects (id. at 46674-46675). Thus, revising the proposed threshold gluten content for defining “gluten-free” to lower than 20 ppm (as per the safety assessment results) would not offer additional protection or clinical benefits to individuals with celiac disease. Moreover, other comments about the methodology used and studies chosen in the safety assessment suggest that the conclusions based on this information have led to highly conservative tolerance estimates for gluten. As such, although clearly defined gluten thresholds cannot be determined at this time of this final rule, there is no evidence that consumption of food products containing less than 20 ppm gluten would pose a risk of adverse health effects for the large majority of individuals with celiac disease. Future research and improved data on defining gluten thresholds may lead us to revisit our conclusion.

The varying needs of individuals with celiac disease may be best addressed by focused education and outreach. We acknowledge the offers of assistance we received in comments from several health care professionals, celiac disease organizations, and others to provide educational materials and conduct seminars that may help individuals to fully understand how the labeling can be used in their adherence to a gluten-free diet.

Although many comments focused on the < 20 ppm part of the criteria, under the final rule there are other criteria for when a food can and cannot be labeled “gluten-free.” These other criteria also are intended to reduce exposure to gluten in products labeled “gluten-free.” In essence, the definition of “gluten-free” is structured in such a way that manufacturers who wish to use a “gluten-free” claim cannot use as ingredients in their foods gluten-containing grains, or ingredients derived from those grains that have not been processed to remove gluten, regardless of the ultimate presence of gluten in the food.

Finally, we note that some comments indicated that some manufacturers of foods that may contain gluten—either because they contain ingredients that have been processed to remove gluten but retain some amount of gluten, or due to cross-contact—are able to produce foods that contain well below 20 ppm gluten, through the selection of ingredients, the use of facilities dedicated to only producing gluten-free foods, and the use of additional specific manufacturing controls that can prevent gluten cross-contact situations. We encourage the development and implementation of manufacturing practices that will ensure foods bearing the claim “gluten-free” meet the requirements in this final rule.

(Comment 4) One comment asserted that the results of the safety assessment demonstrate that there is no specific level of gluten that typically produces an adverse response in those sensitive to gluten and supported FDA's proposed approach as protective of most people with celiac disease based on currently available data and methodologies. The comment suggested that, if the proposed approach is used, manufacturers of products bearing a “gluten-free” claim also should be required to disclose the products' actual gluten content level (in mg per serving) on the label. The comment explained that disclosing the products' actual gluten content level will help individuals determine if a product is appropriate for their individual health needs and better control their gluten consumption. The comment also stated that, if the final rule adopts a < 20 ppm gluten limit, we should amend it quickly as new data become available concerning gluten tolerance or analytical methods.

(Response 4) We agree that the research described in the safety assessment and other data suggest that there is considerable human variability in response (in both kind and degree) to dietary gluten, and we took this inter-individual variability into account in the safety assessment by using a multiplier of 10 as one of the 2 uncertainty factors used to reduce the estimated TDI gluten levels. However, because of this variability and other uncertainties, as we noted in the 2011 notice, the safety assessment-based approach would lead to a conservative, highly uncertain estimate of risk to individuals with celiac disease associated with very low levels of gluten exposure. We also agree with the comment that we will need to continue to evaluate newer scientific knowledge and clinical findings, particularly on the long-term needs of those with celiac disease, and scientifically valid analytical methods for quantifying lower gluten content, as they become available. If those findings change our consideration of the various factors that we have applied in this rulemaking, we may, as suggested by the comment, consider reviewing the standard for “gluten-free” labeling. In the meantime, we encourage manufacturers of gluten-free foods to produce such foods with as little gluten as possible and to continue research in processing methods to reduce levels further.

We disagree with the comment's suggestion that we require manufacturers of gluten-free products to disclose their products' actual gluten content level on the labels. First, requiring a gluten-free product's label to disclose the product's actual gluten content level would be impractical because there might be variability in gluten content of a particular food due to natural variation in ingredients, minor modifications in the food's formulation, or changes in other manufacturing practices. Manufacturers also might change ingredient suppliers to reduce their manufacturing costs or buy ingredients from different suppliers if a particular ingredient were in short supply; in these situations, the gluten content of an ingredient also might change. Thus, if we were to require manufacturers to disclose a product's actual gluten content, we would, in effect, be requiring manufacturers to test each batch of a food product that is already eligible to bear a “gluten-free” claim (e.g., did not contain 20 ppm or more gluten) and to reprint labels any time there was a slight variation in the gluten content of that food. This requirement would discourage manufacturers from marketing foods with a “gluten-free” label, and this, in turn, would limit the availability and variety of gluten-free foods for individuals with celiac disease.

Second, 20 ppm is currently the lowest level at which analytical methods have been scientifically validated to reliably and consistently detect gluten across a range of food matrices. Therefore, we are not in a position to identify a specific analytical method that a firm could use to identify the actual level of gluten in a food below 20 ppm.

We are aware that some independent third-party organizations currently certify products with respect to their gluten content, and that manufacturers of gluten-free products that obtain such certification may currently include information regarding the certified status of their products on their labels. We will evaluate such labeling to ensure such information is truthful and not misleading and meets other applicable FDA requirements.

(Comment 5) Some comments stated that there is no analytical method to measure gluten at the levels identified in the safety assessment (0.01 to 0.6 ppm).

(Response 5) We agree with the comments that it is currently not possible to reliably and consistently test for gluten at the very low levels identified in the safety assessment. There are methods with limits of detection that are lower than the level at which they have been validated. Thus far, the reliability of those methods at these lower limits has not been demonstrated. Twenty ppm remains the level of gluten that can reliably and consistently be detected in a variety of food matrices.

(Comment 6) Numerous comments concurred with the proposed level of < 20 ppm as among the criteria for a “gluten-free” definition based on the analytical methods-based approach, but stated that we should reduce the gluten content used as part of the criteria to define the term “gluten-free” when validated analytical methods become available to reliably detect gluten in foods at lower levels. In contrast, other comments said that more sensitive analytical methods should not be the determining factor in lowering the gluten threshold level unless there is scientific evidence (e.g., evidence-based, peer-reviewed published studies) demonstrating that 20 ppm gluten in foods labeled “gluten-free” is “toxic” to those with celiac disease.

(Response 6) We agree, in part, with the comments. If future data indicate that the gluten content of < 20 ppm is not sufficiently protective of the health of individuals with celiac disease and analytical methods become available that can reliably detect gluten in a range of food matrices at levels below 20 ppm, we will reevaluate the < 20 ppm gluten level that we have included as part of the criteria for the definition of “gluten-free.” We agree that any changes to this gluten level should be supported by all available data, including data on analytical methods as well as epidemiological and clinical data on the impact of any change on the health of individuals with celiac disease.

In sum, defining the term “gluten-free” for use in the voluntary labeling of food involves the consideration of multiple factors, including currently available analytical methods and the needs of individuals with celiac disease, as well as factors such as ease of compliance and enforcement, stakeholder concerns, economics, trade issues, and legal authorities. An important consideration is that, as the comments suggest, lowering the gluten level below 20 ppm will make it far more difficult for manufacturers to make food products that could be labeled as “gluten-free,” thereby reducing food choices for individuals with celiac disease. While the safety assessment results suggest that there may be some individuals with celiac disease who are highly sensitive to gluten exposure even at very low levels, the safety assessment, by its nature, may lead to a conservative, highly uncertain estimation of risk for these individuals. Given the various factors we have to consider and the data available to us, we decline to revise the rule to adopt a safety assessment-based approach at this time. However, if new data and information become available in the future that affect the factors we considered in defining “gluten-free,” we may consider whether further refinement of the “gluten-free” definition would be appropriate.

(Comment 7) A few comments asked how our proposed definition of “gluten-free” differed from those used in other countries. Many comments focused on the < 20 ppm gluten content as the only element of our proposed rule that would apply to international products. Other comments questioned how differences would affect the United States in international trade negotiations, considering the World Trade Organization Agreements on Technical Barriers to Trade (TBT Agreement) and Application of Sanitary and Phytosanitary Measures (SPS Agreement).

Several comments supported the proposed definition of “gluten-free” as an opportunity to harmonize international standards for this term. Some comments cautioned against using a lower gluten content value, stating that a lower level would not allow harmonization with international trading partners such as Canada and the European Union, which use a standard of no greater than 20 ppm gluten.

Many comments commented on a definition of “low gluten” as allowed in Australia and New Zealand. Most comments stated that “low-gluten” labeling is meaningless for individuals who wish to avoid gluten, but other comments supported “low-gluten” claims to allow for differences in individual gluten tolerance or personal preference.

(Response 7) The 2011 notice indicated that the < 20 ppm part of the criteria consistent with approaches taken by the Codex Alimentarius Commission's revised “Codex Standard for Foods for Special Dietary Use for Persons Intolerant to Gluten (Codex Standard 118-1979)” and also with the European Commission's Commission Regulation (EC) No 41/2009, concerning “the composition and labeling of foodstuffs suitable for people intolerant to gluten” (76 FR 46671 at 46674). The Codex Standard established a threshold of 20 mg gluten per kg of product (which is equivalent to 20 ppm gluten) for foods labeled “gluten-free,” and the European Commission regulation requires that foods labeled as “gluten free” not contain more than 20 ppm gluten (Refs. 25 and 26).

The final rule's definition of “gluten-free” is similar, but not identical, to requirements or positions by the Codex Alimentarius Commission, the European Commission, and Canada. For example, although our final rule, Codex Standard 118-1979, and European Commission Regulation No 41/2009 (Ref. 26) identify wheat, rye, and barley as gluten-containing grains, and allow foods containing ingredients made from wheat, rye, barley, or their crossbred varieties to be labeled “gluten-free” if the ingredients have been processed so that the gluten content in the food is reduced, the requirements differ in the amount of reduction required. Codex Standard 118-1979 and European Commission Regulation No 41/2009) require gluten in these ingredients not exceed 20 mg/kg, whereas our final rule requires the use of ingredients processed to remove gluten does not result in the presence of 20 ppm or more gluten in the finished food (§ 101.91(a)(3)(i)(A)( 3 )). In addition, our final rule also requires that any unavoidable presence of gluten in the food be below 20 ppm (see § 101.91(a)(3)(i)(A)( 3 ) and (a)(3)(ii)). Codex Standard 118-1979 and European Commission Regulation No 41/2009, in general, require that the gluten content “not exceed” 20 mg/kg in the food.”

We also note that, in June 2012, Health Canada described its position on gluten-free claims. Canadian regulations had previously defined “gluten,” in part, as any gluten protein from the grain of, or the grain of a hybridized strain created from, barley, oats, rye, triticale, or wheat, kamut, or spelt. In June 2012, however, Health Canada stated that: “Based on the available scientific evidence, Health Canada considers that gluten-free foods, prepared under good manufacturing practices, which contain levels of gluten not exceeding 20 ppm as a result of cross-contamination, meet the health and safety intent of [Health Canada regulation] B.24.018 when a gluten-free claim is made.” “Based on the enhanced labeling regulations for allergens and gluten sources, any intentionally added gluten sources, even at low levels (e.g. wheat flour as a component in a seasoning mixture which makes up a small proportion of the final food), must be declared either in the list of ingredients or in a ‘Contains' statement. In these cases, a gluten-free claim would be considered false and misleading. If, however, a manufacturer using a cereal-derived ingredient includes additional processing steps which are demonstrated to be effective in removing gluten, then the food may be represented as gluten-free” (Ref. 27). The Health Canada position that food labeled “gluten-free” not contain more than 20 ppm gluten is comparable to the final rule's criterion that foods labeled “gluten-free” cannot contain 20 ppm gluten or more gluten.

However, we recognize that our final rule differs in certain respects from requirements or positions taken by Health Canada and other countries or entities. For example, Codex Standard 118-1979, European Commission Regulation No 41/2009, Australia New Zealand Food Standards Code standard 1.2.8 (Ref. 28), and Health Canada include oats as gluten-containing grains, whereas our final rule does not. (We discuss oats in our response to comment 9.) Codex Standard 118-1979 and European Commission Regulation No 41/2009 also state that a gluten-free food is one whose “gluten level does not exceed” 20 mg/kg, and Health Canada's position is that a gluten-free food has a gluten content “not exceeding 20 ppm,” whereas our final rule defines “gluten-free” with respect to a gluten content of < 20 ppm. We do not consider the difference between “does not exceed 20 mg/kg or 20 ppm,” compared to our “< 20 ppm” gluten content criterion, to be significant because, as indicated in our discussion of comment 19, many foods labeled as “gluten-free” have a gluten content well below 20 ppm.

As another difference, we recognize that European Commission Regulation No 41/2009 requires foods for those intolerant to gluten to not contain gluten exceeding 100 mg/kg and to bear the term “very low gluten,” and Australia New Zealand Food Standards Code standard 1.2.8 requires that a food have “no detectable gluten” if it claims to be “gluten free.” The Australia New Zealand Food Standards Code also states that a food can be “low gluten” if the detectable gluten content is no more than 20 mg per 100 g of food, which is equivalent to no more than 200 ppm. Our final rule does not define the use of “low gluten” or “very low gluten” claims. If such claims were used in labeling, we would evaluate such claims on a case-by-case basis as to whether the claim was truthful and not misleading. We discourage the use of statements in labeling about the gluten content in foods other than “gluten-free.” (We discuss “low gluten” claims in our response to comment 25.)

Based on our review of products currently on the market, we do not believe that the differences between our final rule and standards, requirements, or positions taken by other countries or entities will adversely affect the ability of manufacturers to voluntarily use the “gluten-free” claim, as appropriate, on many foods.

a. Prohibited grains (§ 101.91(a)(1)). The proposed rule would define three terms. Proposed § 101.91(a)(1) would define “prohibited grain” as any one of three specific grains (wheat, rye, and barley) “or their crossbred hybrids (e.g., triticale, which is a cross between wheat and rye).”

(Comment 8) Several comments disagreed with or would revise the term “prohibited grain.” Some comments stated that the term is misleading because it implies that all consumers, rather than consumers with celiac disease or consumers who are allergic to those grains, should avoid the grains. Some comments suggested alternative terminology; for example, one comment suggested replacing the term “prohibited grain” with “specific grain.”

(Response 8) We agree in part and disagree in part with the comments. We agree that the word “prohibited” could create the misimpression that all consumers (rather than solely those individuals with celiac disease) should avoid these grains. We decline, however, to use the term “specific grains” because it does not provide any information as to what the term “specific” refers. Instead, we have revised § 101.91(a)(1) and corresponding language elsewhere in § 101.91(a) to refer to “gluten-containing grain” rather than “prohibited grain.” The term “gluten-containing grain” is simple, informative, and tied to the rule's definition of “gluten.” In addition, “gluten-containing grain” may avoid any misinterpretation of the rule's intent with respect to the consumption of gluten by individuals without celiac disease or other medical need to avoid gluten.

(Comment 9) Many comments addressed the use of oats as an ingredient that could be used in a food labeled “gluten-free.” Most comments supported the inclusion of oats as an ingredient in “gluten-free”-labeled foods. The comments stated that the scientific evidence indicates that the majority of individuals who have celiac disease can tolerate eating oats. The comments added that oats are a whole grain and contribute essential nutrients and fiber to a gluten-free diet and that oats add more dietary variety and appeal to following a gluten-free diet. Many comments favored the use of “gluten-free” labeling for food containing oats only if the food contains less than 20 ppm gluten. These comments stated that limiting the use of the “gluten-free” claim on these foods would make it easier for consumers to distinguish these oats from other commercially available oats that could contain higher levels of gluten due to cross-contact situations with gluten-containing grains. The comments stated that oats in food labeled “gluten-free” would provide individuals who have celiac disease and who are oat-tolerant more assurance that the product has been grown, processed, stored, and handled in a way to prevent incorporation of gluten.

Other comments opposed permitting oats in a food labeled “gluten-free.” These comments argued that not all individuals with celiac disease can tolerate oats and that FDA's definition of “gluten-free” should accommodate the needs of everyone who has celiac disease. Some comments stated that more research is needed to determine whether individuals with celiac disease should consume oats. Other comments stated that persons newly diagnosed with celiac disease and elderly persons with celiac disease are commonly advised not to introduce oats into their gluten-free diet until their small intestine has fully healed or that some individuals with celiac disease who are asymptomatic may be sensitive to oats and not know it. Finally, some comments said that if we do not prohibit oats in food labeled “gluten-free,” then the label should indicate if the food does or does not contain oats.

(Response 9) We agree with the comments that oats may be used as an ingredient in a food labeled as “gluten-free” provided that the food meets the definition of “gluten-free.” In other words, oats that contain 20 ppm or more gluten due to cross-contact may not bear a “gluten-free” claim. While oats are inherently gluten-free, we recognize that some oats may come in contact with gluten-containing grains during their production, processing, storage, or other handling practices. However, as we noted in the preamble to the proposed rule (72 FR 2795 at 2798), the commingling of oats with other grains appears to be preventable. At least two manufacturers who submitted written responses to our 2005 public meeting on gluten-free food labeling reported that the oats they market in the United States do not contain gluten from wheat, rye, and barley (Refs. 29 and 30). Other comments indicated that five brands of gluten-free oats are now commercially available in the United States.

We decline to prohibit the use of oats as an ingredient in foods labeled “gluten-free.” As we noted in the proposed rule, data suggest that the proportion of individuals with celiac disease who cannot tolerate oats in daily amounts of about 50 g or less dry weight is probably very low, possibly below 1 percent of the population of individuals with celiac disease, and there is no general agreement among experts about the extent to which oats present a hazard for individuals with celiac disease (72 FR 2795 at 2797 through 2798). Thus, for most individuals with celiac disease, oats can add whole grain options, nutrient enrichment, and dietary variety and appeal to a gluten-free diet. Individuals with celiac disease who cannot tolerate oats can use food label information to avoid eating foods labeled “gluten-free” that are made with oats or oat-derived ingredients. Examples of oat-derived ingredients include whole oats, rolled oats (also called oatmeal and oat flakes), steel-cut oats, oat flour, oat bran, and oat fiber. The term “oat” or “oats” is a part of the common or usual name for each of these ingredients and can be found in the food's ingredient list. For the reasons stated previously in this document, we also decline to revise the rule to require that foods labeled “gluten-free” bear additional language indicating that the food does or does not contain oats.

We recognize that there may be instances in which products could contain an oat-derived ingredient without “oats” in the name, but we did not receive any data or information on this possibility, and we are aware of only one such ingredient, a non-starch polysaccharide called “beta glucan,” which can be derived from multiple sources, including oats, and which is used in certain dietary supplements and to a much lesser extent in conventional foods (Ref. 31).

Because individuals with celiac disease who are sensitive to oats may wish to avoid all oat-derived ingredients, we encourage manufacturers of foods labeled “gluten-free” that use an oat-derived ingredient where the word “oat” does not appear in the ingredient list as part of any ingredient's name (e.g., beta glucans) to indicate in their labeling that an oat-derived ingredient is present.

(We understand that beta glucan may also be derived from barley, which, unlike oats, is a “gluten-containing grain” under § 101.91(a)(1). Similar to wheat starch, we consider beta glucan derived from barley to be an ingredient that has been processed to remove gluten because the process of deriving this ingredient is designed to selectively yield the desired polysaccharide and exclude other naturally occurring components, including protein.)

b. Gluten (§ 101.91(a)(2)). Proposed § 101.91(a)(2) would define “gluten” as “the proteins that naturally occur in a prohibited grain and that may cause adverse health effects in persons with celiac disease (e.g., prolamins and glutelins).”

(Comment 10) Several comments suggested that FDA revise the definition of “gluten” to mean “specific amino acid sequences” that naturally occur in a prohibited grain and that cause harmful effects by eliciting an immune response.

(Response 10) We decline to revise the definition as suggested by the comments. The comments did not explain how the definition would be improved by replacing “proteins” with “specific amino acid sequences” or by replacing “may cause adverse health effects” with “cause harmful effects by eliciting an immune response.” We also note that our definition of “gluten” is comparable to those used by Codex Standard 118-1979 and European Commission Regulation No 41/2009; both define “gluten” as “a protein fraction from wheat, rye, barley, oats, or their crossbred varieties and derivatives thereof, to which some [people] are intolerant and [that] is insoluble in water and 0.5M” sodium chloride solution. Consequently, except for replacing “prohibited grain” with “gluten-containing grain” (as we explained in our response to comment 8), we have finalized the definition of “gluten” without change.

c. “ Gluten-free” (§ 101.91(a)(3)). Proposed § 101.91(a)(3) would define the labeling claim “gluten-free” or similar claims as meaning that the food bearing the claim in its labeling does not contain any of the following: (1) An ingredient that is a prohibited grain; (2) an ingredient that is derived from a prohibited grain and has not been processed to remove gluten (e.g., wheat flour); (3) an ingredient that is derived from a prohibited grain and has been processed to remove gluten if use of that ingredient results in a presence of 20 parts per million (ppm) or more gluten in the food; and (4) 20 ppm or more gluten. The proposal also cited examples of similar claims, such as “free of gluten,” “without gluten,” and “no gluten” that would have to meet the same definition as the term “gluten-free.”

(Comment 11) Many comments asked us to develop a clear and consistent definition for the “gluten-free” labeling claim. However, one comment from a national organization committed to serving the celiac community noted that it had dietitians with expertise in the gluten-free diet develop a 15-question online consumer survey designed to obtain consumer input on the various questions posed by FDA as they related to consumers and their decisions and choices related to gluten-free products. The organization executed the online survey, open to consumers for 45 days, and collected over 5,000 responses. The comment indicated that 95 percent of the respondents preferred the term “gluten-free” to indicate that a product meets FDA's definition for “gluten-free,” as set forth in the proposed rule. The comment also noted that voluntary label statements, such as “may contain” or “processed in a plant with,” currently restrict consumer use of some foods. The comment said that these types of voluntary label statements would be unnecessary if consumers could rely on a “gluten-free” label that indicated a product had been tested to below 20 ppm. The comment suggested that we strive for “clarity” in all aspects of the regulation. Another comment suggested that any definition of “gluten-free” should facilitate a reasonable level of consistency among various products labeled as “gluten-free” and should ensure that individuals who are sensitive to or cannot tolerate gluten can rely on gluten-free products meeting the same minimum definition.

Several comments recommended a single labeling definition for “gluten-free” foods and believed multiple labels would be too confusing to the public. As one comment stated, “only one simple, clear standard claim like ‘gluten free' may simplify the identification of gluten-free products (with a gluten level below 20 ppm).”

One comment stated that we should expressly prohibit ambiguous statements, such as “No Gluten Added” or “Made from Gluten Free Ingredients.” Other comments expressed similar sentiments about variations of similarly worded claims. One comment said that manufacturers use such statements to suggest that the product is suitable for individuals with celiac disease, while simultaneously attempting to avoid liability for any gluten in the product that could result from cross-contact or cross-contamination during the manufacturing process. Similarly, other comments urged us to prohibit other claims about the presence or absence of gluten ingredients unless the food meets FDA requirements for a “gluten-free” claim.

(Response 11) We agree that the final rule should clearly define the term “gluten-free.” Section 206 of FALCPA directs the Secretary to define and permit use of the term “gluten-free” in the labeling of foods. Although proposed § 101.91(a)(3) would have defined “gluten-free” and include “or similar claim,” we have revised the final rule to define the term “gluten-free” without referring to “similar claims.” A single definition should help individuals with celiac disease identify foods that they can tolerate, without having to wonder whether foods bearing different label claims present different risks, and thus manage their diets more easily. Furthermore, as the comments suggest, it may be confusing to define “gluten-free” in a manner that also attempts to capture “similar claims.” For example, as the comments indicate, a claim such as “no gluten added” might not be similar to “gluten-free;” instead, a “no gluten added” claim could mean that the manufacturer did not increase the food's gluten content during the manufacturing process beyond whatever level of gluten the food contained before manufacturing. While another comment suggested that we prohibit other claims, our experience with lists of examples, such as listing the products subject to a rule, indicates that it may be impractical to list more examples of “similar” claims. (See, e.g., 66 FR 59138 at 59144 (November 27, 2001) (“FDA's experience demonstrates that, despite FDA's intentions to provide advice or clarity, whenever the agency attempts to provide complete descriptions of the products that are subject to a particular regulation or part, the descriptions are either misconstrued as being exhaustive or definitive (so that persons whose products are not identified or even slightly different from the products mentioned in the description claim that they are exempt from the rule) or must be constantly revised to add new products and to remove old products”).

Nevertheless, we recognize that some companies use claims that are similar to our definition of “gluten-free.” Our experience with other content claims on foods suggests that claims that a food contains “no gluten,” is “free of gluten,” or is “without gluten” (the examples of “similar claims” in proposed § 101.91(a)(3)) would be misleading if the food does not meet the definition for “gluten-free” specified in § 101.91(a)(3) (Ref. 32). Consequently, we have revised § 101.91(b)(2) to state that, “A food that bears the claim ‘no gluten,' ‘free of gluten,' or ‘without gluten,' in its labeling and fails to meet the requirements of paragraph (a)(3) of this section will be deemed misbranded.” In essence, we consider the statements “no gluten,” “free of gluten,” and “without gluten,” to be equivalent to a “gluten-free” claim. We use the term “requirements” to accurately describe the list of items in this paragraph. We discourage the use of statements in labeling about the gluten content of foods other than “gluten-free” and would evaluate any such statements under sections 403(a)(1) and 201(n) of the FD&C Act.

(Comment 12) Many comments requested that we establish a universal symbol/logo and/or a standardized print format for all manufacturers who wish to make a “gluten-free” claim on their food labels. The comments said that symbols, logos, or standardized print formats would make it easier for consumers to identify gluten-free foods, to reduce their time shopping, and to reduce possible confusion by having the same symbol appear in the same place using the same print format on foods bearing a “gluten-free” labeling claim. Comments from certification organizations suggested that consumers, particularly the most gluten-sensitive individuals, look for those symbols and understand what they mean.

Other comments opposed the use of a universal “gluten-free” symbol/logo. Some comments said that some manufacturers and grocery store chains have designed their own unique symbols/logos for identifying gluten-free foods and should be able to continue using these symbols/logos for labeling gluten-free foods or to use these symbols/logos on printed cards or other signs to call attention to gluten-free products sold in their stores. Still other comments noted several third party gluten-free certification programs that have developed their own specific “gluten-free” symbols/logos to identify foods that comply with particular criteria for a gluten-free food. One comment noted that some food companies seek independent, third-party certification for their gluten-free products. The comment urged us to not restrict the companies' use of certification programs or symbols. The comment said that inclusion of multiple “gluten-free” symbols on the same food or any restriction against continued use of third-party “gluten-free” certification program symbols/logos could make it more confusing or difficult for consumers to identify foods that met the criteria of those third-party “gluten-free” certification programs.

(Response 12) The proposed rule did not address the use of a universal symbol/logo, and we do not have any data indicating that mandating a universal symbol/logo is necessary to ensure that the claim is not false or misleading.

We are aware that some companies or organizations have developed specific phrases or symbols to indicate adherence to their own standards or to the standards of an independent gluten-free certification program for foods that meet specific criteria. We would review the use of any gluten-related claim not addressed in the final rule under sections 403(a)(1) and 201(n) of the FD&C Act.

(Comment 13) One comment noted that the proposed rule would allow a food to be labeled “gluten-free” if it uses an ingredient derived from a prohibited grain that has been processed to remove gluten, but would not allow a food to be labeled “gluten-free” if it used a prohibited grain or used an ingredient derived from a prohibited grain, if the processing of the food (instead of the ingredient) results in the removal of gluten to below 20 ppm in the final product. The comment said that processes exist that remove gluten from foods produced with gluten containing ingredients, and suggested that because the processes that remove gluten can occur at any stage in production, from the preparation of the ingredients to the finished product, the final rule should allow the use of the term “gluten-free” regardless of when the gluten removing process occurs.

(Response 13) Comments indicate that individuals with celiac disease search for “gluten-free” claims and also review the ingredient statement for specific ingredients. The final rule limits the use of gluten-containing ingredients to ensure the food, as consumed, contains as little gluten as possible. Allowing the “gluten-free” label claim on food whose ingredients have been processed to remove gluten, but not on food that has been processed to remove gluten helps ensure that the finished product has the lowest amount of gluten that is reasonably possible, and consistent with the use of specific manufacturing practices that can prevent gluten cross-contact situations. We plan to issue a proposed rule to address our compliance approach to foods that are, or contain ingredients that are, fermented or hydrolyzed, as discussed in response to comment 14. We anticipate that the proposed rule will include a discussion related to the whether it is feasible, and if so, under what circumstances, to process food to remove gluten.

(Comment 14) Several comments responded to analytical methods-related issues raised in our 2011 notice regarding a scientifically valid method that can be used to accurately determine if foods that are or contain ingredients that are fermented or hydrolyzed (i.e., in which chemical components are decomposed by reaction with water) contain < 20 ppm gluten to support “gluten-free” claims. Other comments discussed whether we also should require these manufacturers to maintain records on test methods, protocols, and results and to make these records available to FDA upon inspection.

Some comments, primarily from manufacturers of gluten detection test kits or the food industry, asserted that there are some competitive enzyme-linked immunosorbent assay (ELISA)-based methods that can accurately detect and measure gluten concentration levels in fermented and hydrolyzed foods as low as 0.24 mg/100 g or 2.4 ppm. These comments also maintained that these methods were validated to ensure that they perform reliably and can report test results in terms of intact gluten concentration or ppm gluten. Several other comments, particularly from those with celiac disease, celiac disease associations, or health professionals, wanted FDA to require records of test methods, protocols, and results to permit “gluten-free” claims on fermented or hydrolyzed foods. Some comments wanted the recordkeeping requirements to apply to all foods bearing a “gluten-free” claim.

(Response 14) We routinely rely upon scientifically valid methods  1 in our enforcement programs on food labeling. However, we are aware that currently available sandwich ELISA-based methods are not effective in detecting and quantifying intact gluten proteins in fermented and hydrolyzed foods. The sandwich ELISA-based methods designed to detect gluten require the presence of two antigenic epitopes and are not appropriate for fermented and hydrolyzed products.

In comparison to sandwich ELISA-based methods, competitive ELISA-based methods need the presence of a single antigenic epitope. However, without an appropriate reference standard to gauge the response, one cannot interpret the results on a quantitative basis that equates the response to intact gluten. Evidence in the scientific literature is currently lacking about a scientifically valid competitive ELISA method which confirms that any gluten peptides detected in a food sample can be accurately quantified in terms of ppm intact gluten protein. Therefore, we do not consider these methods scientifically valid for the purposes of analyzing fermented or hydrolyzed foods to determine compliance with this rule under § 101.91(c). We intend to issue a proposed rule to address how FDA will evaluate compliance with § 101.91(b) when an evaluation of compliance based on an analysis of the food using a scientifically valid method under § 101.91(c) is not available because the food is fermented or hydrolyzed or contains fermented or hydrolyzed ingredients. We intend to consider the need for issuing guidance for these foods to the extent the proposed rule does not issue before the compliance date for this final rule.

A “gluten-free” claim will be permitted on fermented and hydrolyzed foods or foods containing fermented or hydrolyzed ingredients that meet all of the requirements for bearing a “gluten-free” claim even though the gluten content of the food cannot be reliably measured pursuant to § 101.91(c). Until we establish provisions specifically for these foods, through further rulemaking, as is true for all food manufacturers who wish to use “gluten-free” labeling on their food, manufacturers of fermented or hydrolyzed foods or foods that use fermented or hydrolyzed ingredients are responsible for ensuring that the food bearing a “gluten-free” claim is not misbranded for failure to meet all of the requirements of the final rule. Manufacturers can implement measures that are necessary to prevent the introduction of gluten into the food during the manufacturing process to ensure that the finished product will comply with the provisions in § 101.91.

(Comment 15) Several comments concerned “gluten-free” labeling claims on beers. Some comments wanted FDA to allow beers to be labeled “gluten-free” if the beers contained less than 20 ppm gluten. One comment stated that, in some European countries, the traditional brewing processes for barley malt-based beers have been modified to ensure that beers labeled as “gluten-free” contain significantly less than 20 ppm of gluten.

In contrast, other comments favored prohibiting the use of a “gluten-free” claim on the label of beers made from gluten containing ingredients but were later “reduced” in gluten due to the processing methods.

(Response 15) The Alcohol and Tobacco Tax and Trade Bureau (TTB) is responsible for the issuance and enforcement of regulations with respect to the labeling of beers that are malt beverages under the Federal Alcohol Administration Act (FAA Act). Certain beers do not meet the definition of a malt beverage under the FAA Act (27 U.S.C. 211(a)(7)). These beers are not subject to the labeling requirements under the FAA Act and are subject to the labeling requirements administered by FDA (Ref. 33).

On May 24, 2012, TTB issued an interim policy on gluten content statements in the labeling and advertising of beverages or beers they regulate. The “Interim Policy on Gluten Content Statements in the Labeling and Advertising of Wines, Distilled Spirits, and Malt Beverages” allows the use of the following qualifying statement to inform consumers: “Product fermented from grains containing gluten and [processed or treated or crafted] to remove gluten. The gluten content of this product cannot be verified, and this product may contain gluten,” or “This product was distilled from grains containing gluten, which removed some or all of the gluten. The gluten content of this product cannot be verified, and this product may contain gluten.” (TTB Ruling No. 2012-2, May 24, 2012, available at http://www.ttb.gov/rulings/2012-2.pdf )

Beers subject to FDA's labeling requirements are those beers that are not made from both malted barley and hops but are instead made from either malted barley and no hops or with substitutes for malted barley (for example sorghum, millet, rice or buckwheat) with or without hops. Other beers subject to FDA's labeling requirements not brewed from gluten-containing grains may contain gluten through cross-contact with gluten-containing grains or ingredients during processing. (We also note that, for purposes of this discussion, we do not consider saké and similar products to be “beers.” Saké and similar products are treated as wine under the FAA Act and are subject to FDA's labeling requirements only if they contain less than 7 percent alcohol by volume.)

Beers are among the foods subject to fermentation during manufacturing. As discussed in our response to comment 14, we intend to issue a proposed rule to address how FDA will evaluate compliance with § 101.91(b) when an evaluation of compliance based on an analysis of the food using a scientifically valid method under § 101.91(c) is not available because the food is fermented or hydrolyzed or contains fermented or hydrolyzed ingredients.

We intend to address the “gluten-free” labeling of beers subject to FDA's labeling requirements in that proposed rule. However, the issues with respect to the labeling of FDA-regulated beers as gluten-free go beyond the question of how compliance can be verified. First, we note that consumers might not distinguish between those beers subject to FDA's labeling requirements and those beers subject to TTB's labeling requirements. Second, some comments have claimed that beers made from gluten-containing grains can be processed in a way that removes gluten. We are aware of a limited number of such products in the market. As with other fermented foods, we are not aware of any scientifically valid way to evaluate these claims, and there is inadequate evidence in the record concerning the effectiveness of the commenters' gluten removal process. We want to avoid any changes to labels that may cause further confusion with regard to “gluten-free” beer until we issue the separate rule on gluten-free labeling of hydrolyzed and fermented foods.

In light of these considerations, we intend to exercise enforcement discretion with respect to the requirements for “gluten-free” labeling for beers subject to FDA labeling requirements. Our consideration for enforcement discretion would extend to beers that currently make a “gluten-free” claim and that are: (1) Made from a non-gluten-containing grain or (2) made from a gluten-containing grain, where the beer has been subject to processing that the manufacturer has determined will remove gluten. This enforcement discretion pertains only to these beers subject to our labeling requirements that make a “gluten-free” claim as of August 5, 2013 pending completion of the rulemaking process with respect to fermented or hydrolyzed products. To the extent that a beer manufacturer wants to make a new gluten-free claim that is not present on a label as of August 5, 2013, they should contact FDA regarding the possible expansion of FDA's consideration for the exercise of enforcement discretion related to such labeling.

FDA expects beer manufacturers using a “gluten-free” claim to take appropriate measures to prevent cross-contact with gluten-containing grains during production, processing, storage, or other handling practices. We note that beer manufacturers, whose beers are subject to FDA's labeling requirements, that make beer from a gluten-containing grain or from non-gluten-containing grains are not precluded from using other statements on the label, such as a gluten statement consistent with the TTB guidance, about processing of beers to reduce gluten. However, such statements must be truthful and not misleading. Beers bearing a “gluten-free” claim, or other statements related to the gluten processing or content other than “gluten free,” are still subject to sections 403(a)(1) and 201(n) of the FD&C Act.

(Comment 16) Several comments claimed that individuals with celiac disease are concerned that gluten-containing ingredients used in food products may not be readily identifiable in the list of ingredients on food packages. The comments suggested that ingredients declared as “flavoring” or “modified food starch” could contain gluten or ingredients derived from gluten-containing grains. Some comments suggested that we require the source of these ingredients be declared on the label for foods bearing the “gluten-free” labeling claim.

(Response 16) We recognize that, in some situations, an ingredient that is a “flavoring” or “modified food starch” may be derived from a gluten-containing grain but nonetheless be present in a food bearing a “gluten-free” label. We note that the use of the “gluten-free” claim on a food label is voluntary and does not replace or eliminate any other labeling requirements. Wheat is a major food allergen under FALCPA and any food that is, or contains an ingredient that bears or contains, a major food allergen under section 201(qq) of the FD&C Act must declare either the word “Contains” followed by the name of the food source from which the major food allergen is derived, or the common or usual name of the major food allergen in the list of ingredients followed in parentheses by the name of the food source unless subject to an exception (section 403(w)(1) of the FD&C Act). A flavoring, coloring, or incidental additive that is, or that bears or contains, a major food allergen is subject to the labeling requirements of section 403(w)(4) of the FD&C Act. Section 101.91(b)(1) of the final rule states that we will consider a food bearing the claim “gluten-free” in its labeling to be misbranded if it fails to meet the requirements of paragraph (a)(3) of this section, which includes the requirement that any ingredient derived from a gluten-containing grain be processed to remove gluten such that its use in the finished product does not result in 20 ppm or more gluten in the food. Therefore, this final rule does not change the current labeling requirements for major food allergens, including wheat. To the extent the comment requests that we require that all ingredients in flavorings be listed in the ingredient statement, the request is outside the scope of this rulemaking.

(Comment 17) A few comments suggested that we establish a gluten limit for ingredients derived from gluten-containing grains that have been processed to remove gluten. One comment suggested 20 ppm as a reasonable limit to set for safety and ease of testing. Another comment suggested that if ingredients derived from gluten-containing grains must be used, and if the food complies with the maximum gluten content of 20 ppm, market practice will impose the same requirement at the ingredient level.

(Response 17) We decline to revise the rule to establish a specific gluten limit for ingredients derived from a gluten-containing grain that have been processed to remove gluten. As we discussed in the preamble to the proposed rule (72 FR 2795 at 2802), although ingredients such as wheat starch, are processed to remove gluten, there may be different methods of deriving these ingredients, and some methods may remove less gluten than others. The final rule provides that the use of such ingredients must not result in the presence of 20 ppm or more gluten in the finished food (i.e., 20 mg or more gluten per kg of food). To use additional adjectives to indicate that these ingredients have been “significantly” or “substantially” reduced in gluten would have little meaning given the variability in the gluten levels in the starting materials and the various processes used. Likewise, to establish gluten thresholds for these specific ingredients would add criteria to the definition of “gluten-free” that do not offer additional benefit to the protection of public health beyond those provided by the definition of “gluten-free.”

We agree that, as more manufacturers use ingredients derived from gluten-containing grains that have been processed to remove gluten, the market may respond by producing more ingredients that have been processed to reduce the gluten content even further and supporting the use of such ingredients in food products that meet the definition of “gluten-free.” Thus, we encourage suppliers of ingredients derived from a gluten-containing grain to process those ingredients using appropriate controls to achieve gluten content below 20 ppm. Manufacturers that are producing “gluten-free” foods may be more inclined to buy ingredients from suppliers that can produce ingredients with gluten content levels below 20 ppm. We would expect such manufacturers, as part of good manufacturing practice, to test the ingredient itself to ensure the gluten level in the ingredient is below 20 ppm. Alternatively, we would expect such manufacturers, as part of good manufacturing practice, to rely on a certificate of analysis for the ingredient, and to verify the accuracy and reliability of the certificate of analysis ensuring that the ingredient contains less than 20 ppm gluten. Such a certificate of analysis would be based on initial qualification and periodic re-qualification of the supplier through testing of the ingredient with sufficient frequency or at least once per year.

(Comment 18) One comment suggested that any commingling or cross-contact that may occur should not be evaluated under the < 20 ppm element of the definition, at least until such time as a safety-based threshold is established that would justify such inclusion. The comment asked that the final rule not condition voluntary use of the term “gluten-free” on whether a food contains 20 ppm or more gluten “for any reason” or on whether the product does not contain 20 ppm or more gluten if the product is made from oats.

(Response 18) The 20 ppm gluten threshold level is just part of the criteria used to define “gluten free.” The < 20 ppm part of the criteria for the definition of “gluten-free” is based on an analytical methods-based approach, not a safety-assessment-based approach. We recognize that gluten may be present in a food either because it is a component of an ingredient used to produce that food or through cross-contact during production, processing, storage, or other handling practices. Therefore, it is appropriate to use the same definition both for foods that have been formulated or processed not to contain 20 ppm or more gluten and for the presence of gluten in foods that do not inherently contain gluten, such as oats.

(Comment 19) Some comments expressed concern about some foods currently labeled as “gluten-free” having gluten content at or above 20 ppm or that many foods labeled “gluten-free” would contain the maximum permissible level of gluten near but still below 20 ppm.

(Response 19) Under the final rule, foods can no longer be labeled “gluten-free” if they contain 20 ppm or more gluten. The final rule uses an analytical methods-based approach to establish a gluten content of < 20 ppm as part of the criteria for defining the term “gluten-free.” Given the current unavailability of test methods that can reliably detect gluten at levels below 20 ppm, we conclude that “gluten-free” labeling on a food that contains less than 20 ppm gluten would be neither false nor misleading, so long as it conforms to all aspects of the final rule.

As for the comments expressing concern about some foods currently labeled as “gluten-free” having gluten content at or above 20 ppm, data submitted in comments to the proposed rule indicate that many products that are currently labeled as “gluten-free” have gluten content well below 20 ppm gluten. In addition we note that in surveys that have been conducted for foods labeled as gluten-free, available for sale in Canada, most samples contained less than 20 ppm of gluten (Ref. 27 at p. 4).

Proposed § 101.91(b) would establish three different requirements relating to the use of a “gluten-free” labeling claims.

a. Use of the “gluten-free” claim or similar claims. Proposed § 101.91(b)(1) would state that “A food that bears a “gluten-free” claim or similar claim in its labeling and fails to meet the conditions specified in paragraph (a)(3) of this section will be deemed misbranded.”

As we discussed earlier in our response to comment 11, the final rule now defines the term “gluten-free” without referring to “similar claims” or providing examples of similar claims. Section 101.91(b)(2) of the final rule states: “A food that bears the claim `no gluten,' `free of gluten,' or `without gluten' in its labeling and fails to meet the requirements of paragraph (a)(3) of this section will be deemed misbranded.” In essence, we consider the statements “no gluten,” “free of gluten,” and “without gluten” to be equivalent to a gluten-free claim. We are planning educational efforts to help consumers learn that when they see foods labeled as being “gluten-free,” the term will have a consistent meaning and, therefore, be a reliable tool when planning a gluten-free diet.

On our own initiative, we also have revised § 101.9(b)(1) to refer to “the requirements of paragraph (a)(3) of this section” instead of “the conditions specified in paragraph (a)(3) of this section.” This change corresponds to the language used in § 101.91(b)(2) of the final rule.

b. Foods that do not inherently contain any gluten. Proposed § 101.91(b)(2) would apply to foods that do not inherently contain any gluten from a prohibited grain (now referred to as a gluten-containing grain in the final rule), but would exclude foods made from oats. In brief, proposed § 101.91(b)(2) would consider such foods that bear a “gluten-free” claim to be misbranded unless the claim “refers to all foods of that same type (e.g., `milk, a gluten-free food,' `all milk is gluten- free')” and the food does not contain 20 ppm or more gluten.

We invited comments and scientific information on whether a “gluten-free” claim on an inherently gluten-free food would be misleading in the absence of additional qualifying language.

(Comment 20) While a few comments supported proposed § 101.91(b)(2) as written, most comments expressed significant confusion as to the requirements for labeling foods inherently free of gluten. Numerous comments expressed concern that the rule would result in foods inherently free of gluten being deemed misbranded or “illegal” if they claimed to be “gluten-free.” The comments did not appear to understand that the proposed rule would find these foods misbranded only if they omitted the qualifying language when they claimed to be “gluten-free” (assuming they met the other criteria for a “gluten-free” labeling claim).

Other comments discussed the proposed qualifying language. The comments expressed concern that, in many instances, it would be misleading to suggest that a particular food or food category is always gluten-free. Some comments referred to the issues discussed in our analysis of oats in the proposed rule (72 FR 2795 at 2801), noting that cross-contact with gluten-containing ingredients can and does occur in virtually any facility where gluten-containing ingredients are present. One comment stated that “requiring that inherently gluten-free foods electively labeled `gluten-free,' declare that all such foods are gluten-free, is to deny the cross-contact risks to which many inherently gluten-free foods are regularly exposed. Furthermore, requiring such a statement devalues the efforts of manufacturers who employ exhaustive measures to remedy those risks of cross-contact. That type of reference, in effect, tells the consumer that foods labeled `gluten-free'—and subject to federal regulations—are no more safe than those bearing no claim at all. Enforcing a requirement of such an advisory will perpetuate the confusion and risks to individuals with celiac disease that FALCPA is expected to undo.”

Other comments noted that certain foods of the same type may be available in flavored and unflavored forms or with additional ingredients that may contain traces of gluten. Many comments cautioned that, if one product used a “gluten-free” claim with the qualifying language (i.e., a statement that all foods of that type are gluten-free), some consumers may pick a flavored or formulated, gluten-containing version of the product and mistakenly believe that it also is inherently free of gluten. A few comments suggested that the proposed qualifying language for foods that inherently do not contain gluten would only be appropriate for single ingredient foods which are not flavored nor have added ingredients. Several comments urged us to allow an unqualified “gluten-free” claim if the food meets the definition of “gluten-free.” They emphasized that this unqualified labeling would be useful to consumers who are seeking gluten-free products.

Other comments explained that the proposed additional clarifying wording indicating that all foods of the same type, not just the brand bearing “gluten-free” labeling claim, also are free of gluten could compel manufacturers to make representations about all products in a given category, including products that the manufacturer does not make or cannot control. Some comments explained that companies are willing to support that their own products may bear a “gluten-free” claim (< 20 ppm gluten), but do not wish to make a statement suggesting that other companies have made the same determination or have the same controls or manufacturing practices to minimize or prevent contact with gluten.

Many comments suggested that we establish a simple “gluten-free” claim, regardless of whether the product is inherently gluten-free or formulated to be gluten-free. To minimize consumer confusion, many comments suggested that the final rule allow a “gluten-free” claim on products that have been processed in a manner that ensures the products meet the definition of “gluten-free” and contain less than 20 ppm gluten. The comments also suggested that consumers seeking to avoid gluten do not care if the food is inherently (or “naturally”) gluten-free or processed to remove gluten by formulation or ingredient substitution.

Other comments explained that the proposed requirements for qualifying language could have an unintended consequence as it could cause companies to stop labeling their products as “gluten-free,” rather than deal with misbranding issues. The comments indicated that such a result would frustrate consumers because there would be fewer foods labeled as “gluten-free.”

(Response 20) We understand how the proposal's additional clarifying language for foods inherently free of gluten could cause confusion and concern for the consumers seeking foods with a “gluten-free” labeling claim. We agree with the comments stating the requirement for qualifying language on foods that inherently do not contain gluten could be interpreted as saying that it is the nature of the food, rather than the care provided by the company making the “gluten-free” claim, that ensures the product meets the definition of “gluten-free.” Likewise, we agree with the comments suggesting that, in this situation, requiring companies using the “gluten-free” claim to add the qualifying language that all foods of the same type are also gluten-free would, in effect, require the companies to make representations as to the gluten-free status of products outside of their control. We agree that such qualified labeling on one brand of food that inherently does not contain gluten could mislead consumers into assuming that a flavored or formulated gluten-containing version of that product is also gluten-free, and could result in an individual with celiac disease consuming gluten and possibly suffering negative health consequences as a result.

Consequently, we conclude that a “gluten-free” claim, without qualifying language, on a food that is inherently free of gluten is not misleading. We have revised the final rule so that a food labeled as “gluten-free” must meet the definition of “gluten-free” in § 101.91(a)(3), but will not require additional qualifying language. This final rule will allow us to determine whether specific “gluten-free” labeling claims are misleading on a case-by-case basis. A food bearing a “gluten-free” label must meet each of the relevant criteria in the “gluten-free” definition, and qualifying language would not be necessary for consumers to understand the meaning of the term “gluten-free” with respect to other foods, including those that may also be inherently free of gluten. There may be inherently gluten-free foods that still may not meet the definition of “gluten-free” due to cross-contact with gluten that leads to gluten content in the food that are at or above 20 ppm. There also may be inherently gluten-free foods that have some cross-contact with gluten-containing products, but are still able to bear the “gluten-free” claim because the presence of gluten in the food due to cross-contact is less than 20 ppm. Thus, the approach we have taken in the final rule should result in labeling that is easier for consumers to understand. We note that, in changing our approach to “gluten-free” claims on inherently gluten free foods we are making a determination that, in many situations “gluten-free” labeling is unlike the “free” labeling claims (nutrient content claims) made for foods inherently free of calories, nutrients such as sodium or fat, and other food substances such as cholesterol (see 21 CFR 101.13(e)(2) and 72 FR 2795 at 2802). The general rationale behind the labeling of “free” claims is that, as we explained in the preamble to the proposed rule, “[i]f a single brand of food inherently free of the substance that is the subject of its ‘free' labeling claim does not also include additional qualifying language, consumers may mistakenly assume that only the particular brand of the food is free of the substance and may not understand that other brands of the same type of food that do not make the `free' labeling claim are also free of the substance” (See id.). As noted previously, some comments challenged the logic of that rationale in the context of gluten-free labeling and indicated that firms did not want to make representations as to the gluten-free status of products outside of their control, because it could result in adverse health consequences to consumers. We concur with these comments.

We have removed proposed § 101.91(b)(2) and its subparagraphs (i) and (ii), and we reorganized the final rule to include § 101.91(a)(3)(i)(B) stating that the definition applies if the food inherently does not contain gluten and, as stated in § 101.91(a)(3)(ii), any unavoidable presence of gluten in the food is below 20 ppm gluten.

Proposed § 101.91(c) would indicate that, when compliance is based on an analysis of a food, we would “use a method that can reliably detect the presence of 20 ppm gluten in a variety of food matrices, including both raw and cooked or baked products.” In the 2011 notice, we stated our tentative conclusion that the analytical methods we would use to assess compliance with the < 20 ppm gluten content “should be specified in codified language” (76 FR 46671 at 46673). However, the 2011 notice also stated that we recognized that some food matrices, such as fermented or hydrolyzed foods, may lack currently available scientifically valid methods that can be used to accurately determine if these foods contain < 20 ppm gluten (id.). In such cases, we indicated that we were considering whether to require manufacturers of such foods to have a scientifically valid method that will reliably detect gluten at 20 ppm or less before including a “gluten-free” claim in the labeling of their foods.

(Comment 21) Several comments addressed whether the final rule should specify the analytical methods we would use to assess compliance. In general, the comments advised against specifying analytical methods in the rule. One comment, for example, said that a number of adverse effects could result, including:

• The possibility that the analytical methods we chose would become outdated quickly. The comment indicated that there are two or more additional commercially available test kits that offer peer reviewed performance that is at least equivalent to the analytical methods (the ELISA R5- Mendez Method and the Morinaga method) we had identified in the 2011 notice (76 FR 46671 at 46672).

• Limiting the testing options for food manufacturers and regulatory and commercial laboratories. The comment expressed concern that identifying specific analytical methods in the final rule could result in problems when a specific kit becomes unavailable on a temporary basis or if the kit was changed or removed from market for any reason.

• Limiting our flexibility to use improved technology as it becomes available and dissuading test kit manufacturers from developing improved methods.

(Response 21) Upon further consideration, we agree that specifying the analytical methods in the final rule could limit our flexibility and possibly deter the development of new and better analytical methods. We also note that specifying the analytical methods we would use for compliance purposes, as part of the final rule, would not be binding on food manufacturers because neither the proposed rule nor this final rule requires them to use the same analytical methods to determine the gluten content. To the extent that food manufacturers or other interested parties want to know the specific scientifically valid method we intend to consider using when determining compliance, we can identify this method through other means (such as through a guidance document).

If we were to specify analytical methods in the final rule that FDA is to use to determine compliance with the final rule, and the methods are revised, we would have to, by regulation, change the methods specified in the rule. The revisions to the methods may be more than a technical change and require notice and comment rulemaking. As one comment recognized, if we had to engage in rulemaking to revise or update analytical methods, we would run the risk that the analytical methods specified by regulation would become outdated or obsolete quickly (especially if the methods were revised or updated frequently) and that we would deter the development of better test methods. We have, however, revised § 101.91(c) by inserting “scientifically valid” before “method” to make clear that we will use a scientifically valid method for purposes of compliance testing.

As for the comments regarding the use of performance criteria, the comments did not provide any data and information on which the Agency could rely to support such an approach. Therefore, we are not making changes in response to this comment.

(Comment 22) Many comments discussed how manufacturers might comply with the rule. The comments asked that we require foods (including oats) to be “certified” or verified that they do not contain 20 ppm or more gluten and to meet all other FDA requirements for a gluten-free food before being labeled “gluten-free.” The comments argued that certification would provide assurance that foods bearing this claim do not contain levels of gluten at or above 20 ppm. Many comments expressed the concern that cross-contact with gluten-containing ingredients could result in the inadvertent presence of gluten in a food labeled “gluten-free.”

(Response 22) We decline to revise the rule to require certification that foods comply with the definition and requirements regarding a “gluten-free” claim. Under sections 403(a)(1) and 201(n) of the FD&C Act, manufacturers must ensure that all statements they include on their food labels are truthful and not misleading. The final rule defines the term “gluten-free,” but does not require manufacturers to use a particular test methodology or to certify their products.

Additionally, given the range of food products and methods of manufacturing, it would be impractical and an inefficient use of our resources for us to require, through regulation, a precise manner in which manufacturers must or should certify or verify the gluten content of their products. Manufacturers are free to develop their own methods that best suits their particular needs to determine the gluten content of their products. In addition, other methods may be used for quality control, specifications, contracts, surveys, and similar non-regulatory functions. Some companies may choose, but are not required, to have third parties certify or verify the gluten content of their product to ensure their products labeled as “gluten-free” are within the definition of “gluten-free.”

Several comments addressed matters that were not specific to a particular provision in the proposed rule or issues not covered by the rule. We address those comments here.

(Comment 23) In the preamble to the proposed rule, we recognized that even those foods that comply with the proposed definition of “gluten-free” nonetheless could contain some amount of gluten up to 20 ppm (72 FR 2795 at 2803). We questioned whether the potential presence of some gluten below 20 ppm would be a material fact that would make a “gluten-free” claim potentially misleading. We invited comments on whether the use of additional qualifying language (e.g., “does not contain 20 ppm or more gluten per gram of food”) would be necessary to inform individuals with celiac disease that a food labeled as “gluten-free” nonetheless may contain the amount of gluten permitted under whatever threshold level is established in the final rule. The 2011 notice repeated the invitation for comments and provided an example of such qualifying language in the form of “a possible asterisk after the term ‘gluten-free' and an associated statement that says, e.g., ‘does not contain 20 ppm or more gluten’ ” (76 FR 46671 at 46675).

We received comments both supporting and opposing the addition of language to indicate that foods labeled “gluten-free” could have the potential presence of less than 20 ppm gluten in the product. Comments supporting the inclusion of this language on the label explained that this would inform consumers about the meaning of the “gluten-free” claim. Many comments indicated that the public should receive truth in labeling and therefore the label should indicate the presence of even trace amounts of gluten.

In contrast, comments opposing the additional qualifying language stated that it would likely confuse consumers without providing any additional benefits. One comment noted that there appears to be no other health-related claims (e.g., fat-free, sugar-free, low-sodium) that define or further qualify the regulatory definition via additional labeling statements and that “a good labeling regulation does not distort a valid, established public health standard.” In addition, some comments suggested the additional language could discourage manufacturers from making a “gluten-free” claim on products that are inherently gluten-free and produced under cGMPs. The comments said that manufacturers whose foods had gluten content well below 20 ppm could refrain from labeling their food as “gluten-free” because the qualifying language could mislead consumers into assuming most products contain the maximum levels of gluten.

(Response 23) We agree with the comments opposing the use of qualifying language to inform individuals with celiac disease that a food labeled as “gluten-free” nonetheless may contain less than 20 ppm of gluten because the final rule defines the criteria and requirements for the “gluten-free” labeling claim. The lawful use of the federally defined term “gluten-free” on a food label will inform both consumers and industry of the fact that the food bearing the “gluten-free” claim may not contain 20 ppm or more gluten. Education and outreach programs will be important to ensure that individuals with celiac disease and other consumers understand the definition and the changes set forth by these regulations.

We also agree with the comment that additional qualifying language that would, in effect, restate § 101.91(a)(3) would be inconsistent with other FDA regulated labeling claims (e.g., fat-free, sugar-free) that define the term without the need to further qualify that regulatory definition elsewhere on the label.

We also agree with the comments suggesting that additional qualifying language could create a disincentive for manufacturers to make a “gluten-free” claim. For example, if a manufacturer's food had less than 5 ppm gluten, but the final rule would require the manufacturer to state “does not contain 20 ppm or more gluten” in addition to the “gluten-free” claim, the manufacturer might decide to remove the “gluten-free” claim rather than risk creating the misimpression that its food contained up to 20 ppm gluten. Additionally, if a manufacturer could improve its manufacturing or processing operations to create a food with less than 5 ppm gluten, but the final rule would require the statement of “does not contain 20 ppm or more gluten,” the manufacturer might decide to forego those improvements because the statement would only refer to “20 ppm or more gluten.” Requiring the additional qualifying language, therefore, could result in fewer “gluten-free”-labeled foods being available and limit the ability of individuals with celiac disease to follow a gluten-free diet.

We do not agree with the comments supporting the additional qualifying language. While we acknowledge the desire of some consumers to know the exact gluten content of foods, we adopted an analytical methods-based approach, with a threshold level of 20 ppm gluten, because we determined that this level is appropriate, enforceable, and practical after considering multiple types of information, including the scientific literature on the sensitivity of consumers with celiac disease and information on the methods available to reliably detect and quantify gluten in a wide variety of foods.

Therefore, the final rule does not require the use of additional qualifying language (e.g., “does not contain 20 ppm or more gluten”) to inform individuals with celiac disease that a food labeled as “gluten-free” nonetheless may contain less than 20 ppm gluten.

(Comment 24) A few comments asked about the inclusion of wheat starch in foods labeled “gluten-free.” Proposed § 101.91(a)(3)(iii) would allow a food to bear a “gluten-free” claim provided that any ingredient that is derived from a prohibited grain has been processed to remove gluten (e.g., wheat starch), if the use of the ingredient does not result in the presence of 20 ppm or more gluten in the finished food. Wheat starch is an ingredient derived from wheat (a gluten containing grain) that has been processed to remove gluten. As discussed in our response to comment 17 (regarding a < 20 ppm gluten content level applied to individual ingredients), a comment suggested that if ingredients derived from gluten-containing grains must be used, and if the food complies with the maximum gluten content of < 20 ppm, market practice will impose the same requirement at the ingredient level (in other words, ingredient purchasers will require that the ingredients contain less than 20 ppm gluten). Several comments submitted by individuals with celiac disease indicated that they would not purchase a product that included the term “wheat” within the ingredient list. The comments noted that because wheat is considered a “major food allergen” under FALCPA the term wheat could appear either in the list of ingredients or in a separate “Contains wheat” statement near the list of ingredients. One comment said that if wheat must be identified on the label of a food that also bears a “gluten-free” claim, consumers will not be able to determine whether the food is appropriate for them to consume and will have to avoid the food. The comment suggested that the result would be an unnecessary restriction in an already restrictive diet and also suggested that individuals with celiac disease will receive a confusing message that wheat starch in food labeled “gluten-free” is acceptable, but wheat starch in other foods must be avoided.

(Response 24) We agree that individuals with celiac disease would receive a confusing message if foods bearing a “gluten-free” claim also include the term “wheat” in the ingredient list or in a “Contains” statement, as required by FALCPA (Ref. 34). Although we were unable to identify many products bearing a “gluten-free” claim that also have the term “wheat” appearing in the ingredient list, a food may bear both a “Contains wheat” statement under § 101.91(b)(3) of the final rule and a “gluten-free” claim or a claim identified in § 101.91(b)(2) of the final rule and be in compliance with both section 203 of FALCPA (regarding food labeling for allergenic substances) and the “gluten-free” label regulation arising from section 206 of FALCPA. In such situations, § 101.91(b)(3) requires that the labeling also bear the statement that “The wheat has been processed to allow this food to meet FDA requirements for gluten-free foods,” preceded by an asterisk (*) or other symbol that links this statement to the word “wheat,” either in the ingredient list or the “Contains wheat” statement, depending on how the allergen declaration is made. Without this statement, a food that identifies the presence of wheat either in the ingredient statement or in a “Contains wheat” statement under § 101.91(b)(3) and bears a “gluten-free” claim under § 101.91(a)(3)(i)(A)( 3 ) will be deemed misbranded.

We also included “or a claim identified in paragraph (b)(2) of this section” in § 101.91(b)(3) to clarify that this disclaimer is also needed when a food bears the term “wheat” in the ingredient list or a separate “Contains wheat” statement and also contains a “no gluten,” “free of gluten,” or “without gluten” claim.

(Comment 25) The preamble to the proposed rule acknowledged that at least one other regulatory body outside the United States has developed a two-tiered approach to gluten-related food labeling (72 FR 2795 at 2804). Australia and New Zealand have established standards for “gluten-free” (meaning no detectable gluten) and a less restrictive standard for “low-gluten” (meaning no more than 20 mg gluten per 100 g of the food, which is equivalent to no more than 200 ppm gluten in the food) (Ref. 28). The preamble to the proposed rule also discussed the possible development of a similar 2-tiered approach to gluten-related food labeling in the United States (72 FR 2795 at 2811 through 2812). At the time we issued the proposed rule, we tentatively had concluded that a two-tiered approach was not feasible because we do not have sufficient scientific data to recommend a specified level of gluten to define the term “low gluten.” We invited comments on this tentative conclusion, including comments on a possible scientific basis for setting a level of gluten to be defined as “low gluten.”

Several comments addressed the issue of “low-gluten,” “very low-gluten” or other tiered gluten labeling claims. Most comments opposed tiered gluten labeling claims. The comments agreed with us that there is no scientific basis for these claims and such claims would not benefit individuals with celiac disease. For example, many comments noted a preference for a single definition of “gluten-free,” stating that a dual definition of “gluten-free” and “low-gluten” would be confusing. The comments suggested that terms implying various gluten content levels may confuse individuals with celiac disease who are advised to follow a gluten-free diet rather than one that is low in gluten or gluten-reduced. Comments opposed to the use of “low-gluten” claims or tiered gluten labeling also expressed concerns that these other claims may influence individuals with celiac disease to substitute such foods for foods labeled “gluten-free” and thereby jeopardize their health.

Other comments said we should establish a tiered gluten labeling system allowing individuals with celiac disease, especially those very sensitive to gluten, to distinguish between foods that do not have any gluten and those that contain a trace amount of gluten. Most comments expressing this opinion favored defining “gluten-free” to mean either zero, no detectible, or < 5 ppm gluten and defining the term “low-gluten” to mean a greater amount of gluten than allowed for a “gluten-free” food, but no more than 20 ppm (e.g., < 5 ppm or < 10 ppm for a “low-gluten” claim). Some comments said we should consider allowing “low-gluten” claims consistent with those used in other countries. Several comments expressed support for the two-tiered gluten labeling system in effect in Australia and New Zealand. One comment suggested the term “celiac safe” to mean < 20 ppm and another comment suggested the terms “Gluten-0” for no gluten, “Gluten-5” or “Lo Gluten 5” for no more than 5 ppm gluten, and “Gluten-20” or “Lo Gluten 20” for no more than 20 ppm gluten).

(Response 25) We decline to define the terms “low-gluten,” “very-low gluten,” or other terms mentioned by the comments or to adopt a tiered gluten labeling system. We agree with comments that stated that tiered labeling claims would likely be confusing to those with celiac disease if there was a proliferation of “low-gluten” or “very-low-gluten” claims on food labels. With respect to the other terms suggested by the comments, we continue to lack a scientific foundation for developing definitions for these terms. We also decline to define terms for gluten content below 20 ppm because, as of the date of this final rule, given the current unavailability of appropriate test methods that can reliably and consistently detect gluten at levels below 20 ppm.

Because it is currently not known what amount of gluten would be appropriate for foods bearing a “low-gluten” or a “very-low-gluten” claim, we have decided only to define “gluten-free” as described in § 101.91(a)(3).

(Comment 26) Many comments asked that we require the labels of food bearing a “gluten-free” claim to state on the label the total amount of gluten contained in the food (e.g., based upon a gluten analysis of the food). Some comments suggested that we require food labels to declare the amount of gluten present per serving of food in the Nutrition Facts label. Some comments asserted that consumers want to be able to compare “gluten-free”-labeled foods and choose those with the lowest gluten content to reduce their potential health risks or to estimate their total daily cumulative gluten intake as a way to manage their gluten-free diet. Some comments stated that many consumers do not understand the meaning of a < 20 ppm gluten criterion for a “gluten-free” food. Other comments argued that this information is necessary for the label to be truthful and not misleading, or that consumers view the declaration of gluten within the Nutrition Facts label to be consistent with the manner in which we require nutrients to be declared on food labels.

(Response 26) We decline to require an analysis of the food and resulting declaration on the label of the total amount of gluten contained in a food bearing a “gluten-free” claim as discussed in our response to comment 4. Declaring the results of such testing would not be consistent with the purpose of developing a consistent definition of the term “gluten-free” to mean that the food contains < 20 ppm gluten and conforms to the final rule's other elements.

To the extent comments seek to add a gluten declaration as part of the Nutrition Facts label, such a request is outside the scope of this rule. However, whether or not a “gluten-free” labeling claim is made, we will not object if manufacturers voluntarily provide the amount of gluten present in their food elsewhere on the food label, as long as such a statement is truthful and not misleading. Such voluntary information must comply with all other rules regarding labeling.

(Comment 27) Several comments requested that we permit “gluten-free” claims on foods in the form in which they are consumed rather than foods as packaged. The comments noted that certain foods (e.g., dried soup mixes), when prepared according to package directions (e.g., prepared with water), would meet the definition of a “gluten-free” food.

In contrast, other comments stated that a “gluten-free” claim should apply to the food “as packaged” instead of the food “as prepared.” The comments said that individuals with celiac disease might consume a food bearing a “gluten-free” claim in ways other than those specified in the preparation directions. The comments wanted the assurance that foods, “as packaged” and bearing a “gluten-free” claim, meet all FDA requirements for a “gluten-free” food.

(Response 27) The “gluten-free” claim applies to foods “as packaged” and not “as prepared” according to package directions. This requirement is consistent with our other statutory labeling requirements and implementing regulations. While we understand that setting the criteria for “gluten free” claims based on a food “as packaged” may not allow certain foods to bear a “gluten-free” claim, we agree that some individuals with celiac disease who purchase “gluten-free” labeled foods may wish to consume those foods in ways other than those stated in the package directions. For example, instead of reconstituting a dried soup mix according to instructions, a consumer may wish to use that mix in a concentrated form to flavor other foods or to prepare a vegetable dip. If a food sold in a concentrated form were dependent upon food preparation using package directions to ensure the prepared food conforms to this final rule and contains less than 20 ppm gluten, errors in preparation or alternative use of the packaged food product could result in persons with celiac disease consuming foods with gluten content higher than that permitted by our definition of “gluten-free.”

(Comment 28) Some comments expressed concern that individuals with celiac disease also are exposed to gluten in drugs, dietary supplements, or cosmetics. A few comments wanted us to develop a rule that would be applicable to the labeling of drugs, dietary supplements, and cosmetics in addition to foods.

(Response 28) The final rule does apply to dietary supplements. We are issuing the final rule under FALCPA. FALCPA's requirements apply to all packaged foods sold in the United States that are regulated under the FD&C Act, including both domestically manufactured and imported foods. Section 201(ff) of the FD&C Act states that “Except for purposes of section 201(g) [definition of drug], a dietary supplement shall be deemed to be a food within the meaning of this Act.” Accordingly, the final rule applies to dietary supplements. The use of a “gluten-free” claim in food labeling including the labeling of dietary supplements is voluntary and does not replace or eliminate any other labeling requirements.

Requirements related to “gluten-free” labeling on drugs and cosmetics are outside the scope of this rule. We note that, in the Federal Register of December 21, 2011, we published a notice inviting information and comments about ways to help individuals with celiac disease avoid the presence of gluten in drug products (76 FR 79196). The notice also invited information on ingredients in human drug products that are currently derived from wheat, barley, or rye. The comment period closed on March 20, 2012, and FDA's Center for Drug Evaluation and Research is reviewing those comments. As for cosmetics, should we receive data or information indicating that cosmetics present a concern for individuals with celiac disease, we may consider whether further action is warranted.

Additionally, we wish to clarify that this rule pertains to food intended for human use. Although we are aware of gluten claims with respect to food intended for animals, our rulemaking activities have focused on defining the term “gluten-free” in a manner that would help humans concerned about managing the gluten in their diet.

(Comment 29) A few comments asked how our definition of “gluten-free” would apply to individuals who have an immunoglobulin E-mediated (IgE-mediated) food allergy to wheat, or other non-celiac disease conditions related to consumption of gluten. The comments asked us to consider their needs in defining “gluten-free.”

(Response 29) We considered a number of factors, including the needs of individuals who have a food allergy to wheat or are sensitive to gluten, in developing this final rule. We are issuing the final rule under, in part, section 206 of FALCPA. In general, FALCPA's requirements apply to all packaged foods sold in the United States that are regulated under the FD&C Act, including both domestically manufactured and imported foods. Additionally, section 203 of FALCPA requires food manufacturers to declare, on the label, if a product contains an ingredient that is one of the eight major food allergens or that contains protein from a major food allergen.

The use of “gluten-free” on a food label is voluntary and does not replace or eliminate any other labeling requirements. Therefore, any food containing an ingredient that is a major food allergen under section 201(qq) of the FD&C Act must declare the presence of that ingredient as described in section 403(w)(1) of the FD&C Act.

As we discussed in our response to comment 24, the labeling of wheat as a major food allergen would present the potential for confusion with the “gluten-free” claim. Rather than prohibit the use of the “gluten-free” claim on products that have used ingredients derived from wheat that have been processed to remove gluten and comply with the definition of “gluten-free,” and considering the potential for individuals with an IgE-mediated wheat food allergy to experience adverse health effects in response to servings of food containing residual wheat protein levels below 20 ppm, we have added another requirement for additional qualifying language in § 101.91(b)(3) of the final rule. Section 101.91(b)(3) provides that a food that bears the term “wheat” in the ingredient list or in a separate “Contains wheat” statement in its labeling as required by section 403(w)(1)(A) of the FD&C Act and also bears the claim “gluten-free” will be deemed misbranded unless its labeling also bears additional language (set forth in the rule) clarifying that the food complies with FDA requirements for a “gluten-free” claim.

(Comment 30) A few comments addressed farmers, food companies, and restaurants making “gluten-free” claims about their grains/crops, food products, or menu items, respectively. The comments were concerned that these foods could contain gluten due to common cross-contact situations. Other comments expressed the concern that food service personnel may not be thoroughly trained and knowledgeable about the need to segregate gluten-free and non- gluten-free products, and the dietary needs of the celiac population.

(Response 30) Under the final rule, manufacturers making a “gluten-free” claim on their labeling must ensure that such foods, in addition to meeting the other criteria, do not contain 20 ppm or more gluten, including the unavoidable presence of gluten due to gluten cross-contact situations or migration from packaging materials.

With respect to restaurants, FDA guidance suggests that any use of an FDA-defined food labeling claim (e.g., “fat free” or “low cholesterol”) on restaurant menus should be consistent with the respective regulatory definitions (Ref. 35).

As for food service personnel, issues regarding the training of food service personnel are beyond the scope of this rulemaking.

(Comment 31) A few comments asked if we intend to issue guidance to industry regarding “gluten-free” labeling.

(Response 31) Section 206 of FALCPA directs us to engage in rulemaking to define and permit the use of the term “gluten-free” on the labeling of foods. We anticipate that manufacturers wishing to label their products as “gluten-free” will be able to understand and comply with the final rule without difficulty. We intend to issue guidance about the ELISA-based methods (Refs. 36 and 37) FDA will use when analysis of a food would be necessary in order to determine regulatory compliance with FDA's definition of “gluten-free” for a food bearing such a labeling claim. If, upon further experience with the rule, we find that it would be helpful to issue additional guidance, whether such guidance would be directed at industry or at FDA itself (such as discussion of a new test method), we will consider developing such guidance.

(Comment 32) Some comments urged that we fund research to learn more about potential treatment for celiac disease beyond the avoidance of gluten or about oat sensitivity in some people with celiac disease. Other comments suggested we also support research to determine the impact of low levels of gluten in gluten-sensitive individuals.

(Response 32) Although we agree that these issues are of interest to FDA, the funding of any research activities is beyond the scope of this rulemaking. The final rule is limited to defining the term “gluten-free” and to describing how such a claim is permitted in the labeling of foods.

(Comment 33) Several comments expressed concerns about foods containing some level of gluten due to contact with gluten sources (i.e., through cross-contact), and suggested that we require specific manufacturing conditions for foods bearing a “gluten-free” claim. In the context of this rule, cross-contact occurs when a food without gluten comes in contact with a gluten-containing food or ingredient, resulting in the presence of gluten in the food not intended to contain gluten. The comments suggested that multi-product facilities do not have sufficient means to minimize the introduction of gluten in products and therefore believed that these foods could not be without gluten. The comments suggested the use of dedicated facilities or dedicated production lines to exclude the unavoidable contact with gluten with foods bearing a “gluten-free” claim.

Some comments were particularly concerned that foods inherently free of gluten (e.g., rice or dried fruits) could be processed in facilities or on equipment that also manufacture gluten-containing foods. Because of cross-contact concerns, these comments requested that we require foods bearing a “gluten-free” claim to be manufactured on equipment or in facilities that only produce foods that are inherently free of gluten. Some comments asked that we require, when appropriate, that foods labeled “gluten-free” also disclose on the label that they were not produced in dedicated facilities (i.e. “this food manufactured in a facility that also processes foods containing gluten”). However, many other comments said these additional label declarations would be useless and frustrating to individuals with celiac disease who are seeking foods for their gluten-free diets. Still other comments noted that products can be produced in mixed product facilities and still comply with the final rule's definitions and requirements through the use of controls designed to avoid cross-contact of foods with gluten sources during food manufacturing.

(Response 33) We agree with the comments stating that manufacturers that adhere to specific manufacturing practices that can prevent gluten cross-contact situations can produce foods that meet the final rule's definition of “gluten-free.” The < 20 ppm level is only one of the criteria used to define “gluten free.” We determined that this level is appropriate, enforceable, practical, and protective of the public health. We expect foods bearing the “gluten-free” claim to be manufactured using whatever controls are necessary to prevent cross-contact with all gluten sources and to ensure that any amount of gluten that may be present in the food from cross-contact is as low as possible and that the food has less than 20 ppm gluten.

We disagree with comments asking us to require labels to disclose whether foods are not produced in dedicated facilities or on dedicated equipment because such a disclosure would suggest that those foods have necessarily come in contact with gluten and do not comply with the definition of “gluten-free.” Nevertheless, manufacturers may disclose voluntarily whether their foods are produced in dedicated facilities or on dedicated equipment, provided that such statements are truthful and non-misleading.

We also disagree with comments requesting that we require foods bearing a “gluten-free” claim be manufactured on dedicated equipment or in dedicated facilities because limitations due to cost, equipment utilization needs, and space would make it impractical for many manufacturers to produce gluten-free foods. Some data show that large companies are more likely than their medium-size or small-size counterparts to dedicate facilities to avoid cross-contact (Ref. 38). Facilities should be able to avoid cross-contact during production by using, for example, physical barriers (such as walls, curtains, or distance) or air handling as a means of isolating the production line and by cleaning and sanitation of equipment between production runs. Also, the requirement sought by the comments likely would discourage manufacturers from labeling their products as “gluten-free” and result in fewer foods labeled “gluten-free” available for persons with celiac disease.

Accordingly, the final rule does not require foods bearing a “gluten-free” claim to be manufactured in dedicated facilities or on dedicated equipment, or require any form of disclosure on the label that the foods were not produced in dedicated facilities or on dedicated equipment. We expect these facilities to take proper precautions to reduce the potential for cross-contact of food, food ingredients, food-contact surfaces, finished foods, or food-packaging materials from gluten sources. The potential for this cross-contact may be reduced by adequate controls and operating practices, effective design, and the separation of operations in which such contact is likely to occur, by one or more of the following means: Location, time, partition, air flow, enclosed systems, cleaning and sanitation, or other effective means.

(Comment 34) Several comments urged us to strictly enforce our rule to ensure that foods bearing a “gluten-free” claim comply with the final rule.

(Response 34) We enforce our regulations primarily through inspections of food processing facilities, examination of imports, collection and testing of food products on the market, and imposition of enforcement measures as required to protect consumers. Manufacturers are responsible for ensuring that food bearing a “gluten-free” claim is not misbranded for failure to meet the final rule.

(Comment 35) One comment asked how we will enforce the rule against foods already in the marketplace. The comment explained the concern that the consumer will not be able to trust the labeling initially and the rule will be less effective than anticipated.

(Response 35) The final rule becomes effective on September 4, 2013. We recognize that manufacturers of foods currently bearing a “gluten-free” claim may need time to review their products to ensure that these foods comply with this final rule, or to remove “gluten-free” or similar claims from the label if their foods do not comply. Consequently, we are establishing a compliance date of August 5, 2014.

Although we are issuing the final rule after January 1, 2013, there is sufficient justification for establishing the compliance date of August 5, 2014, to enforce the provisions of this final rule, rather than January 1, 2016, which FDA established as the next uniform compliance date for other food labeling changes for food labeling regulations issued between January 1, 2013, and December 31, 2014 (77 FR 70885; November 28, 2012).

We believe that 12 months from the date of publication is sufficient time for manufacturers to review their products to ensure that these foods comply with this final rule, or to remove “gluten-free” or similar claims from the label if their foods do not comply. This period of 12 months is consistent with what FDA has used in the past for compliance with the requirements of voluntary food labeling claims. We believe that waiting until FDA's next uniform compliance date of January 1, 2016, would create an unnecessary delay in the enforcement of this final rule, as foods bearing the voluntary label claim “gluten-free” that do not comply with FDA's regulatory definition of “gluten-free” could have an adverse public health impact on persons with celiac disease who may be consuming those foods.

Therefore, we are establishing the compliance date to enforce the provisions of this final rule at August 5, 2014. By that time, manufacturers of foods labeled with the “gluten-free” claim must comply with the requirements of the final rule.

In the interim, if manufacturers want to use stickers as a short-term measure to amend their labels, we would not object provided that the stickered products are in compliance with all of FDA's labeling requirements. If a manufacturer chooses this option, the sticker should adhere to the package under customary storage conditions throughout the shelf life of the product, and the corrected label must comply with all applicable laws and regulations.

(Comment 36) Some comments expressed concern that distilled vinegar, as a food product or ingredient, could contain gluten. The comments said we should not allow distilled vinegar to be labeled as “gluten-free.” Other comments expressed concern about gluten in malt vinegar and malt extract. One comment stated that information contained in the preamble to the proposed rule is contradictory regarding malt vinegar and malt extract. The comment noted that, in some places, the preamble to the proposed rule listed these foods together with wheat starch. The comment said that listing malt vinegar and malt extract with wheat starch could create the misimpression that malt vinegar and malt extract have been processed to remove gluten.

(Response 36) As the comments suggest, there are different types of vinegars. For example, there is distilled vinegar (also known as spirit vinegar or grain vinegar) and other vinegars that are not distilled like cider vinegar (also known as apple vinegar or simply “vinegar”), wine vinegar (also known as grape vinegar), malt vinegar, sugar vinegar, and glucose vinegar to mention a few. All vinegars undergo a fermentation process during their production, but can be derived from different substances. For example, cider vinegar is made by the alcoholic and subsequent acetous fermentations of the juice of apples; whereas, wine vinegar is made by the alcoholic and subsequent acetous fermentations of the juice of grapes. In addition, as the comments noted, some vinegars may be made from gluten-containing grains, such as malt vinegar, which is the product made by the alcoholic and subsequent acetous fermentations, without distillation, of an infusion of barley malt or cereals whose starch has been converted by malt. For a fuller discussion see Food and Drug Administration, Compliance Policy Guide Sec. 525.825, “Vinegar, Definitions—Adulteration With Vinegar Eels” (available at http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074471.htm ).

As we indicated in our response to comment 14, we intend to issue a proposed rule to address how FDA will evaluate compliance with § 101.91(b) when an evaluation of compliance based on an analysis of the food using a scientifically valid method under § 101.91(c) is not available because the food is fermented or hydrolyzed or contains fermented or hydrolyzed ingredients.

We intend to consider the comments received on vinegars, including distilled vinegar, in that proposed rule.

(Comment 37) Many comments urged FDA to coordinate with the U.S. Department of Agriculture (USDA) so that FDA and USDA have the same standard for foods labeled “gluten-free.” Other comments indicated that the same definition of “gluten-free” should apply to all foods and that “gluten-free” labeling of foods should be mandatory and not voluntary to be protective of individuals with celiac disease.

(Response 37) We have been in contact with both the Food Safety and Inspection Service (FSIS, which is an Agency within USDA) and TTB concerning our gluten-free rulemaking and related issues. USDA regulates the labeling of all poultry, most meats, and certain egg products, and TTB regulates the labeling of most alcoholic beverages. We expect to continue working with both FSIS and TTB on matters relating to use of the term “gluten-free.”

Regarding the comments to make gluten-free labeling “mandatory,” section 206 of FALCPA directed us to establish a definition for the term “gluten-free” and “permit” use of this term in the labeling of food. We consider the use of the word “permit” instead of “require,” to mean that manufacturers may, but are not required to, label their food products “gluten-free” provided that they comply with our rule.

We received no comments on the legal basis, as set forth in the proposed rule, to define the term “gluten free” for voluntary use in the labeling of foods.

Consistent with section 206 of FALCPA and sections 403(a)(1), 201(n), and 701(a) of the FD&C Act, we are issuing requirements for the use of the term “gluten free” for voluntary use in the labeling of foods. A food bearing the claim “gluten-free” that does not conform to the requirements in the final rule would result in the food being misbranded within the meaning of sections 403(a)(1) and 201(n) of the FD&C Act.

We include requirements in § 101.91(b)(2) of the final rule for the use of the terms “no gluten,” “free of gluten,” and “without gluten” in the labeling of food in order for such food to not be misbranded under sections 403(a)(1) and 201(n) of the FD&C Act. Specifically, food that bears such a claim in labeling must meet the requirements for the use of the “gluten-free” claim because the use of “no,” “free of,” and “without” gluten connote the same meaning to consumers as “gluten-free” (Ref. 32). Thus, it would be misleading to consumers to use such terms if the food bearing the claim did not meet the same requirements as a food bearing a “gluten-free” claim.

In addition, § 101.91(b)(3) of the final rule requires a food that bears a “gluten-free” claim (as well as a “no gluten,” “free of gluten,” or “without gluten” claim) in addition to a statement regarding wheat content on the label required by section 403(w) of the FD&C Act, to also bear additional language to clarify that the wheat has been processed to allow this food to meet FDA requirements for a gluten-free food in order for the food not to be misbranded under sections 403(a)(1) and 201(n) of the FD&C Act. Because consumers would see two seemingly contradictory terms in the labeling based on separate statutory and regulatory requirements for each, this additional language is necessary to prevent consumers from being misled (Ref. 32).

The legal basis for federal preemption is discussed in the Federalism section, section VII.

FDA has examined the impacts of this final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We have developed a detailed Regulatory Impact Analysis (RIA) that presents the benefits and costs of this final rule (Ref. 39) which is available at http://www.regulations.gov (enter Docket No. FDA-2005-N-0404). The full economic impact analyses of FDA regulations are no longer (as of April 2012) published in the Federal Register but are submitted to the docket and are available at http://www.regulations.gov. We believe that the final rule is a significant regulatory action as defined by Executive Order 12866.

The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Additional costs per entity of this final rule are small, but not negligible, and as a result we conclude that the final rule could have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $141 million, using the most current (2012) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount.

The analyses that we have performed to examine the impacts of this final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act, and the Unfunded Mandates Reform Act of 1995 are included in the RIA (Ref. 39).

We conclude that the labeling provisions of this final rule set forth in this document are not subject to review by the Office of Management and Budget because they do not constitute a “collection of information” under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Rather, the “gluten-free” labeling claims are “public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public” (5 CFR 1320.3(c)(2)).

We have determined under 21 CFR 25.30(h) and (k) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

We have analyzed the final rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of Executive Order 13132 requires Agencies to “construe . . . a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” Here, we have determined that certain narrow exercises of State authority would conflict with the exercise of Federal authority under the FD&C Act.

In section 206 of FALCPA, Congress directed us to issue a proposed rule to define and permit use of the term “gluten-free” on the labeling of foods, in consultation with appropriate experts and stakeholders, to be followed by a final rule for the use of such term in labeling. In the preamble to the proposed rule (72 FR 2795 at 2813 through 2814), we proposed preemption of State requirements and indicated that we had consulted with numerous experts and stakeholders in the proposed rule's development. Different and inconsistent amounts of gluten in foods with “gluten-free” labeling result in the inability of those individuals with celiac disease who adhere to a gluten-free diet to avoid exposure to gluten at levels that may result in adverse health effects. There is a need for national uniformity in the meaning of the term “gluten-free” so that most individuals with celiac disease can make informed purchasing decisions that will enable them to adhere to a diet they can tolerate without causing adverse health effects and can select from a variety of available gluten-free foods. If States were able to establish different definitions of the term “gluten-free,” then individuals with celiac disease would not be able to rely on that term to understand the amount of gluten the food may contain and thereby use the term to identify appropriate dietary selections. As a result, individuals with celiac disease may unnecessarily limit their food choices, or conversely, select foods with levels of gluten that are not tolerated and that may cause adverse health effects. Food manufacturers, if confronted by a State or various State requirements that adopted a different gluten threshold than what the final rule establishes, might decide to remove the “gluten-free” label, and such a result would make it more difficult for individuals with celiac disease to identify foods that they can tolerate and achieve a dietary intake from a variety of foods to meet an individual's nutrient needs. Moreover, a consistent definition of “gluten-free” enables the Agency to more efficiently enforce the definition across all foods through the use of a reliable scientifically valid method to detect gluten and ensure labels bearing a “gluten-free” claim are truthful and not misleading.

Therefore, the objective of this rule is standardizing use of the term “gluten-free” in the labeling of foods so that foods with this claim in labeling, and foods with a claim of “no,” “free of,” and “without” gluten, which connote a similar meaning to that of “gluten free,” are used in a consistent way and will therefore prevent consumer confusion and assist individuals with celiac disease to make purchasing decisions.

Section 4(c) of Executive Order 13132 instructs us to restrict any Federal preemption of State law to the “minimum level necessary to achieve the objectives of the statute pursuant to which the regulations are promulgated.” The final rule meets the preceding requirement because it preempts State law narrowly, only to the extent required to achieve uniform national labeling with respect to the requirements related to the use of the term “gluten-free,” as well as the terms “no gluten,” “free of gluten,” or “without gluten.” As we explain later in this section, we are preempting State or local requirements only to the extent that they are different from the requirements in this section related to the use of the terms “gluten-free,” “no gluten,” “free of gluten,” or “without gluten.” In addition, we cannot foresee every potential State requirement and preemption may arise if a State requirement is found to obstruct the federal purpose articulated in this rule. We do not intend the final rule to preempt other State or local labeling requirements with respect to other statements or warnings about gluten. For example, a State would not be preempted from requiring a statement about the health effects of gluten consumption on persons with celiac disease or information about how the food was processed.

Section 4(d) of Executive Order 13132 states that when an Agency foresees the possibility of a conflict between State law and federally protected interests within the Agency's area of regulatory responsibility, the Agency “shall consult, to the extent practicable, with appropriate State and local officials in an effort to avoid such a conflict.” Section 4(e) of Executive Order 13132 provides that “when an agency proposes to act through adjudication or rulemaking to preempt State law, the agency shall provide all affected State and local officials notice and an opportunity for appropriate participation in the proceedings.” FDA's Division of Federal and State Relations invited the States' participation in this rulemaking by providing notice via fax and email transmission to State health commissioners, State agriculture commissioners, and State food program directors as well as FDA field personnel of the publication of the proposed rule. The notice gave the States further opportunity for input on the rule, advised the States of FDA's possible action, and encouraged State and local governments to provide any comments. We did not receive any comments from State or local authorities.

After we had published the proposed rule in the Federal Register , the President issued a memorandum entitled “Preemption” (74 FR 24693 (May 22, 2009)). The memorandum, among other things, instructs Agencies to “not include in regulatory preambles statements that the department or agency intends to preempt State law through the regulation except where preemption provisions are also included in the codified regulation” and “not include preemption provisions in codified regulations except where such provisions would be justified under legal principles governing preemption, including the principles outlined in Executive Order 13132” (id.).

Because of the May 22, 2009, memorandum and because the final rule differs from the proposed rule in several respects, we explain in detail here the principles underlying our conclusion that the final rule may result in preemption of State and local laws under a narrow set of circumstances and describe the final rule's codified provision regarding preemption.

Under the Supremacy Clause of the Constitution (U.S. Constitution; Art. VI, clause 2), State laws that interfere with or are contrary to Federal law are invalid. (See Gibbons v. Ogden, 22 U.S. (9 Wheat.) 1, 211 (1824).) Federal preemption can be express (stated by Congress in the statute) or implied. Implied preemption can occur in several ways. For example, Federal preemption may be found where Federal law conflicts with State law. Such conflict may be demonstrated either when “compliance with both federal and state [law] is a physical impossibility” ( Florida Lime and Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142-143 (1963)), or when State law “stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress” ( Crosby v. Nat'l Foreign Trade Council, 530 U.S. 363, 372-74 (2000) (citing Hines v. Davidowitz, 312 U.S. 52, 67 (1941))). State law is also preempted if it interferes with the methods by which a Federal law is designed to reach its goals. ( See International Paper Co. v. Ouellette, 479 U.S. 481, 494 (1987); Michigan Canners & Freezers Ass'n v. Agricultural Marketing & Bargaining Bd., 467 U.S. 461, 477-478 (1984).)

Additionally, “ ‘a federal agency acting within the scope of its congressionally delegated authority may preempt state regulation' and hence render unenforceable state or local laws that are otherwise not inconsistent with federal law” ( City of New York v. FCC, 486 U.S. 57, 63-64 (1988) (quoting Louisiana Public Service Comm'n v. FCC, 476 U.S. 355, 369 (1986)). “Federal regulations have no less preemptive effect than federal statutes” ( Fidelity Federal Savings and Loan Ass'n v. de la Cuesta, 458 U.S. 141, 153 (1982)).

When an Agency's intent to preempt is clearly and unambiguously stated, a court's inquiry will be whether the preemptive action is within the scope of that Agency's delegated authority ( Capital Cities Cable, Inc. v. Crisp, 467 U.S. 691, 700 (1984); Fidelity Federal Savings, 458 U.S. at 154). If the Agency's choice to preempt “represents a reasonable accommodation of conflicting policies that were committed to the agency's care by the statute [the regulation will stand] unless it appears from the statute or its legislative history that the accommodation is not one that Congress would have sanctioned” ( United States v. Shimer, 367 U.S. 374, 383 (1961)). In Hillsborough County, the Supreme Court stated that FDA possessed the authority to promulgate regulations preempting local laws that compromise the supply of plasma and could do so ( Hillsborough County, Fla. v. Automated Medical Laboratories, Inc., 471 U.S. 707, 721 (1985)). We believe we have similar authority to preempt State and local laws and regulations to the limited extent that they define and permit use of “gluten- free,” “no gluten,” “free of gluten,” or “without gluten” differently from our final rule because different State or local requirements would be contrary to the Congressional directive for us to define and permit use of the term “gluten-free.”

State or local laws or regulations that define and permit use of “gluten-free,” “no gluten,” “free of gluten,” or “without gluten” differently from our final rule could frustrate the ability of most consumers to identify gluten-free foods and avoid adverse health effects and deter manufacturers from applying a “gluten-free” label to their foods. As discussed previously, currently, individuals with celiac disease do not know what the term “gluten-free” on a product means because there is no consistent or established definition of “gluten-free” in the United States. For example, a product currently labeled gluten-free could contain 10 ppm gluten or 100 ppm gluten. Therefore, consumers with celiac disease cannot have confidence to identify and purchase gluten-free products they can tolerate and that can provide a variety of foods in their diets. With a uniform federal definition, consumers throughout the United States can understand what the term “gluten-free” means on a packaged food. A uniform definition of gluten-free will also allow the Agency to more efficiently enforce the definition on product labels and manufacturers will be able to comply with a single set of requirements which may lead to greater use of this voluntary labeling. Consequently, we have added a new § 101.91(d) entitled “Preemption” to the final rule. Section 101.91(d) declares that a State or political subdivision of a State may not establish or continue into effect any law, rule, regulation, or other requirement that is different from the requirements in § 101.91 for the definition and use of the term “gluten-free,” as well as the terms “no gluten,” “free of gluten,” or “without gluten.” Preemption may also arise with regard to other labeling language regarding gluten if a state requirement is found to obstruct the federal purpose articulated in this rule.

The following references have been placed on display in the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and are available electronically at http://www.regulations.gov. (We have verified all the Web site addresses in the References section, but we are not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register .)

For the reasons discussed in the preamble, the Food and Drug Administration amends 21 CFR part 101 as follows:

On March 14, 2013, the United Nations Security Council adopted resolution 2095 (“UNSCR 2095”), which further modified the arms embargo against Libya put in place by the adoption in February and March of 2011 of resolutions 1970 and 1973, respectively, and modified by resolutions 2009 and 2016, adopted in September and October of 2011, respectively (for previous ITAR amendments regarding Libya defense trade policy, see “Amendment to the International Traffic in Arms Regulations: Libya,” RIN 1400-AC83, 76 FR 30001, and “Amendment to the International Traffic in Arms Regulations: Libya and UNSCR 2009,” RIN 1400-AC97, 76 FR 68313).

UNSCR 2095 removed the requirement for member states to notify the Committee of the Security Council concerning Libya (“the Committee”) of exports of non-lethal military equipment, and the provision of any technical assistance or training, intended solely for security or disarmament assistance to the Libyan government. It also removed the requirement to seek the approval of the Committee for exports of non-lethal military equipment, and related technical assistance or training, for humanitarian and protective use. The Department of State is amending ITAR § 126.1(k) accordingly.

The Department of State is of the opinion that controlling the import and export of defense articles and services is a foreign affairs function of the United States Government and that rules implementing this function are exempt from sections 553 (rulemaking) and 554 (adjudications) of the Administrative Procedure Act. Since the Department is of the opinion that this rule is exempt from 5 U.S.C. 553, it is the view of the Department that the provisions of section 553(d) do not apply to this rulemaking. Therefore, this rule is effective upon publication. The Department also finds that, given the national security issues surrounding U.S. policy towards Libya, notice and public procedure on this rule would be impracticable or unnecessary; for this reason also, this rule is effective upon publication.

Since the Department is of the opinion that this rule is exempt from the provisions of 5 U.S.C. 553, there is no requirement for an analysis under the Regulatory Flexibility Act.

This rulemaking does not involve a mandate that will result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any year and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This rulemaking has been found not to be a major rule within the meaning of the Small Business Regulatory Enforcement Fairness Act of 1996.

This rulemaking will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, it is determined that this rulemaking does not have sufficient federalism implications to require consultations or warrant the preparation of a federalism summary impact statement. The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities do not apply to this rulemaking.

Executive Orders 12866 and 13563 direct agencies to assess costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributed impacts, and equity). These executive orders stress the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated a “significant regulatory action,” although not economically significant, under section 3(f) of Executive Order 12866. Accordingly, this rule has been reviewed by the Office of Management and Budget (OMB).

The Department of State has reviewed this rulemaking in light of sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden.

The Department of State has determined that this rulemaking will not have tribal implications, will not impose substantial direct compliance costs on Indian tribal governments, and will not pre-empt tribal law. Accordingly, the requirements of Executive Order 13175 do not apply to this rulemaking.

This rule does not impose any new reporting or recordkeeping requirements subject to the Paperwork Reduction Act, 44 U.S.C. Chapter 35.

Accordingly, for the reasons set forth above, Title 22, Chapter I, Subchapter M, part 126 is amended as follows:

Today's final rule establishes requirements directing Federal agencies to submit their occupational injury and illness recordkeeping information to the Secretary of Labor which will allow (1) BLS to analyze injury and illness data at Federal establishments, and (2) OSHA to better track injury trends at Federal agencies, and to better target inspections at the most hazardous Federal establishments.

• Revisions to update existing regulatory language: Since the basic program elements were originally published in 1980, changes have occurred that make the existing language out of date.

• The Unites States Postal Service: The Occupational Safety and Health Act of 1970 (OSH Act) was amended to make it applicable to the U.S. Postal Service (USPS) in the same manner as any other private sector employer. Therefore, language in the basic program elements has been modified to indicate that the USPS is not included in the definition of “agency.”

• Financial management: The Office of Management and Budget (OMB) circulars referenced in the original regulations are no longer in use. Therefore the language has been revised to reference only relevant OMB regulations and documents.

• Abatement of unsafe or unhealthful working conditions: Abatement requirements have been changed to follow private sector procedures.

• Records retention: A section of the basic program elements addressing retention and access of employee records was inadvertently deleted in a prior revision and is now being reinserted in this rulemaking.

• Changes are being made to require Federal agencies to annually submit their OSHA required injury and illness data.

• Modifying dates to reflect the collection of calendar year data, rather than fiscal year data: We have modified the due date when Federal agencies must submit their annual report on safety and health to OSHA, and the report from OSHA to the President, to allow for the use of OSHA required injury and illness data.

• Submission of the OSHA required injury and illness data: We are stipulating that the Secretary of Labor will be collecting the OSHA required injury/illness data annually. Clarification is also provided on how to identify the injuries/illnesses of volunteers, the calculation of the total number of hours worked by uncompensated volunteers, and that OMB job series numbers should be used to identify job titles.

This final rule is organized as follows:

Section 19 of the Occupational Safety and Health Act (the “OSH Act”) (29 U.S.C. 668) includes provisions to ensure safe and healthful working conditions for Federal sector employees. Under that section, each Federal agency is responsible for establishing and maintaining an effective and comprehensive occupational safety and health program consistent with the standards promulgated by OSHA under Section 6 of the OSH Act. Executive Order 12196, Occupational Safety and Health Programs for Federal Employees, issued February 26, 1980, prescribes additional responsibilities for the heads of Federal agencies, the Secretary of Labor, and the General Services Administration. Among other things, the Secretary of Labor, through OSHA, is required to issue basic program elements with which the heads of agencies must operate their safety and health programs. These basic program elements are set forth at 29 CFR Part 1960. Section 19 of the OSH Act, the Executive Order, and the basic program elements under 29 CFR Part 1960 apply to all agencies of the Executive Branch except military personnel and uniquely military equipment, systems, and operations.

Pursuant to Section 19(a) of the OSH Act, each head of a Federal agency is responsible for keeping adequate records of all occupational injuries and illnesses. Section 1-401(d) of Executive Order 12196 provides the Secretary with authority to prescribe recordkeeping and reporting requirements for Federal agencies. On October 21, 1980, OSHA issued a final rule addressing Federal agency safety and health programs which included occupational injury and illness recordkeeping requirements at 29 CFR Part 1960, Subpart I, Recordkeeping and Reporting Requirements, (45 FR 69796).

On January 19, 2001, OSHA issued a revised system of injury and illness recordkeeping requirements for private sector employers at 29 CFR Part 1904, (66 FR 5916). The revised recordkeeping rules were designed, among other things, to provide better information about the incidence of occupational injuries and illnesses; simplify the recordkeeping system for employers; promote improved employee awareness and involvement in the recording and reporting of injuries and illness; and permit the increased use of computers and telecommunications in carrying out OSHA-required recordkeeping.

By 2004, it was clear to OSHA that significant inconsistencies existed between the private sector and the Federal Government's recording and tracking of occupational injuries and illnesses. In order to make the private sector and Federal sector systems consistent, OSHA, on November 26, 2004, issued a final rule to amend the occupational injury and illness recordkeeping requirements applicable to Federal agencies, (69 FR 68793). OSHA's final rule adopted applicable provisions of 29 CFR Part 1904, which made the recording and reporting requirements for the Federal sector essentially identical to those for the private sector.

OSHA's regulation at 29 CFR 1904, Recording and Reporting Occupational Injuries and Illnesses, was one of the first regulations promulgated by OSHA. First issued in 1971, this regulation requires employers to record information on the occurrence of injuries and illnesses in their workplaces if the injuries and illnesses meet one or more of certain recording criteria. In accordance with the OSH Act, OSHA requires employers to record work-related injuries and illnesses that involve death, loss of consciousness, days away from work, restricted work activity or job transfer, medical treatment beyond first aid, or diagnosis of a significant injury or illness by a physician or other licensed health care professional.

The OSHA recordkeeping system consists of three forms. First, employers must maintain a log (OSHA Form 300, commonly referred to as the “OSHA log,” or an equivalent form) that lists each injury and illness that occurred in each establishment during the year. The log is available to employees, former employees, and their representatives. For each case on the log, the employer also prepares a supplementary record (OSHA Form 301, or an equivalent), that provides additional details about the injury or illness. A summary of the log (OSHA Form 300A, or an equivalent) is prepared by the employer and posted in the workplace from February 1 to April 30 of the year following the year to which the records pertain. As noted in the November 2004 recordkeeping final rule, Federal agencies may choose to use the Office of Workers' Compensation Program (OWCP) Forms CA-1, CA-2 and CA-6  1 for the purpose of complying with OSHA's recordkeeping requirements (excluding contractors), as long as Federal agencies include the additional OSHA-required information for the OSHA 301 form. If agencies use these forms for OSHA recordkeeping requirements, they must ensure all OSHA required fields on these forms are complete, whether or not they are required by OWCP.

Occupational injury and illness records, and the statistics based on them, have several desired functions or uses. One use is to provide information to employers and employees about the kinds of injuries and illnesses occurring in the workplace, and the hazards that cause or contribute to them. Injury and illness statistics play an important role in shaping an employer's injury and illness prevention program, and investigation into patterns of injuries can provide information useful in abating hazards and preventing additional injuries from occurring.

The records are also an important source of information for OSHA. During the initial stages of an inspection, an OSHA representative reviews the recordkeeping data for the establishment as an aid to focusing the inspection effort on safety and health hazards. OSHA also uses establishment- specific injury and illness information to help target its intervention efforts on the most dangerous worksites. Injury and illness statistics help OSHA identify the scope of occupational safety and health problems and decide whether regulatory intervention, compliance assistance, or other measures are warranted.

Finally, the records required by the OSHA recordkeeping regulation are the source of information for the BLS-generated national statistics on workplace injuries and illnesses, including information on the source, nature, and type of these injuries and illnesses. BLS makes the aggregate information available both for research purposes and for public information. BLS has published occupational safety and health statistics since 1971, and this information charts the magnitude and nature of injury and illness problems across the country.

In the private sector, OSHA has long had in place rules pertaining to Agency access to information concerning worker safety and health. Section 8 of the OSH Act provides OSHA with the authority to issue regulations and standards requiring employers to make, keep and preserve, and make available to OSHA, records relating to the OSH Act. OSHA's regulation at 29 CFR 1910.1020, Access to employee exposure and medical records, provides access to exposure and medical records to employees, their designated representatives, and OSHA. Several of OSHA's substance-specific health standards, such as those for occupational exposure to benzene and lead, include requirements for employee and OSHA access to information required to be maintained by those standards.

With respect to OSHA injury and illness recordkeeping, Section 1904.40 requires employers to provide a complete copy of records kept under Part 1904 to an authorized government representative when the representative asks for such records during a workplace safety and health inspection. Section 1904.40(b)(1) states that authorized government representatives who have a right to obtain Part 1904 records are a representative of the Secretary of Labor conducting an inspection or investigation under the OSH Act, a representative of the Secretary of Health and Human Services (including the National Institute for Occupational Safety and Health (NIOSH) conducting an investigation under Section 20(b) of the OSH Act, or a representative of a State agency responsible for administering a State plan under Section 18 of the OSH Act.

Section 8(c) of the OSH Act also gives the Secretary the authority to prescribe regulations requiring employers to make periodic reports on work-related deaths, injuries and illnesses. For purposes of OSHA injury and illness recordkeeping, periodic reporting from a subset of employers is accomplished through the OSHA Data Initiative (ODI), and the Annual Survey of Occupational Injuries and Illnesses conducted by BLS. Although OSHA and BLS collect injury and illness information, collection of the information is conducted through different means and used for different purposes.

Under Section 1904.41, each year OSHA sends injury and illness survey forms to employers in certain high-hazard industries. In any year, some employers will receive a survey form, and others will not. Employers are not required to send injury and illness recordkeeping information to OSHA unless they receive a survey form.

Employers that receive a survey form submit information on the number of workers employed, the number of hours worked by employees, and requested information from records created and maintained under Part 1904. The information produced from the survey includes incidence rates, as well as the number of occupational injuries and illnesses. Incidence rates relate the number of injuries and illnesses to a common base of exposure. The rate shows the number of injuries and illnesses per 100 workers. This common base allows for accurate cross-industry comparisons, trend analysis over time and comparisons among firms regardless of size. The establishment-specific data collected by OSHA are used to administer OSHA's various programs and to measure the performance of those programs at individual workplaces.

Section 1904.42 establishes requirements for employers, when asked, to complete and submit an annual survey from BLS. BLS collects data from a statistical sample of employers in all industries and across all size classes, using the data to compile occupational injury and illness statistics for the Nation. BLS gives each respondent a pledge of confidentiality (as it does on all BLS surveys), and the establishment-specific injury and illness data are not shared with the public, OSHA or other government agencies.

Section 19 of the OSH Act provides the Secretary of Labor with access to occupational injury and illness records and reports kept and filed by Federal agencies “unless those records and reports are specifically required by Executive Order to be kept secret in the interest of the national defense or foreign policy, in which case the Secretary of Labor shall have access to such information as will not jeopardize national defense or foreign policy.” Section I-201(j) of Executive Order 12196 requires the head of each agency to operate an occupational safety and health management information system, which includes the maintenance of records required by the Secretary of Labor. Section I-201(l) also requires the head of each agency to submit to the Secretary of Labor an annual report on the agency occupational safety and health program that includes information the Secretary prescribes. Section 401(d) of the Executive Order states that the Secretary of Labor shall prescribe recordkeeping and reporting requirements.

Today's final rule establishes requirements directing Federal agencies to submit their occupational injury and illness recordkeeping information to the Secretary. The final rule does not require Federal agencies to create or maintain any new records. Instead, the final rule amends the basic program elements at 29 CFR part 1960 by adding § 1960.72, and requires Federal agencies to submit information included on the three OSHA recordkeeping forms to BLS. BLS will then electronically transmit the data from these forms to OSHA.

Under the final rule, by May 1 of each year, Federal agencies must submit their injury and illness recordkeeping data from the previous calendar year directly to BLS. The May 1 deadline for submission of the previous calendar year's information is based on the posting requirements in § 1904.32. That Section requires employers to post their Annual Summary from the previous calendar year from February 1 through April 30. During the posting period, employees have the opportunity to review the information, and this review may result in new or revised entries about injuries and illnesses at the establishment. Therefore, the May 1 submission deadline should allow for the submission of more accurate and complete recordkeeping information.

BLS is leading the collection effort established by today's final rule because it already has a system in place to collect injury and illness data from the private sector. However, the final rule includes two important differences from the private sector data collection system. First, unlike the private sector collection effort, which is a statistical sample, today's final rule requires the submission of all Federal agency injury and illness data from each Federal establishment. Second, unlike the private sector BLS survey, which is conducted solely for statistical purposes and not shared with OSHA, the BLS collection of federal agency data from the OSHA forms will be electronically transmitted to OSHA.

Individually identifiable information will not be made public. Establishment data will not be published if such information will result in a breach of employee privacy. DOL will carefully review all information before it is released, to ensure that privacy is not violated.

The submitted information will be used by BLS when developing and analyzing Federal Government injury and illness statistics. In the private sector and State and local government, BLS collects injury and illness data from employers through the Annual Survey of Occupational Injuries and Illnesses. An employer selected by BLS to participate in the Annual Survey must provide information about employee injuries and illnesses recorded on the employer's OSHA forms. BLS collects the information from a statistical sample in all industries and across all size classes, and uses the data to estimate the number of work-related injuries and illnesses across the Nation, as well as a measure of the frequency (rate) at which they occur. The BLS survey, which is conducted solely for statistical purposes, is not directly related to OSHA's enforcement of workplace safety and health requirements.

BLS will use the data required to be submitted by today's final rule to calculate injury and illness incidence rates for the Federal sector. BLS develops incidence rates by industry, establishment size, and many other case types, and Federal agencies will be able to compare their incidence rates with national averages for similar types of organizations. The information will be aggregated from other Federal agencies and similar establishments in the private sector and State and local government to identify injury and illness patterns among industries and occupations.

OSHA will use the submitted information for a variety of purposes, including targeting of Federal workplaces for OSHA inspection; deployment of resources for safety and health training; periodic assessment of the basic program elements; development of information for promulgating, revising or evaluating OSHA standards and regulations; evaluating and analyzing Presidential initiatives addressing injury and illness rate reduction in the Federal Government; and OSHA evaluations. By using the establishment-specific information, OSHA will be able to more effectively allocate its resources to focus on the most hazardous Federal establishments.

In the past, OSHA used statistical data provided by the OWCP to target safety and health inspections of Federal agency workplaces. However, the OWCP data is based on whether a case is compensable, and not on whether a case is recordable under OSHA's injury and illness recordkeeping system. Because OSHA has relied on OWCP statistical data, the Agency has not had an effective means of identifying and targeting the most hazardous Federal establishments for comprehensive safety and health inspection. On the other hand, occupational injury and illness records provide safety and health information about specific Federal establishments, including information about the location, equipment, materials or chemicals used at the time of an injury or illness.

Moreover, OSHA uses injury and illness recordkeeping information collected from the OSHA Data Initiative (ODI) when it targets private sector employers for safety and health inspection. By analyzing the recordkeeping data required to be submitted by today's final rule, OSHA will be relying on the same type of information for targeting Federal establishments as it currently uses to make such determinations in the private sector.

OSHA also intends to incorporate the collected information into the Secretary of Labor's Annual Report to the President on Federal Agency Safety and Health. Section 19(a)(5) of the OSH Act and Executive Order 12196 require Federal agencies to make an annual report to the Secretary on occupational accidents and injuries, as well as the Federal agency's program for providing safe and healthful places and conditions of employment. The OSH Act and Executive Order also direct the Secretary to submit an annual summary report to the President on the status of Federal agency occupational safety and health. Historically, when preparing the report for the President, OSHA has included information furnished by OWCP when compiling statistical data concerning Federal agency injury and illness case rates and lost time case rates. In the future, OSHA intends to use the occupational safety and health related data collected from the submitted data when preparing the annual report for the President.

Under the final rule, Federal agencies will submit their injury and illness data using BLS internet data collection facilities. At present, Federal agencies have three options for submitting their OSHA injury and illness recordkeeping information. First, Federal agencies may submit their annual data securely through an internet system with individual password protection, as about 80 percent of the private- and governmental-establishments do today. Second, Federal agencies with existing electronic recordkeeping data collection systems can be provided with a file structure and file transfer protocol to allow them to transmit all of their injury and illness information to BLS. Finally, Federal agencies without existing electronic recordkeeping systems may choose to receive a database structure from the Department of Labor they can use to collect and track their OSHA recordable injuries and illnesses. The current available database structure, known as ECOMP, will require Federal agencies to electronically file their OWCP CA-1 and CA-2 forms. In addition, it will allow Federal agencies to generate their own injury and illness recordkeeping forms. Those agencies may then use the BLS internet system or, like the second option, use a file structure and file transfer protocol to electronically transmit the data to BLS through ECOMP.

BLS collects injury and illness data from private sector employers and state and local governments under a pledge of confidentiality in accordance with Confidential Information Protection and Statistical Efficiency Act of 2002 (CIPSEA), Title 5 of Public Law 107-347, and other applicable Federal law. This pledge of confidentiality does not extend to Federal agencies. BLS will electronically transfer Federal agency data from the OSHA forms to OSHA annually, after the end of each collection cycle.

OSHA intends to develop specific instructions and guidance for Federal agencies, which will be issued annually through written memoranda, on how to submit the data to BLS using the available options. OSHA also intends to develop and maintain a page on its Web site listing the options for submitting the information, as well as specific instructions and guidance included in the annual memorandum to Federal agencies. The annual memorandum and Web page will also serve to notify Federal agencies about the development of new technologies or options for submitting injury and illness information.

Section 1904.46 of OSHA's private sector recordkeeping regulation includes a definition of the term “establishment.” When the injury and illness recordkeeping requirements for Federal agencies were revised in November 2004, OSHA did not incorporate the Part 1904 definition of establishment. Instead, OSHA retained the definition of establishment for Federal agencies in 29 CFR 1960.2(h).

The term “establishment” is defined at 29 CFR 1960.2(h) as “a single physical location where business is conducted or where services or operations are performed. Where distinctly separate activities are performed at a single physical location, each activity is to be treated as a separate establishment. Typically, the term establishment refers to a field activity, regional office, area office, installation, or facility.”

Federal agencies are responsible for keeping a separate OSHA 300 Log (or equivalent), and preparing a single OSHA 300-A Annual Summary for each establishment. (They are also required to keep case details on the OSHA 301 form.) Establishment-specific records are a key component of the recordkeeping system because each separate record represents the injury and illness experience of a given location, and therefore reflects the particular circumstances and hazards that led to the injuries and illnesses at that workplace.

Since 2004, some uncertainty has developed concerning the definition of establishment and its application to Federal agencies. Federal agencies face unique challenges in determining whether specific workplaces meet the definition of “establishment” in § 1960.2(h). For example, in some cases, a single Federal building may house several different Federal agencies, which in turn may have several sub-agencies, divisions or offices. Federal agencies may also establish temporary or short-term offices or workplaces during a given year. In addition, Federal employees may work at multiple locations, at a regional or satellite office, or from home.

For Federal agency OSHA recordkeeping, major organizational units with distinct lines of authority are considered separate establishments. Each Federal department has an organizational structure consisting of agencies, bureaus, or other components that come under the line of authority of an Assistant Secretary, Under Secretary, Assistant Administrator, or similar level. These agencies, bureaus or components are considered major organizational units of a department.

The definition of establishment for Federal agencies at 29 CFR 1960.2(h) includes the phrase: “where distinctly separate activities are performed at a single physical location.” This definition means that each major organizational unit, such as agencies, bureaus or similar components within a Department, is considered an establishment, even if they occupy the same building. For example, the OSHA, the Employment and Training Administration and the Employee Benefits Security Administration are all agencies within the Department of Labor (DOL), and are housed in DOL's Frances Perkins Building. Even though they occupy the same building, these agencies are considered separate establishments for OSHA recordkeeping. This analysis would apply to major organizational units within national, regional or area buildings.

On the other hand, lower organizational units or offices within an agency or bureau located at the same physical location are not separate establishments. For example, the Directorate of Enforcement Programs and Office of Occupational Medicine are both OSHA units located in the DOL Frances Perkins Building, but they are not major organizational units, and therefore are not considered separate establishments.

Other individual Federal agency workplaces with separate physical locations would also be considered separate establishments. For example, OSHA has Regional and Area offices in cities throughout the United States. Even though the Regional and Area offices are part of a major organizational unit (i.e., OSHA), since these offices are at separate locations, they would each be considered a separate establishment. Likewise, Federal agencies with several physical locations within the same city or geographic region are separate establishments. For example, the Civil Rights Division within the U.S. Department of Justice (DOJ) has offices in various buildings located several miles apart in Washington, DC. Even though the offices are all within the same agency (i.e., the Civil Rights Division of DOJ), because they are at separate physical locations, they would be considered separate establishments for OSHA recordkeeping purposes.

Section 1904.30 addresses the procedures to be followed when recording injuries and illnesses occurring in separate establishments operated by the same employer. Section 1904.30(a) states that employers are required to keep separate OSHA 300 Logs for each establishment expected to be in operation for one year or longer. Section 1904.30(b)(1) provides that for short-term establishments, i.e., those that will exist for less than one year, employers are required to keep injury and illness records, but are not required to keep separate OSHA 300 Logs. Instead, employers may keep one OSHA 300 Log covering all short-term establishments, or they may include the short-term establishment records in logs that cover individual company divisions or geographic regions. Federal agencies have the same option when recording injuries and illnesses at short-term establishments.

In some cases, Federal employees work at several different locations, or do not work at any establishment. Section 1904.30(b)(3) provides that each employee must be linked, for recordkeeping purposes, to one of the employer's establishments. This means that all of the employee's injuries or illnesses must be recorded on either his or her home establishment's OSHA 300 Log, or on a general OSHA 300 Log for short-term establishments. The provision ensures that all employees are included in a Federal agency's records.

Under Section 1904.30(b)(4), if an employee is injured or made ill while visiting or working at another of the employer's establishments, then the injury or illness must be recorded on the 300 Log of the establishment where the injury or illness occurred. For the vast majority of cases, the place where the injury or illness occurred is the most useful recording location. (See 66 FR6037). The events or exposures that caused the case are most likely to be present at that location, so the data are most useful for analysis of that location's records. If cases were always recorded at the employee's home base, the injury or illness information would be disconnected from the place where the event or exposure took place, and where analysis of the data may help reveal a workplace hazard. Of course, if the injury or illness occurs at another employer's workplace, or while the employee is in transit, the case would be recorded on the OSHA 300 Log of the employee's home establishment.

For Federal agency recordkeeping purposes, each Department or Bureau is considered the Federal employee's employer, and injuries or illnesses occurring at other Federal Department facilities would be recorded on the employee's home establishment's OSHA 300 Log. For example, if an employee of the Department of Labor is either visiting, or working under the supervision of his or her own agency at a Department of Justice facility, and is injured or made ill, the case would be recorded on the employee's home DOL establishment OSHA 300 Log. Of course, as discussed above, if the DOL employee in this example is being supervised by DOJ employees on a day-to-day basis, and is injured or made ill, the case would be recorded on the DOJ's establishment log.

Injuries and illnesses occurring at facilities operated by the same Department would be recorded on the OSHA Log where the injury or illness took place. For example, if an employee from DOL/OSHA were either visiting or working at a DOL/Mine Safety and Health Administration (MSHA) facility, and was injured or made ill, the case would be recorded on the DOL/MSHA Log. Again, in this example, since the Department of Labor is considered the OSHA employee's employer, the case would be recorded on the log where the injury or illness took place.

When a Federal employee telecommutes, the employee's home is not a separate establishment for recordkeeping purposes, and a separate OSHA 300 Log is not required. For these workers, the worker's establishment is the office to which they report, receive direction or supervision, collect pay, and otherwise stay in contact with their agency, and it is at this establishment where the log is kept.

Agencies should keep in mind that injuries/illnesses that take place while an employee is working from home are not automatically presumed work-related. Work-relationship must be established by demonstrating that the employee's work activity is a discernible cause of the injury/illness.

Section 1904.5(b)(7) addresses the work-relatedness of injuries/illnesses that take place at home. When an employee is working from home on federal agency business, and reports an injury/illness to his or her supervisor, and the employee's work activity caused or contributed to the injury/illness, the case is considered work-related and must be further evaluated to determine whether the case meets any of the recording criteria (i.e., the injury resulted in medical treatment, days away from work, work restrictions etc.). If the injury/illness at home is related to non-work activities, or the general home environment, the case is not work-related. See, the preamble to the final rule revising OSHA's recordkeeping regulation 66 FR 5915 at 5962 for examples of injuries/illnesses at home that are work-related and non-work-related.

In order to effectively target Federal workplaces for safety and health inspection, OSHA needs to be able to identify, collect, and track the injury and illness data from each Federal establishment. Today's final rule adds a new basic program element at 29 CFR 1960.72(c) to require each Federal agency to provide OSHA with a comprehensive listing of their establishments, as defined by 29 CFR 1960.2(h), by May 1, 2014. The list must include the department/agency affiliation, a street address, city, state and zip code for each establishment. Federal agencies are also responsible for updating the list when they submit their annual report to the Secretary on occupational safety and health.

The new basic program element at § 1960.72(c) also requires Federal agencies to provide the North American Industry Classification System (NAICS) code for each of the establishments included on their list. NAICS is the standard used by Federal statistical agencies in classifying business establishments for the purpose of collecting, analyzing, and publishing statistical data related to the U.S. economy. NAICS was developed under the auspices of the Office of Management and Budget (OMB), and adopted in 1997 to replace the Standard Industrial Classification (SIC) system. It was developed jointly by the United States, Canada, and Mexico to allow for a high level of compatibility in business statistics among the North American countries.

The NAICS information will be used by BLS to compile and analyze injury and illness statistical information for the Federal sector. The NAICS information is also important for OSHA and BLS when comparing Federal agency injury and illness information with the private sector or State and local government.

Federal agencies should determine NAICS codes based on the activities in their given establishments. As noted in the NAICS Manual, “In general, ownership is not a criterion for classification in NAICS. Therefore, government establishments engaged in the production of private-sector-like goods and services should be classified in the same industry as private-sector-establishments engaged in similar activities.” The official 2012 NAICS Manual is available in print and on CD-ROM from the National Technical Information Service (NTIS) at (800) 553-6847, or through the NTIS Web site at http://www.ntis.gov.

In general, Federal agencies are prohibited from accepting uncompensated volunteer service. (See 31 U.S.C. 1342, Limitation on Voluntary Services ). However, some statutes authorize Federal agencies to accept voluntary services during emergencies involving the protection of human life or property (31 U.S.C. 1342); voluntary services to assist disabled Federal employees in performing duties (5 U.S.C. 3102); voluntary services by experts and consultants; and voluntary services by students to further their education (5 U.S.C. 3111). In addition, some Federal agencies, such as the National Park Service and the Forest Service, have specific authorization to accept unpaid services for specific jobs or functions. See Volunteers in the Parks Act of 1969, 16 U.S.C. 18g-18i, and Volunteers in the National Forest Program, 16 U.S.C. 558(a).

OSHA has long considered uncompensated volunteers conducting work for Federal agencies to be covered by the Federal safety and health program. The 1980 final rule which established the basic program elements in 29 CFR 1960.2(g) provides: “The term `employee' as used in this part means any person, other than members of the Armed Forces, employed or otherwise suffered, permitted, or required to work by an `agency.' ” The preamble to the final rule states that OSHA purposefully used a broad definition of employee so that individuals like volunteers would be protected under Federal agency safety and health programs. The preamble also states that occupational safety and health programs are designed to address hazardous working conditions and that when individuals, such as volunteers, are conducting work activities similar to those performed by other paid employees, they should receive all the protections of the Federal safety and health program. The definition of “employee” established in the 1980 final rule remains in the current basic program elements for Federal agency safety and health programs set forth at 29 CFR 1960.2(g).

The original injury and illness recordkeeping system for the Federal sector required civilian Executive Branch agencies to record occupational injury and illness information only when such information was also reported to the Office of Workers' Compensation Programs (OWCP). As such, occupational injuries and illnesses were recordable only if a medical expense was incurred or expected, or if the employee was away from work or on leave without pay (LWOP) or continuation of pay (COP) as a result of the injury or illness. Because the Federal Employees' Compensation Act (FECA) as amended (5 U.S.C. 1801 et seq. ) generally covers uncompensated volunteers, occupational injury and illness information for volunteers was recorded by Federal agencies under the original FECA-based recordkeeping system in Part 1960.

Since publication of the revised Federal sector recordkeeping final rule in November 2004, there has been some uncertainty as to whether Federal agencies should record occupational injury and illness information for volunteer workers. While OSHA has consistently considered volunteers to be within the definition of employee for purposes of 29 CFR Part 1960, the preamble to the private sector Part 1904 recordkeeping final rule issued in 2001 essentially states that unpaid volunteers in the private sector are not covered. In 2004, when OSHA adopted most of the provisions from the Part 1904 system to the Federal sector, the Agency did not intend to exclude individuals performing voluntary services for Federal agencies from the Part 1960, Subpart I, recordkeeping system. As a result, OSHA wishes to make clear that the injuries and illnesses of volunteers conducting work activities for Federal agencies, including both unpaid workers and those individuals receiving minimal compensation for services provided, be recorded under the revised Federal sector recordkeeping system.

A number of Federal agencies use large numbers of both full and part-time volunteers to perform various work activities. For example, in Fiscal Year 2009, approximately 173,000 volunteers conducted 5,700,000 work hours for the National Park Service; 95,248 volunteers conducted 3,014,820 work hours for the Forest Service; and 84,367 volunteers conducted 11,897,208 work hours for the Department of Veterans Affairs. The estimates include unpaid volunteers, as well as those individuals receiving minimal compensation, such as meals or academic credit, for services provided.

In some cases, the work activities conducted by volunteers for Federal agencies are similar to those conducted by full-time paid Federal employees. Volunteers may also be working alongside full-time Federal employees, and may be exposed to the same hazards in the workplace. Depending on the number of volunteers working at a particular Federal establishment, the recording of volunteer injury and illness information may produce a more accurate picture of the effectiveness of the establishment's occupational safety and health program. This is of particular concern to OSHA since occupational injury and illness information is used by safety and health personnel and workers to recognize and eliminate hazards in the workplace.

One reason given as part of OSHA's rationale for amending the Part 1960 recordkeeping requirements in November 2004 was to resolve the incompatibility of data that existed between the private sector and the Federal sector. However, one essential difference still remains between the two recordkeeping systems, specifically as it relates to the treatment of injuries and illnesses to volunteers. As previously discussed, the preamble to the January 2001 private sector Part 1904 recordkeeping final rule essentially states that the injuries and illnesses of unpaid volunteers should not be recorded. In the Federal sector, uncompensated volunteers are considered employees and, therefore, subject to the Part 1904 recordkeeping requirements. In order to allow for valid comparisons of injury and illness data between the private and Federal sectors, it is necessary to be able to segregate the recordable injuries to volunteers in the Federal sector from those to paid Federal civilian workers and contractors who are supervised on a day-to-day basis by Federal agency personnel. Section 1960.73(b) of today's final rule requires that Federal agencies designate a “V” in front of the OPM job title series number when recording the injuries and illnesses of uncompensated volunteers on the OSHA Form 300 or equivalent. (See the discussion below regarding entry of the OPM job series number in Column (c) of the OSHA log). Agencies should use the OPM job series number that most closely relates to the type of work being performed by the volunteer at the time of injury or illness. Section 1960.73(c) of today's final rule also requires that Federal agencies with recordable injuries and illnesses to volunteers separately track the total number of hours worked by volunteers, and report this information to OSHA with their annual recordkeeping data submissions.

Section 1904.31 requires employers to record the recordable injuries and illnesses of all their employees, whether classified as labor, executive, hourly, salaried, part-time, seasonal, or migrant workers. Employers are also required to record the recordable injuries and illnesses of all employees they supervise on a day-to-day basis, even if these workers are not carried on the employer's payroll. Day-to-day supervision generally exists when the employer “supervises not only the output, product, or result to be accomplished by the person's work, but also the details, means, methods and processes by which the work objective is accomplished.” (See OSHA's January 15, 2004 letter of interpretation to Leann M. Johnson-Koch: http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=INTERPRETATIONS&p_id=24735 ).

The requirements in § 1904.31 assign the responsibility for recording and reporting to the employer with the greatest amount of control over the working conditions that led to the injury or illness. OSHA stated in the 2001 preamble to the final rule revising the Part 1904 regulation that the supervising employer is in the best position to obtain the necessary injury and illness information due to its control over the worksite and its familiarity with the work tasks and the work environment. The employer with day-to-day supervision is also in the best position to use the injury and illness data to learn about and correct hazards in the workplace.

For the Federal sector, the requirements in § 1904.31 mean that Federal agencies are responsible for recording not only the recordable injuries and illnesses of their own Federal employees, but also are responsible for recording the recordable injuries and illnesses of all workers they supervise on a day-to-day basis.

Federal agencies often use outside contractors to provide goods and services, or employ temporary workers from private sector temporary or leasing agencies. For purposes of recording the injuries and illnesses of private sector workers, the key question for Federal agencies is whether they supervise such workers on a day-to-day basis. When making determinations as to whether to record the injuries and illnesses of private sector workers, Federal agencies must use the criteria set forth in § 1904.31 concerning day-to-day supervision. Of course, if a private contractor or temporary agency is conducting work at a Federal establishment, and provides day-to-day supervision for its employees, the contractor or temporary agency, not the Federal agency, would be responsible for recording injuries and illnesses.

Federal agencies are also responsible for recording the recordable injuries and illnesses of employees from other Federal agencies they supervise on a day-to-day basis. For example, if a Federal employee from the Department of Commerce is detailed to a Department of Transportation (DOT) establishment, the DOT establishment would be responsible for recording any recordable injury or illness if the detailed employee is supervised by DOT personnel on a day-to-day basis. On the other hand, if for example, a Federal employee from the Department of Interior is working at a Department of Treasury establishment, but is still being supervised on a day-to-day basis by his or her home office, the Department of Interior would be responsible for recording injuries and illnesses to their employee.

Because the basic program elements in Part 1960 apply to all Federal establishments worldwide, Federal establishments located in foreign countries are responsible for recording the injuries and illnesses (and calculating the total number of hours worked) of all workers they supervise on a day-to-day basis, even if such individuals are foreign nationals. As with other workers not generally considered “employees” for other purposes, the recording by overseas Federal establishments of injuries and illnesses sustained by foreign nationals they supervise on a day-to-day basis will provide useful information to Federal agencies in their efforts to ensure a safe and healthy workplace for all workers.

In the private sector, § 1904.30(b)(4) addresses the issue of employees who report to one establishment but are injured or made ill at other locations of the same company. Under such circumstances, employers must record cases on the log at the location where the employee became injured or ill. In OSHA's view, in the majority of cases, the place where the injury or illness occurred is the most useful recording location. The events or exposures that caused the case are most likely to be present at that location, so the data are useful for analysis in that location's records. If the case is recorded at the employee's home establishment, the injury or illness data have been disconnected from the place where the case occurred and, therefore, are less likely to be used to identify and correct any hazard. Of course, if an employee is working under the day-to-day supervision of his or her own employer, and the injury or illness occurred at another employer's establishment, or while the employee was in transit, the case would be recorded on the log of the employee's home establishment.

For purposes of Section 1904.30, the Department or Bureau is considered the employer of a Federal employee. As such, the Federal establishment where the injury or illness took place is responsible for recording the case on its log when the incident involves a Federal employee from the same Department or Bureau. For example, if an employee from the Department of Labor's OSHA is conducting a safety and health inspection at a Department of Labor Mine Safety and Health Administration (MSHA) establishment, and sustains an injury or illness, the case would be recorded on the log of the MSHA establishment. Under 1904.30(b)(4), even though the OSHA employee is under the day-to-day supervision of his or her own OSHA establishment, because the employee was injured or made ill at an establishment operated by the same employer, the injury or illness would be recorded on the MSHA log.

As noted elsewhere in today's preamble, Federal agencies are required to record each recordable injury and illness on the OSHA 300 Log or equivalent. Column (c) of the OSHA 300 Log asks for the “job title” of the injured or ill employee.

When filling out the OSHA 300 Log or equivalent, § 1960.73(a) requires Federal agencies to enter all four digits of the employee's job series number in Column (c). For example, agencies should enter “4607 Carpenter” or “0334 Computer Specialist.” Recording the job series number on the OSHA 300 Form will help identify occupations across the Federal sector that are experiencing higher injury and illness rates, and allow Federal agencies and OSHA to focus safety and health training on these occupations. When entering the information in Column (c) for private sector contractors they supervise on a daily basis, Federal agencies should enter the four digit job series number that best reflects the tasks undertaken by that employee.

Section 1904.32(a) of OSHA's private sector recordkeeping regulation requires employers to review their OSHA 300 Log for completeness and accuracy, and prepare an Annual Summary of the OSHA 300 Log using the OSHA Form 300-A, or an equivalent form. The summary must be certified for accuracy and completeness and posted in the workplace by February 1 of the year following the year covered by the summary. Section 1904.32(b)(3) provides that a company executive must certify that he or she examined the OSHA 300 Log and that he or she reasonably believes, based on his or her knowledge of the process by which the information was recorded, that the annual summary is correct and complete.

For Federal agencies, the basic program element at § 1960.67 provides that the person who performs the certification shall be one of the following: (1) The senior management establishment official; (2) the head of the agency for which the senior management official works; or (3) any management official who is in the direct chain of command between the senior establishment management official and the head of the Agency. The note following the basic program element at 1960.67 makes clear that the requirement for certification of Federal agency injury and illness records is necessary because the private sector position titles in 29 CFR part 1904 do not correspond with Federal agency position titles for agency executives. In the preamble to the 2004 final rule revising the Federal agency recordkeeping system, OSHA stated that the certifying official is responsible for ensuring that systems and processes are in place, and for holding the recordkeeper accountable, (See 69 FR 68797). This official must certify that he or she has examined the document and reasonably believes, based on his or her knowledge of the process by which the information was recorded, that the annual summary is accurate and complete.

Since 2004, some Federal agencies have had questions about which official is responsible for certifying the Annual Summary. Under the basic program element at 1960.67, the senior management official at the Federal establishment, such as an Area Office Director, would have the authority to certify the summary. Also, the head of the Federal agency, such as the Assistant Secretary or Under Secretary, can certify the summary. Finally, any management official, such as a Regional Administrator, who is in the direct chain of command between the senior establishment official and the head of the Agency, can certify the summary.

It is important to note that while Federal agencies have several options concerning which official can certify the Annual Summary, the individual must still reasonably believe, based on his or her knowledge of the process by which the information in the Log was reported and recorded, that the Log and Summary are “true” and “complete.” Having a reasonable belief that the records are complete and accurate would suggest, at a minimum, that the certifying official is familiar with OSHA's recordkeeping requirements, and the Federal agency's recordkeeping practices and policies, has read the Log and Summary, and has obtained assurance from the staff responsible for maintaining the records that all of OSHA's requirements have been met and all practices and policies followed. In most cases, the certifying official will be familiar with the details of some of the injuries and illnesses that have occurred at the establishment and will, therefore, be able to spot check the 300 Log to see if those cases have been entered correctly.

Section 19(a)(5) of the OSH Act and Section 1-201(l) of Executive Order 12196 require all Federal agencies to submit to the Secretary of Labor an annual report on their agency's occupational safety and health program. The existing basic program element at § 1960.71(a) requires each Federal agency to submit their report by January 1 of each year, and include a description of the agency's occupational safety and health program for the previous fiscal year, objectives for the current fiscal year, and a summary of the agency's self-evaluation of the effectiveness of their safety and health program. The basic program element also states that the Secretary provide the agencies with the guidelines and format for the reports.

Section 1960.71(b) provides that the Secretary must submit to the President an annual summary report on the status of Federal employee occupational safety and health. The report to the President, which is developed by OSHA's Office of Federal Agency Programs, is partially based on the information submitted by Federal agencies in their annual reports. The basic program element also requires the Secretary to submit the annual report to the President by October 1 of each year.

When OSHA revised the Federal agency occupational injury and illness recordkeeping requirements in November 2004, it established a system based on the private sector requirements in Part 1904, which requires the recording of injuries and illnesses and the maintenance of records on a calendar year basis. Accordingly, in order for Federal agencies to evaluate and submit injury and illness data from the entire calendar year, it is necessary to revise the date when Federal agencies must submit their annual report.

Today's final rule amends the basic program element at 29 CFR 1960.71(a)(1), by revising the date when Federal agencies must submit their annual report to the Secretary from January 1 to May 1. This change is consistent with the timeline established for maintaining records in the Part 1904 recordkeeping system, and will allow Federal agencies to incorporate calendar year injury and illness information into their annual reports. Today's final rule also amends the basic program element at 29 CFR 1960.71(b) which establishes the date by which OSHA must submit the Secretary of Labor's Report to the President on Federal Department and Agency Safety and Health Program Activity. Section 1960.71(b) is amended to require this report be submitted to the President by January 1, or three months later than the previous due date of October 1, while relying on fiscal year data.

The November 2004 final rule revising the reporting and recording requirements for Federal agencies incorporated most of the provisions from the OSHA private sector recordkeeping regulation at 29 CFR Part 1904. The basic program element at § 1960.66(b) provides: “Except as modified by this subpart, Federal agency injury and illness recording and reporting requirements will be the same as 29 CFR Part 1904 subparts C, D, E, and G”.

OSHA did not incorporate Subpart A, Purpose, from the Part 1904 regulation because the basic program element at 29 CFR 1960.66(a). already includes a “Purpose, scope, and general provisions” section applicable to Federal agency recordkeeping. Also, Subpart B, Scope, to Part 1904, which includes Section 1904.1, partial exemption for employees with fewer than 10 employees; § 1904.2, partial exemption for establishments in certain industries; and § 1904.3, keeping records for more than one agency, is not applicable to Federal agency recordkeeping. Accordingly, the recordkeeping requirements for Federal agencies set forth at 29 CFR part 1960, Subpart I, are applicable to all Federal establishments, including those that employ fewer than ten employees, and those which conduct work activities considered to be in a partially exempt industry.

The basic program element at 29 CFR 1960.2(b) provides, in part, that the term “agency” means: “an Executive Department, as defined in 5 U.S.C. 101 or any employing unit or authority of the Executive Branch of the Government.” Section 1960.2(b) also states that the term “agency” includes the United States Postal Service (USPS).

In 1998, the Postal Employee Safety Enhancement Act, Public Law 105-241, made the OSH Act applicable to USPS. Under this legislation, the OSH Act applies to USPS in the same manner as to a private sector employer. For purposes of Section 19 of the OSH Act, Executive Order 12196 and the Basic Program Elements at 29 CFR Part 1960, the definition of “agency” does not include USPS. This means that USPS is subject to enforcement and penalty provisions of the OSHA Act similar to private employers. Today's final rule revises the basic program element at 29 CFR 1960.2(b) to make clear that the definition of “agency” does not include USPS.

Under the OSH Act, OSHA inspects workplaces to determine whether employers are complying with OSHA standards and other statutory and regulatory requirements. In addition, OSHA inspections are conducted to ensure that the hazards are abated. The citation references the alleged violation, notes the proposed penalty, and indicates the date by which the violation is to be abated. Abatement means action by an employer to comply with a cited standard or regulation or to eliminate a recognized hazard identified by OSHA during an inspection.

Employers are required to verify in writing that they have abated cited conditions, in accordance with 29 CFR 1903.19. Section 1903.19(a) provides that the scope of the regulation applies to “employers” who receive a citation for a violation of the OSH Act.

The Federal agency equivalent of a “citation” is the Notice of Unsafe or Unhealthful Working Conditions (OSHA Notice). The basic program element at § 1960.30 addresses the abatement of unsafe or unhealthful working conditions. Among other things, the basic program element provides that when an OSHA Notice is issued, abatement must be within the time set forth in the Notice, or in accordance with an established abatement plan.

The basic program elements do not include procedures for abatement verification when a Federal agency receives an OSHA Notice. In the past, OSHA's written policy has been for Federal agencies to follow the abatement verification procedures for the private sector, (See OSHA Instruction CPL 02-00-150- Field Operations Manual, Chapter 13, Federal Agency Field Activities ). Today's final rule clarifies that the abatement verification procedures in 29 CFR 1903.19 are generally applicable to Federal agencies.

OSHA notes that several of the provisions in § 1903.19 make reference to abatement verification procedures that are only applicable to private sector employers. For example, § 1903.19(b)(2)(ii), addresses abatement dates for contested citation items for which the Occupational Safety and Health Review Commission (Commission), has issued a final order affirming a violation. Because Federal agencies do not receive citations, and are not able to contest OSHA Notices before the Commission, § 1903.19(b)(2)(ii) would not be applicable to Federal agencies.

Other provisions in § 1903.19 are general and address the procedures used by OSHA to ensure abatement. Specifically, paragraphs (c) through (i) in § 1903.19 include private sector abatement verification provisions that are applicable to Federal agencies. When evaluating the procedures in paragraphs (c) through (i), Federal agencies should substitute the word “employer” with “Federal agency,” and “citation” with “OSHA Notice.”

Today's final rule amends the basic program element at 29 CFR 1960.30 by adding paragraph (f) and makes clear that the abatement verification procedures in § 1903.19 are generally applicable to Federal agencies.

In the November 26, 2004 final rule revising Federal agency occupational injury and illness recordkeeping requirements, OSHA inadvertently deleted § 1960.66(f). This section provided that retention and access to employee records must be in accordance with OSHA's regulation at 29 CFR 1910.1020, Access to employee exposure and medical records. Today's final rule reestablishes the former basic program element at 29 CFR 1960.66(f). The revised basic program element states: “Retention and access of employee exposure and medical records shall be in accordance with 29 CFR 1910.1020.”

Section 1960.7(a) requires the head of each Federal agency to ensure that the agency budget submission includes appropriate financial and other resources to effectively implement and administer the agency's occupational safety and health program. Section 1960.7(b), provides that the Designated Safety and Health Official, management officials in charge of each establishment, safety and health officials at all appropriate levels, and other management officials are responsible for planning, requesting resources, implementing, and evaluating the occupational safety and health program budget in accordance with the regulations of the Office of Management and Budget Circular A-11 (sections 13.2(f) and 13.5(f)), and other relevant documents.

The two sections referenced in 29 CFR 1960.7(b) are from the 1981 version of OMB Circular A-11. Section 13.2(f) states: “Agencies will assure that estimates reflect full consideration of the administration's goals and responsibilities to provide safe and healthful work places for Federal employees in accordance with the provisions of Executive Order No. 12196 and the related Safety and Health Provisions for Federal Employees of the Secretary of Labor, (CFR Title 29, Chapter XVII, Part 1960).”

Section 13.5(f) states: “Estimates for the design and construction of Federal facilities and buildings, and for the purchase of equipment, will include amounts required to insure safe and healthful workplaces for Federal employees consistent with the standards promulgated under section 19 of the Occupational Safety and Health Act of 1970. Agencies will assure that estimates for capital improvement will reflect full consideration of the expense of insuring that existing facilities provide safe and healthful places and conditions of employment consistent with these standards.”

Over the years, OMB Circular A-11 has been revised several times. The revisions have resulted in the deletion of Section 13.5(f) and the transfer of some language from Section 13.2(f) to Section 33.1. In order to reduce confusion, and with the realization that the Circular may be revised in the future, OSHA has decided to delete the reference to OMB Circular A-11 in 29 CFR 1960.7(b). OSHA believes that Federal agencies should review and comply with all relevant OMB regulations and documents when evaluating their occupational safety and health budget.

The Federal Advisory Council on Occupational Safety and Health (FACOSH) was established by Executive Order 11612 to advise the Secretary of Labor on matters relating to the occupational safety and health of Federal employees.

During its March 11, 2007 meeting, FACOSH voted to establish a subcommittee to determine how best to collect Federal employee injury and illness recordkeeping information. The subcommittee held three meetings on May 31, June 14, and July 31, 2007, to discuss proposed changes to the Federal agency recordkeeping requirements in 29 CFR Part 1960, Subpart I.

The subcommittee was comprised of six voting members, with equal representation from management and labor. The six voting members included representatives from the Department of Defense, Department of Homeland Security, National Aeronautics and Space Administration, Seafarers International Union, American Federation of Government Employees, and American Postal Service Union. In addition, there were several representatives from various Federal agencies who actively participated in the meeting discussions, and offered special technical expertise and perspective, including representatives from the Department of Labor (including BLS), Transportation Safety Administration, NIOSH, and the Smithsonian Institution.

Participants at the subcommittee meetings supported OSHA's collection of injury and illness records from Federal agencies; encouraged OSHA to develop a variety of options for collecting the data; and recommended that OSHA provide a mechanism for agencies to analyze their injury and illness data. The subcommittee also encouraged OSHA to publicize their intentions and to assist agencies who could not currently aggregate their own data. The subcommittee recommendations were presented to the full Council during an October 11, 2007 FACOSH meeting.

OSHA responded to the FACOSH recommendations by writing to Federal agencies, advising them of the database project, and soliciting a list of Federal agency establishments. OSHA has developed three options for agencies to submit their injury and illness data, with one option offering real-time data entry and analysis capability.

This rule relates to matters of Federal agency management and personnel and, therefore, is exempt from the usual Administrative Procedure Act requirements for prior notice and comment and a 30-day delay in effective date, (See 5 U.S.C. 553(a)(2) and (d)).

The Paperwork Reduction Act (44 U.S.C. 3501 et seq. ) does not apply because this rulemaking, which applies only to Federal agencies, does not create or modify information collection requirements that require the approval of the Office of Management and Budget. Additionally, the Department of Labor has determined that this rulemaking is a nonmajor rule under the Congressional Review Act (5 U.S.C. Chapter 8), and will submit a report thereon to the U.S. Senate, House of Representatives, and General Accounting Office in accordance with that law at the same time this rulemaking document is sent to the Office of the Federal Register for publication.

Because this rulemaking applies only to Federal agencies, the Department of Labor certifies pursuant to the Regulatory Flexibility Act, (5 U.S.C. 605(b)) that this final rule will not have a significant impact on a substantial number of small entities. Similarly, the requirements of the Unfunded Mandates Reform Act of 1995 and Executive Order 13132 addressing “Federalism” do not apply. The Department of Labor has also determined that this is not a “significant regulatory action” under Section 3(f) of Executive Order 12866, “Regulatory Planning and Review,” and that it relates to a matter of agency organization, management, or personnel. See Executive Order 12866; Section 3(d)(3).

As described below.

This document was prepared under the direction of David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor. 200 Constitution Avenue NW., Washington, DC 20210. Accordingly, pursuant to sections 19 and 24 of the Occupational Safety and Health Act of 1970 (84 Stat. 1609, 1614; 29 U.S.C. 668, 673), 5 U.S.C. 553, Secretary of Labor's Order No. 1-2012 (77 FR 3912) and Executive Order 12196, the Department amends 29 CFR part 1960 as set forth below.

For the reasons stated in the preamble, 29 CFR Part 1960 is amended to read as follows:

The North Carolina Department of Transportation, who owns and operates this bascule bridge, has requested a temporary deviation from the current operating regulations set out in 33 CFR 117.821 (a)(4), to facilitate electrical system and mechanical equipment upgrades to the bridge.

Under the regular operating schedule, the draw for the S.R. 74 Bridge, at mile 283.1 over the AICW, at Wrightsville Beach, NC shall open on signal for commercial vessels at all times and on signal for pleasure vessels except between 7 a.m. and 7 p.m., need only open on the hour; and except for annual triathlon events that occur from September through November. The S.R. 74 Bridge has a temporary vertical clearance in the closed position of 18 feet above mean high water due to additional ongoing maintenance.

Under this temporary deviation, the drawbridge will be maintained in the closed to navigation position, beginning at 7 p.m., on Monday, August 19, 2013 until 7 p.m., on Tuesday August 20, 2013. In the event of inclement weather, the alternate dates and times will begin at 7 p.m., on Monday August 26, 2013 ending at 7 p.m., on Tuesday August 27, 2013. The bridge will operate under its normal operating schedule at all other times. The Coast Guard has carefully coordinated the restrictions with commercial and recreational waterway users.

Vessels able to pass under the bridge in the closed position may do so at anytime and are advised to proceed with caution. The bridge will be able to open for emergencies but at a slower rate. There is no immediate alternate route for vessels transiting this section of the AICW but vessels may pass before and after the closure each day. The Coast Guard will also inform additional waterway users through our Local and Broadcast Notices to Mariners of the closure periods for the bridge so that vessels can arrange their transits to minimize any impacts caused by the temporary deviation.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.

Regional Office Contacts:

Region I—Donald Dahl (617) 918-1657,

Region II—Kenneth Fradkin (212) 637-3702,

Region III—Ruth Knapp (215) 814-2191,

Region IV—Lynorae Benjamin (404) 562-9040,

Region V—John Summerhays (312) 886-6067,

Region VI—Dayana Medina (214) 665-7241,

Region VII—Larry Gonzalez (913) 551-7041,

Region VIII—Crystal Ostigaard (303) 312-6602,

Region IX—John Kelly (415) 947-4151, and

Region X—Steve Body (206) 553-0782.

The public may inspect the rule and state-specific technical support information at the following locations:

The following is an outline of the Preamble.

EPA Region 6 is publishing this direct final Notice of Deletion of the Imperial Refining Co. Superfund Site (Site), from the National Priorities List (NPL). The NPL constitutes Appendix B of 40 CFR part 300 which is the Oil and Hazardous Substances Pollution Contingency Plan (NCP), which EPA promulgated pursuant to Section 105 of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) of 1980, as amended. EPA maintains the NPL as the list of sites that appear to present a significant risk to public health, welfare, or the environment. Sites on the NPL may be the subject of remedial actions financed by the Hazardous Substance Superfund (Fund). As described in 300.425(e)(3) of the NCP, sites deleted from the NPL remains eligible for Fund-financed remedial action if future conditions warrant such actions.

Because EPA considers this action to be noncontroversial and routine, this action will be effective September 19, 2013 unless EPA receives adverse comments by September 4, 2013. Along with this direct final Notice of Deletion, EPA is co-publishing a Notice of Intent for Deletion in the “Proposed Rules” section of the Federal Register . If adverse comments are received within the 30-day public comment period on this deletion action, EPA will publish a timely withdrawal of this direct final Notice of Deletion before the effective date of the deletion and the deletion will not take effect. EPA will, as appropriate, prepare a response to comments and continue with the deletion process on the basis of the Notice of Intent for Deletion and the comments already received. There will be no additional opportunity to comment.

Section II of this document explains the criteria for deleting sites from the NPL. Section III discusses procedures that EPA is using for this action. Section IV discusses the Imperial Refining Co. Superfund Site and demonstrates how it meets the deletion criteria. Section V discusses EPA's action to delete the Site from the NPL unless adverse comments are received during the public comment period.

The NCP establishes the criteria that EPA uses to delete sites from the NPL. In accordance with 40 CFR 300.425(e), sites may be deleted from the NPL where no further response is appropriate. In making such a determination pursuant to 40 CFR 300.425(e), EPA will consider, in consultation with the State, whether any of the following criteria have been met:

i. responsible parties or other persons have implemented all appropriate response actions required;

ii. all appropriate Fund-financed response under CERCLA has been implemented, and no further response action by responsible parties is appropriate; or

iii. the remedial investigation has shown that the release poses no significant threat to public health or the environment and, therefore, the taking of remedial measures is not appropriate.

Pursuant to CERCLA section 121(c) and the NCP, EPA conducts five-year reviews to ensure the continued protectiveness of remedial actions where hazardous substances, pollutants, or contaminants remain at a site above levels that allow for unlimited use and unrestricted exposure. EPA conducts such five-year reviews even if a site is deleted from the NPL. EPA may initiate further action to ensure continued protectiveness at a deleted site if new information becomes available that indicates it is appropriate. Whenever there is a significant release from a site deleted from the NPL, the deleted site may be restored to the NPL without application of the hazard ranking system.

The following procedures apply to the deletion of the Site:

(1) EPA has consulted with the state of Oklahoma prior to developing this direct final Notice of Deletion and the Notice of Intent for Deletion co-published in the “Proposed Rules” section of the Federal Register .

(2) EPA has provided the state 30 working days for review of this notice and the parallel Notice of Intent to Delete prior to their publication today, and the state, through the ODEQ, has concurred on this deletion of the Site from the NPL.

(3) Concurrently with the publication of this direct final Notice of Deletion, a notice of the availability of the parallel Notice of Intent for Deletion is being published in a major local newspaper, the Daily Ardmoreite. The newspaper announces the 30-day public comment period concerning the Notice of Intent for Deletion of the Site from the NPL.

(4) The EPA placed copies of documents supporting the deletion in the deletion docket and made these items available for public inspection and copying at the Site information repositories identified above.

(5) If adverse comments are received within the 30-day public comment period on this deletion action, EPA will publish a timely notice of withdrawal of this direct final Notice of Deletion before its effective date and will prepare a response to comments and continue with the deletion process on the basis of the Notice of Intent for Deletion and the comments already received.

Deletion of a site from the NPL does not itself create, alter, or revoke any individual's rights or obligations. Deletion of a site from the NPL does not in any way alter EPA's right to take enforcement actions, as appropriate. The NPL is designed primarily for informational purposes and to assist EPA management. Section 300.425(e)(3) of the NCP states that the deletion of a site from the NPL does not preclude eligibility for further response actions, should future conditions warrant such actions.

The following information provides EPA's rationale for deleting the Site from the NPL.

The Imperial Refining Co. Superfund Site (CERCLIS ID OK0002024099) is the location of a former petroleum refinery that operated from 1917 to 1934 in Ardmore, Carter County, Oklahoma. The numerous tanks and most of the buildings that were present on the Site during the refinery's operation were dismantled between 1934 and 1948, leaving the property as mixed wooded areas and open fields. No records have been found that describe the types of activities that took place on the Site after 1934. Currently, the land is privately owned by the Hogan Family, L.L.C., and no commercial activities are taking place at the Site. The legal description for the property is SE 1/4 , NE 1/4 , Section 20, and SW 1/4 , NW 1/4 , Section 21, T4S, R2E, Indian Meridian, which is located within the northeastern portion of the City of Ardmore, Carter County, Oklahoma (Figure 1). The Site is divided into three parcels: the West (36.5 acres), East (14.5 acres) and East Railroad (21 acres). The Site covers approximately 72 acres and is bisected by U.S. Highway 142 and railroad tracks operated by the BNSF Railway Company. The adjacent property to the north and east of Hwy 142 is occupied by a facility that manufactures roofing shingles. Waste-water processing lagoons operated by Valero Refining are located west of the Site, and the rest of the immediately adjacent property is largely undeveloped.

The Imperial Refining Co. began operations at the Site in 1917. The eastern portion of the property was purchased in April 1917, and the western portion was purchased three months later. Imperial Refining Co. remained active for 17 years until it went bankrupt in 1934. Due to the absence of environmental regulations during the operational period, no permits, violations, inspections, or facility operation documentation have been identified, and no records have been found that describe the types of activities that took place on the Site. The ODEQ conducted a Preliminary Assessment in September 1997 and a Site Inspection (SI) in July 1998. During the SI and Removal Assessment, investigators noted 12 waste piles containing an asphalt-like material scattered throughout the property. Soil, sediment, waste pile, and surface water samples were collected. There were numerous pits, piles, and water impoundments contaminated with metals and polynuclear aromatic hydrocarbons (PAHs).

The waste material was found in 12 distinct piles across the Site, one vertical tank remnant, and one underground storage tank (UST). The average thickness of the waste piles was approximately 1foot (ft), and the benzo(a)pyrene concentrations range from 2.5 milligrams per kilogram (mg/kg) to 570 mg/kg. In addition to the waste material, surface soil (0-1 ft below ground surface) and sediment (0-1 ft below ground surface) had elevated concentrations of benzo(a)pyrene and arsenic. The soil concentrations ranged from 1 mg/kg to 90 mg/kg for arsenic and 0.04 mg/kg to 10.2 mg/kg for benzo(a)pyrene. The exposure routes of concern were direct contact and ingestion. Sediments in onsite intermittent drainages were indistinguishable from Site soils except by their location within drainages; therefore, the drainage sediments were considered soils for the remedial action. The sediment concentrations range from 4.7 mg/kg to 33.4 mg/kg for arsenic and 0.062 mg/kg to 1.3 mg/kg for benzo(a)pyrene.

Based on the results, ODEQ referred the property to the EPA for further action. EPA conducted a Removal Assessment in 1998 to determine the absence/presence of hazardous materials and the types and concentrations and a second Removal Assessment in 1999 to estimate waste pile volumes and evaluate disposal options. Based on these results, the Site was proposed to the NPL on May 11, 2000, ( Federal Register : May 11, 2000 [Volume 65, No. 92, Page 30489-30495]) and was finalized on July 27, 2000 ( Federal Register : July 27, 2000 [Volume 65, Number 145, Page 46096-46104)]). A Removal Action to install a perimeter fence to secure the Site was conducted by EPA from June 29, 2004 through July 23, 2004.

The EPA and ODEQ negotiated a Cooperative Agreement under which the ODEQ was the lead agency for the Remedial Investigation/Feasibility Study (RI/FS) with EPA acting as the supporting agency. From early 2005 through early 2007, contractors for the ODEQ conducted a RI/FS including field sampling and investigation activities of soil, sediment, surface water, ground water, and animal tissue. The RI/FS identified the types, quantities, and locations of contaminants found in these samples and developed ways to address the contamination. A Human Health Risk Assessment and an Ecological Risk Assessment were performed to determine the current and future effects of contaminants on human health and the environment.

On-site contamination included waste material, soil and sediment. Arsenic and benzo(a)pyrene are the primary contaminants of concern. The primary sources of contaminants are waste in an underground storage tank and waste piles characterized as dry, asphalt-like material. The waste material is found throughout the Site, and the benzo(a)pyrene concentrations range from 2.5 mg/kg to 570 mg/kg. In addition to the waste material, surface soil (0-1 ft below ground surface) and sediment (0-1 ft below ground surface) have elevated concentrations of benzo(a)pyrene and arsenic. The soil concentrations range from 1 mg/kg to 90 mg/kg for arsenic and 0.04 mg/kg to 10.2 mg/kg for benzo(a)pyrene. Sediments in on-site intermittent drainages are indistinguishable from Site soils except by their location within drainages; therefore, the drainage sediments are considered soils for the remedial action as these remain dry most of the year.

A proposed plan for the Site was issued in September 2007, presenting the preferred alternative of excavation and offsite disposal for the waste, contaminated soil, and contaminated sediment at the Site. The Record of Decision (ROD) was signed on December 26, 2007. Remedial Action Objectives (RAOs) were developed for Site soil, sediment, and waste material.

• Prevent exposure to current and future human and ecological receptors through ingestion, dermal contact, and inhalation of contaminated soil containing arsenic and benzo(a)pyrene concentrations in excess of 5E-05 and 2.5E-05 excess cancer risk, respectively.

• Prevent exposure to current and future human receptors through ingestion, dermal contact, and inhalation of contaminated sediment containing arsenic concentrations in excess of 5E-05 excess cancer risk.

• Prevent exposure to current and future ecological receptors through direct contact, food chain uptake, and incidental ingestion of contaminated sediment containing benzo(a)pyrene concentrations in excess of levels that are protective of ecological receptors.

• Prevent exposure to human and ecological receptors through ingestion and dermal contact.

• Prevent further migration of waste material contamination. In order to achieve these RAOs, numerical risk-based cleanup levels were established for each environmental medium based on the residential scenario.

The EPA began on-site Remedial Action construction on February 13, 2008. During remedial action, a total of approximately 105,993 cubic yards of waste/soil and sediment were removed from the Site and shipped to an offsite landfill. Excavated areas were backfilled, graded and seeded after confirmation sampling indicated that cleanup levels have been met. As excavation activities progressed, waste was found along the borders of the property, throughout the ponds, and surrounding a high pressure gas line. Excavation and removal of waste along the borders was not feasible, safe or practical due to its proximity to sloped areas supporting the highway, the rail line, and business property, as well as its depth under significant volumes of uncontaminated overburden.

A ROD amendment proposed plan for the Site was issued in November 2008, presenting an additional containment component to the remedy selected in the ROD in areas of the Site where excavation would be impracticable and potentially dangerous to the original excavation and offsite disposal remedy. On February 20, 2009, the EPA Superfund Division Director for Region 6 signed a ROD amendment.

Based on excavation activities and delineation pits throughout the east and west ponds, surface sediment exceeding the ecological cleanup numbers was completely removed. Due to the presence of 18 inches of uncontaminated overburden, the complete removal of surface sediment exceeding the ecological cleanup numbers, and the unknown locations at depth throughout the remaining areas of the ponds, no further excavation occurred in the ponds. Excavation in close proximity to the high pressure gas line was not recommended or considered safe; therefore, waste remains around the gas line within the easement boundaries.

The cleanup levels for the Site were reevaluated in the 2009 ROD Amendment. Because waste remains in-place, cleanup levels for the Site changed from residential to industrial land use. The soil cleanup level for benzo(a)pyrene changed to 5.27 mg/kg. The soil cleanup level is still in line with the latest toxicity toxicological benchmarks. The soil cleanup level for arsenic did not change, and no change was made to sediment cleanup levels. The Site is restricted to industrial use through the enforcement of institutional controls (ICs).

The 2009 ROD Amendment required the placement of a clay barrier over waste material left in place. The materials left in place are identified as non-hazardous waste and all data indicate that the leaching potential of this material is below regulatory limits for characteristic hazardous waste categories and land disposal restrictions. The backfill material is identified as clayey sand and is expected to have a low hydraulic conductivity (within the range of 1 x 10-3 centimeters per second to 1 x 10-5 centimeters per second). As such, backfill of the excavated areas and areas above the waste material eliminates the potential for direct contact, ingestion, and migration as well as provides for slope control, drainage control, and the establishment of vegetation.

All threats at the Site have been addressed through excavation and disposal of contaminated material, isolation and capping of non-hazardous materials, installation of fencing, posting of warning signs, and implementation of institutional controls. Remedial activities included:

• Transportation and disposal (at a permitted off-site waste disposal facility) of approximately 31,621 yd 3 of debris (non-hazardous debris, foundry sand, and slag) and the asbestos-containing material in the on-site building and scattered throughout the Site;

• Removal and disposal of an electrical transformer, and underground storage tank in the vicinity of MW-20 and Lead Area 1, and the management and disposal of foundry bag filters identified as a listed K061 waste material;

• Excavation and treatment (solidification/stabilization, if necessary) of approximately 13,600 yd 3 of soils with lead concentrations equal to or greater than 500 mg/kg to a maximum depth of 1.5 feet bgs and approximately 3,000 yd 3 of soils stockpiled at the Site from a previous removal action, and transportation and disposal (at a permitted off-site wastes disposal facility) of the treated and untreated soils;

• Excavation and disposal (at a permitted off-site waste disposal facility) of approximately 2,100 yd 3 of soils contaminated with benzo(a)pyrene, or other organics, at the MW-11 location, and total petroleum hydrocarbons at the MW-20 location;

• Confirmation sampling for several locations identified to have been impacted by either semi-volatile organic compounds.

The soil remedial action at the Site consisted of the sampling and excavation, including the proper disposal of the soils contaminated with arsenic greater than 20 mg/kg and benzo(a)pyrene greater than 5.27 mg/kg. The soil cleanup levels were based on a residential scenario of 20 mg/kg for arsenic and an industrial scenario of 1.55 mg/kg for benzo(a)pyrene specified in Record of Decision Amendment. The sediment remedial action at the Site consisted of the sampling and excavation, including the proper disposal of the sediments contaminated with arsenic greater than 20 mg/kg and benzo(a)pyrene greater than 0.782 mg/kg. The sediment cleanup levels were based on a residential scenario of 20 mg/kg for arsenic and an ecological scenario of 0.782 mg/kg for benzo(a)pyrene specified in the Record of Decision. Institutional controls were required for the soils since the soils were cleaned up to an industrial level which did not exceed the cleanup level below 1.5 feet below ground surface. A total of 107,299 tons, approximately 105, 993 cubic yards, of material were sent to the Waste Connection Landfill in Alex, Oklahoma.

The EPA reviewed the remedial action contract and the construction work for compliance with quality assurance and quality control (QA/QC) protocols. Construction activities at the Site were determined to be consistent with the ROD and adhered to the approved quality assurance plan which incorporated all EPA and State requirements. Confirmatory inspections, independent testing, audits, and evaluations of materials and workmanship were performed in accordance with the technical specifications and plans. The EPA Remedial Project Manager and State regulators visited the site during construction activities to review construction progress and evaluate and review the results of QA/QC activities. No deviations or non-adherence to QA/QC protocols, or specifications were identified.

The quality assurance project plan incorporated all EPA and State QA/QC procedures and protocols. All monitoring equipment was calibrated and operated in accordance with the manufacturer's instructions. The EPA analytical methods were used for all confirmation and monitoring samples during RA activities. Contract laboratory program-like procedures and protocol were followed for soil, sediments, and water analyses during the RA using a private laboratory.

The EPA contract for the remedial action contained provisions for performing sampling during all remedial activities in order to verify that remedial objectives were met, to ensure quality control and assurance for all excavation and construction activity, and to ensure protection and safety of the public, the environment, and the onsite worker. Sampling was conducted in accordance with the Site Field Sampling Plan and all analytical results are below the established cleanup levels for an industrial reuse scenario. In addition, all backfill confirmation sample results met the established cleanup levels for an industrial reuse scenario. All analytical data was independently validated, and the EPA determined that analytical results were accurate to the degree needed to assure satisfactory execution of the RA.

An Operation and Maintenance (O&M) plan for the Site is in effect and is required because waste has been left in place and the Site has been restricted to industrial use. ODEQ is responsible for conducting O&M activities on annual basis or more frequently if necessary. O&M activities include Site inspections for erosion, property uses, and enforcement of the Institutional Controls (ICs). This activity may also include maintenance of the slopes through grading, seeding, or importing of backfill that may be needed. Maintenance of these slopes will provide continued slope support, continued drainage control, and continued vegetation growth. Areas of primary interest will include the slopes along Hwy 142, Atlas Roofing Inc., Oneok Gas Pipeline, BNSF Railway, and Valero Refining. Site operational and functional activities were conducted by EPA until ODEQ took over O&M of the Site in December 2012.

All administrative tools have been implemented at the Imperial Refining Superfund Site. Seven deed notices/covenants identifying restrictions were filed with the Carter County Clerk from June 2009 to August 2011. Appendix N of the Final Remedial Action Report contains copies of each deed notice/covenant.

Some of the deed restrictions include the following requirements and information:

• No residential land use,

• No digging below 5 feet where waste remains in place,

• No activities that will disturb or cause erosion of the sediments within the ponds located on the site,

• No excavations causing erosion,

• No excavation below base material of the road bed (State Highway 142)

Roadway and right-of-way, and

• No ground water taken or well drilling allowed.

Five-Year Reviews of the Site are statutorily required because hazardous substances, pollutants, or contaminants remain at the Site above levels that allow for unlimited use and unrestricted exposure. The first five-year review was conducted at the Site in February 2013. The implemented action taken at the Imperial Refining Superfund Site was found to be protective of human health and the environment in the long-term. The Imperial Refining Co. Superfund Site's first Five-Year Review Report protectiveness determination follows:

The next Five-Year Review will be performed in 2018.

Public participation activities have been satisfied as required in CERCLA Section 113(k), 42 U.S.C. 9613(k) and CERCLA Section 117, 42 U.S.C. 9617. Throughout the Site's history, the community has been interested and involved with Site activity. The EPA has kept the community and other interested parties updated on Site activities through informational meetings, fact sheets, and public meetings. Documents in the deletion docket which the EPA relied on for recommendation for the deletion from the NPL are available to the public in the information repositories, and a notice of availability of the Notice of Intent for Deletion has been published in the Daily Ardmorite to satisfy public participation procedures required by 40 CFR 300.425(e)(4).

The implemented remedy achieves the degree of cleanup specified in the ROD and ROD Amendment for all pathways of exposure. All selected remedial action objectives and clean-up goals are consistent with agency policy and guidance. No further Superfund responses are needed to protect human health and the environment at the Site.

In accordance with 40 CFR 300.425(e), sites may be deleted from the NPL where no further response is appropriate.

The EPA, with concurrence of the State of Oklahoma, through the ODEQ, has determined that all appropriate response actions under CERCLA have been completed. Therefore, EPA is deleting the Site from the NPL.

Because EPA considers this action to be noncontroversial and routine, EPA is taking it without prior publication. This action will be effective September 19, 2013 unless EPA receives adverse comments by September 4, 2013. If adverse comments are received within the 30-day public comment period, EPA will publish a timely withdrawal of this direct final notice of deletion before the effective date of the deletion and it will not take effect. EPA will prepare a response to comments and continue with the deletion process on the basis of the notice of intent to delete and the comments already received. There will be no additional opportunity to comment.

For the reasons set out in this document, 40 CFR Part 300 is amended as follows:

The NPDB was established by Title IV of Public Law 99-660, the Health Care Quality Improvement Act of 1986, as amended. The NPDB is primarily an alert or flagging system intended to facilitate a comprehensive review of health care practitioners' professional credentials. Section 1128E of the Social Security Act, added by the Health Insurance Portability and Accountability Act (HIPAA) of 1996, (Pub. L. 104-191), created the Health Care Integrity and Protection Data Bank (HIPDB). Because a major component of the HIPAA's purpose was to establish a health care fraud and abuse control program, the legislation required the creation of a national data bank to receive and disclose certain adverse actions against health care practitioners, providers, and suppliers, thus establishing the HIPDB. Together the HIPDB and NPDB served to facilitate the review of health care practitioners' and entities' backgrounds, however, some of the information collected under the HIPDB is also available under the NPDB.

In recognition of the overlapping purposes of the laws governing the two data banks, and to eliminate the duplicative information in both data banks, Section 6403 of the Affordable Care Act required the Secretary for the Department of Health and Human Services (HHS) to merge the data banks so that information previously collected and disclosed under the Section 1128E authority be transferred and made available under the NPDB. In addition, Section 6403 ceases HIPDB operations. The Affordable Care Act effectively streamlines data reporting and disclosure through the merge of the data banks and improves program efficiency around reporting and querying. On April 5, 2013, HRSA published a final rule in the Federal Register (78 FR 20473), implementing the merge of the HIPDB information into the NPDB. The rule became effective on May 6, 2013. All security standards remain in place to protect the confidentiality of the NPDB. Section 1128E information now reported under the NPDB is still only available to those entities authorized to query it.

Because the statute permits the information collected in the NPDB and HIPDB to be used by federal and state government agencies with the responsibility of investigating and prosecuting violations of civil and criminal laws, the NPDB and HIPDB were made exempt from certain portions of the Privacy Act under two separate provisions, 45 CFR 5b.11(b)(2)(ii)(F) and (L). As cross referenced in this section, the access and correction rights of individuals are detailed in the regulations governing the NPDB and HIPDB.

This final rule revises the cross reference found in the Privacy Act regulations at 45 CFR 5b.11(b)(2)(ii)(L) from § 60.16 to § 60.21, to reflect the changes made to the NPDB regulation required by the Affordable Care Act.

The system of records notice for the NPDB, which was last published in the Federal Register on March 30, 2012, (77 FR 19295), is being republished elsewhere in this issue of the Federal Register to reflect this change.

HHS ordinarily publishes a notice of proposed rulemaking in the Federal Register to provide a period for public comment before the provisions of a rule take effect, in accordance with Section 553(b) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). However, this notice and comment procedure can be waived if the Secretary finds, for good cause, that the notice and comment process is impracticable, unnecessary, or contrary to the public interest, and incorporates a statement of the finding and the reasons therefore in the notice.

Section 553(d) of the APA ordinarily requires a 30-day delay in effective date of final rules after the date of their publication in the Federal Register . This 30-day delay in effective date can be waived, however, if an agency finds there is good cause to do so, and the agency incorporates a statement of the findings and its reasons in the rule issued.

This document is purely technical in nature and merely corrects a cross-reference in the Privacy Act regulations at 45 CFR 5b.11(b)(2)(ii)(L), from § 60.16 to § 60.21. The change is not a substantive change and does not alter any rights or obligations. Therefore, the Secretary believes that undertaking further notice and comment procedures to incorporate this correction, which will delay the effective date for this change, is unnecessary. In addition, the Secretary believes it is important for the public to have the correct information as soon as possible, and further believes it is contrary to the public interest to delay the dissemination of it. For the reasons stated above, the Secretary finds there is good cause to waive notice and comment procedures and the 30-day delay in the effective date for this correction notice.

This final rule is technical in nature and does not increase regulatory burden. In accordance with the provisions of Executive Orders 13563 and 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), the Office of Management and Budget has determined that it will have no major effect on the economy or federal expenditures. This rule is not economically significant under section 3(f) of Executive Order 12866 and is not being treated as a “significant regulatory action” under section 3(f). Accordingly, the rule has not been reviewed by the Office of Management and Budget.

The Secretary has determined that this final rule is not a “major rule” within the meaning of the statute providing for Congressional Review of Agency Rulemaking, 5 U.S.C. 801, and has determined that it does not meet the criteria for a significant regulatory action. In addition, under the Small Business Enforcement Act (SBEA) of 1996, if a rule has a significant economic effect on a substantial number of small businesses, the Secretary must specifically consider the economic effect of a rule on small business entities and analyze regulatory options that could lessen the impact of the rule. The Secretary has reviewed this exemption in accordance with the provisions of the SBEA and certifies that this exemption will not have a significant impact on a substantial number of small entities.

Similarly, it will not have effects on state, local, and tribal governments and on the private sector such as to require consultation under the Unfunded Mandates Reform Act of 1995.

Executive Order 13132 requires agencies to meet certain requirements when a rule has “federal implications,” and may have “substantial direct effects on the states, or on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.” The Secretary has reviewed this final rule in accordance with Executive Order 13132 regarding federalism, and has determined that it does not have substantial federalism implications or direct costs and implications for the state and local governments.

This final rule does not have any information collection requirements.

Amend 45 CFR part 5b as follows:

This document announces that, on July 22, 2013, OMB approved, for a period of three years, certain information collection requirements contained in the Commission's Orders, FCC 11-161, published at 76 FR 73830, November 29, 2011, FCC 12-52, published at 77 FR 30904, May 24, 2012 and FCC 12-137, published at 78 FR 3837, January 17, 2013, and DA 13-332, published at 78 FR 22198, April 15, 2013. The OMB Control Number is 3060-0986. The Commission publishes this notice as an announcement of the effective date of 47 CFR 54.313(a)(7)-(a)(10), and (c)-(h). If you have any comments on the burden estimates listed below, or how the Commission can improve the collections and reduce any burdens caused thereby, please contact Judith B. Herman, Federal Communications Commission, Room 1-C823, 445 12th Street SW., Washington, DC 20554. Please include the OMB Control Number, 3060-0986, in your correspondence. The Commission will also accept your comments via email. Please send them to PRA@fcc.gov .

To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to fcc504@fcc.gov or call the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that it received OMB approval on July 22, 2013, for the information collection requirements contained in the Commission's rules at 47 CFR 54.313(a) through (h).

Under 5 CFR 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number.

No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Number is 3060-0986.

The foregoing notice is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, and 44 U.S.C. 3507.

The total annual reporting burdens and costs for the respondents are as follows:

OMB Control Number: 3060-0986.

OMB Approval Date: July 22, 2013.

OMB Expiration Date: July 31, 2016.

Title: Competitive Carrier Line Count Report and Self-Certification as a Rural Carrier, WC Docket No. 10-90.

Form No.: FCC Forms 525 and 481.

Respondents: Business or other for-profit entities, not-for-profit institutions and state, local or tribal government.

Number of Respondents and Responses: 8,690 respondents; 8,804 responses.

Estimated Time per Response: .5 hours to 100 hours.

Frequency of Response: Annual, on occasion and quarterly reporting requirements, recordkeeping requirement and third party disclosure requirement.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 151, 154(i) and (j), 205, 221(c), 254, 303(r), 403, 410 and 1302 of the Communications Act of 1934, as amended.

Total Annual Burden: 272,017 hours.

Total Annual Cost: N/A.

Nature and Extent of Confidentiality: Parties may submit confidential information in relation to sub-item o in item 12 of the supporting statement pursuant to a protective order. We note that USAC must preserve the confidentiality of all data obtained from respondents and contributors to the universal service program; must not use the data except for the purposes of administering the universal service support program; and must not disclose data in company-specific form unless directed to do so by the Commission.

Needs and Uses: The Commission has received OMB approval for a three year period to the revisions of this information collection. There are no changes to the FCC Form 525, which is part of this information collection. New FCC Form 481 is being added to this information collection. FCC Form 481 will collect information described in the supporting statement from sub-items h-p of item 12. FCC Form 481 will also collect information, already approved under OMB Control Number 3060-0819, that ETCs receiving low-income universal service support must include in their annual reports. The Commission developed FCC Form 481 in order to reduce the burden on ETCs subject to both high-cost and low-income reporting rules and so the information will be collected in a uniform format. For complete details regarding this revision, please see the 60 day notice that was published in the Federal Register on February 25, 2013, 78 FR 12750.

The snapper-grouper fishery of the South Atlantic includes snowy grouper and is managed under the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP). The FMP was prepared by the South Atlantic Fishery Management Council and is implemented under the authority of the Magnuson-Stevens Fishery Conservation and Management Act by regulations at 50 CFR part 622.

The commercial ACL (equivalent to the commercial quota) for snowy grouper in the South Atlantic is 82,900 lb (37,603 kg), gutted weight, for the current fishing year, January 1 through December 31, 2013, as specified in 50 CFR 622.190(a)(1).

Under 50 CFR 622.193(b)(1), NMFS is required to close the commercial sector for snowy grouper when the commercial ACL (commercial quota) is reached, or is projected to be reached, by filing a notification to that effect with the Office of the Federal Register. NMFS has determined that the commercial ACL for South Atlantic snowy grouper will have been reached by August 10, 2013. Accordingly, the commercial sector for South Atlantic snowy grouper is closed effective 12:01 a.m., local time, August 10, 2013, until 12:01 a.m., local time, January 1, 2014.

The operator of a vessel with a valid commercial vessel permit for South Atlantic snapper-grouper having snowy grouper onboard must have landed and bartered, traded, or sold such snowy grouper prior to 12:01 a.m., local time, August 10, 2013. NMFS implemented a closure of the recreational sector for snowy grouper in the South Atlantic on May 31, 2013 (78 FR 30779, May 23, 2013). During the recreational closure, and thus, during this commercial closure, the bag and possession limit for snowy grouper in or from the South Atlantic EEZ is zero. Also during the commercial closure, the sale or purchase of snowy grouper taken from the EEZ is prohibited. The prohibition on sale or purchase does not apply to the sale or purchase of snowy grouper that were harvested, landed ashore, and sold prior to 12:01 a.m., local time, August 10, 2013, and were held in cold storage by a dealer or processor.

For a person on board a vessel for which a Federal commercial or charter vessel/headboat permit for the South Atlantic snapper-grouper fishery has been issued, the bag and possession limit and the sale and purchase provisions of the commercial closure for snowy grouper would apply regardless of whether the fish are harvested in state or Federal waters, as specified in 50 CFR 622.190(c)(1)(ii).

The Regional Administrator, Southeast Region, NMFS, has determined this temporary rule is necessary for the conservation and management of snowy grouper and the South Atlantic snapper-grouper fishery and is consistent with the Magnuson-Stevens Act, the FMP, and other applicable laws.

This action is taken under 50 CFR 622.193(b)(1) and is exempt from review under Executive Order 12866.

These measures are exempt from the procedures of the Regulatory Flexibility Act because the temporary rule is issued without opportunity for prior notice and comment.

This action responds to the best available scientific information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, (AA), finds that the need to immediately implement this action to close the commercial sector for snowy grouper constitutes good cause to waive the requirements to provide prior notice and opportunity for public comment pursuant to the authority set forth in 5 U.S.C. 553(b)(B), as such procedures would be unnecessary and contrary to the public interest. Such procedures would be unnecessary because the rule itself has been subject to notice and comment, and all that remains is to notify the public of the closure.

Allowing prior notice and opportunity for public comment is contrary to the public interest because of the need to immediately implement this action to protect snowy grouper since the capacity of the fishing fleet allows for rapid harvest of the commercial ACL (commercial quota). Prior notice and opportunity for public comment would require time and would potentially result in a harvest well in excess of the established commercial ACL (commercial quota).

For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).