Federal Register Vol. 82, No.209,

DOE published a RFI pertaining to the test procedure for distribution transformers on September 22, 2017. 82 FR 44347. The RFI initiated a data collection process to consider whether to amend DOE's test procedures for distribution transformers. DOE requested written comment, data, and information pertaining to these test procedures by October 23, 2017.

The National Electrical Manufacturers Association (NEMA), an interested party in the matter, requested a two-week extension of the public comment period for the RFI published in the Federal Register on October 5, 2017. (NEMA, No. 4, at p. 1)

DOE believes that re-opening the comment period to allow additional time for interested parties to submit comments is appropriate. Therefore, DOE is re-opening the comment period until November 6, 2017 to provide interested parties additional time to prepare and submit comments. Comments received between the original October 23 closing date and the new November 6 closing date are considered timely filed. Therefore, individuals who submitted late comments during the original comment period do not need to re-submit comments.

The proposed rule would revoke the regulation authorizing the use of a health claim regarding the relationship between soy protein and risk of coronary heart disease (CHD) (§ 101.82 (21 CFR 101.82)). In this proposed rule, we tentatively conclude, based on our reevaluation of the totality of the publicly available scientific evidence now available, that the evidence does not support our previous determination that there is SSA to support an authorized health claim for the relationship between soy protein and reduced risk of CHD.

In 1999, we authorized a health claim about the relationship between soy protein and a reduced risk of CHD (§ 101.82). In the Federal Register of December 21, 2007, we announced our intention to reevaluate the scientific evidence for this health claim and provided the opportunity for public comment (72 FR 72738). We explained that we were reevaluating the scientific basis for the soy protein and CHD health claim because new studies yielded varied and inconsistent findings (beneficial effect, no effect) from one trial to another. The results of these studies called into question the conclusions drawn from our prior review, which had served as the basis for authorizing the soy protein and reduced risk of CHD health claim. This proposed rule is the next step in our reevaluation.

The proposed rule would revoke the soy protein and CHD claim in § 101.82 because it does not meet the SSA standard. Our decision about whether to authorize a health claim represents FDA's determination as to whether there is “significant scientific agreement” among qualified experts that the publicly available scientific evidence supports the substance/disease relationship that is the subject of a proposed health claim. In our reevaluation of the scientific evidence in this proposed rule, we use our approach outlined in the “Evidence-Based Review System for the Scientific Evaluation of Health Claims” (hereinafter the 2009 guidance) to evaluate the totality of publicly available scientific evidence to determine if the SSA standard in section 403(r)(3) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. (343(r)(3)) is met (Ref. 1). Our reevaluation of the totality of the publicly available scientific evidence indicates that, although some evidence suggests a relationship between soy protein intake and reduced risk of CHD, the totality of the evidence is inconsistent and not conclusive. Therefore, we have tentatively determined that the strength of the totality of the publicly available data does not meet the SSA standard for a relationship between soy protein intake and CHD risk.

The costs of this proposed rule, if finalized, are relabeling the estimated 200 to 300 products currently making the health claim. We estimate total annualized costs of $35,000 to $81,000, when the relabeling costs are annualized over 20 years at a 7 percent discount rate. The initial one-time costs are $370,000 to $860,000.

The benefit of this rule is better information for the consumers who are considering purchasing products with soy protein. This may generate an unknown amount of increased consumer surplus. Some consumers may react to this new information by switching their consumption to products that they enjoy more, or products that still have an authorized health claim. By basing their consumption decisions on more recent and accurate scientific information, they may get more consumer surplus, in the form of enjoyment and/or potential health benefits, from the bundle of products they consume.

In the Federal Register of November 10, 1998 (63 FR 62977), and in response to a petition from Protein Technologies International, Inc. (see Docket No. FDA-1998-P-1154), we proposed to provide for health claims on the relationship of soy protein and reduced risk of CHD (hereinafter referred to as the 1998 soy protein proposed rule). In the 1998 soy protein proposed rule, we considered the relevant scientific studies and data presented in the petition as part of our review of the scientific literature on soy protein and CHD. We summarized these studies in table 1 of the soy protein proposed rule (63 FR 62977 at 62998) and presented the rationale for a health claim on this food/disease relationship as provided for under the significant scientific agreement standard in section 403(r)(3)(B)(i) of the FD&C Act and § 101.14(c).

In our 1998 evaluation of the scientific evidence for a relationship between consumption of soy protein and blood total and LDL-cholesterol levels (two validated surrogate endpoints for risk of CHD), we found the data suggestive, but not sufficient, to establish a dose-response for this relationship. However, we found consistent, clinically significant reductions of total- and LDL-cholesterol levels in controlled trials that used at least 25 grams (g) of soy protein per day. Thus, we proposed to base the qualifying level of soy protein on a total daily intake of 25 g, as suggested by the petitioner. For the purposes of health claims, we assumed there are four eating occasions a day (i.e., three main meals and one snack). Therefore, in § 101.82(c)(2)(iii)(A), we proposed the qualifying criterion for a food to bear the claim as 6.25 g of soy protein per reference amount customarily consumed (RACC) (i.e., 25 g divided by four eating occasions per day).

In the Federal Register of October 26, 1999 (64 FR 57700), we authorized a health claim for soy protein and risk of coronary heart disease (21 CFR 101.82). As explained in the final rule, we determined, based on our review of evidence submitted with comments to the proposed rule, as well as evidence described in the proposed rule, that soy protein included in a diet low in saturated fat and cholesterol may reduce the risk of CHD by lowering blood cholesterol levels. FDA's requirements for use of the health claim and model health claim language were codified at 21 CFR 101.82.

FDA evaluates new scientific information that becomes available to determine whether it necessitates a change to an SSA health claim. On December 21, 2007, we published a notice in the Federal Register (72 FR 72738) (the 2007 reevaluation notice) announcing our intent to reevaluate the scientific evidence for certain health claims, including the authorized health claim for soy protein and risk of CHD (§ 101.82). We stated that we were reevaluating the scientific basis for the soy protein and CHD health claim because numerous studies published since we had authorized the health claim had evaluated the relationship between soy protein and CHD, and the findings of these studies were inconsistent from study to study. For example, the Agency for Healthcare Research and Quality (AHRQ) released a report in July 2005 outlining the effects of soy products on health outcomes, including cardiovascular disease, and concluded that soy products appear to exert a small benefit on LDL cholesterol (Ref. 2). However, the AHRQ report included studies that evaluated substances in addition to soy protein (e.g., isolated soy isoflavones). It was not clear from the AHRQ report whether the soy protein, or other components of soy products such as isoflavones, were responsible for lowering LDL cholesterol. In addition, the AHRQ report used markers of cardiac function (e.g., triglycerides, endothelial function, and oxidized low-density lipoprotein) that are not surrogate endpoints recognized by FDA for CHD risk.

Subsequently, we received a citizen petition dated August 8, 2008 (Docket Number FDA-2008-P-0452-001) (hereinafter “the 2008 citizen petition”), requesting that the Commissioner of Food and Drugs revoke § 101.82. On January 4, 2016, we denied the petitioner's request because the limited relevant evidence submitted in the petition and a supplement to the petition did not provide sufficient grounds for us to revoke the soy protein and CHD health claim. However, as noted in the response to the citizen petition, we considered the relevant studies included in the petition as part of our reevaluation.

The Nutrition Labeling and Education Act of 1990 (NLEA) (Pub. L. 101-535) amended the FD&C Act by, among other things, adding section 403(r) to the FD&C Act. This section specifies, in part, that a food is misbranded if it bears a claim that expressly or by implication characterizes the relationship of a nutrient to a disease or health-related condition unless the claim is made in accordance with section 403(r)(3) of the FD&C Act (for conventional foods) or 403(r)(5)(D) of the FD&C Act (for dietary supplements).

The NLEA also directed FDA to issue regulations authorizing health claims (i.e., labeling claims that characterize the relationship of a nutrient to a disease or health-related condition) for conventional foods if we determine, based upon the totality of publicly available scientific evidence (including evidence from well-designed studies conducted in a manner that is consistent with generally recognized scientific procedures and principles), that there is SSA, among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported by such evidence (see section 403(r)(3)(B)(i) of the FD&C Act). FDA may reevaluate the science related to an authorized health claim and may take action to revoke the claim (see section 403(r)(7)(B) of the FD&C Act (21 U.S.C. 343(r)(7(B)).

Additionally, our regulations, at 21 CFR 10.40(a), provide that we may promulgate regulations necessary to enforce the FD&C Act as appropriate and may initiate such action in any of the ways specified in § 10.25 (21 CFR 10.25). Specifically, § 10.25(b) provides that the Commissioner may initiate a proceeding to revoke a regulation. Accordingly, we are acting within our statutory and regulatory authorities to propose to revoke the authorized health claim for soy protein and a reduced risk of CHD. If this proposed rule is finalized, the use of an authorized health claim would be prohibited and a food that bears the health claim on the label or in labeling would misbrand the food (see section 403(r)(1)(B) of the FD&C Act).

In situations where we determine that the totality of the publicly available scientific evidence does not meet the statutory SSA standard, we may consider whether there is credible evidence to support a “qualified” health claim and what qualifying statements and other information should accompany the claim to ensure that it is truthful and not misleading. If, when we finalize this rule, we conclude there is not SSA, but there is some credible evidence for the use of a qualified health claim about the relationship between soy protein and a reduced risk of CHD, we intend to issue a statement of enforcement discretion for the use of a qualified health claim.

Health claims characterize the relationship between a substance and a reduction in risk of contracting a particular disease or developing a health-related condition (Whitaker v. Thompson, 353 F.3d 947, 950-51 (D.C. Cir.) (upholding FDA's interpretation of what constitutes a health claim), cert. denied, 125 S. Ct. 310 (2004)). The substance must be associated with a disease or health-related condition for which the general U.S. population, or an identified U.S. population subgroup, is at risk (§ 101.14(b)(1)). We analyze the information and data related to a health claim under the framework set out in our 2009 guidance titled, “Evidence-Based Review System for the Scientific Evaluation of Health Claims” (Ref. 1). The 2009 guidance discussed our process for evaluating the scientific evidence for a health claim and the meaning of the significant scientific agreement (SSA) standard in section 403(r)(3) of the FD&C Act (21 U.S.C. 343(r)(3)) and 21 CFR 101.14(c). In a review of a health claim, our first step is to identify the substance, the disease or health-related condition that is the subject of the claim, and the population to which the claim is targeted (Ref. 1).

Next, we consider the totality of publicly available data and information to determine whether the scientific evidence could support a relationship between the substance and the disease or health-related condition. We begin this process by organizing the evidence into categories, such as human studies, meta-analyses, review articles, animal studies, and in vitro studies, so we can thoroughly and systematically assess the evidence during the evaluation process. Each category of evidence may offer us helpful information and a better understanding of the topic; however, only well-designed, well-conducted human studies provide both the level of scientific rigor and generalizability to human populations needed to potentially support a health claim relationship. We focus our review on reports of human intervention studies and observational studies. Of the two types of studies, well-conducted intervention studies provide the strongest evidence of an effect and are the most reliable category of studies for determining a cause-and-effect relationship (Ref. 1). In an intervention study, subjects similar to each other are randomly assigned to either receive the intervention or not to receive the intervention, whereas in an observational study, the subjects (or their medical records) are observed for a certain outcome (i.e., disease). Observational studies lack the controlled setting of intervention studies. In contrast to intervention studies, observational studies cannot determine whether an observed relationship represents a relationship in which the substance caused a reduction in disease risk or if other factors or variables may have contributed to an outcome (Ref. 3). In addition to individual reports of human studies, we also consider other types of data and information such as meta-analyses, review articles, and animal and in vitro studies. These other types of data and information may be useful to help us understand the scientific issues about the substance, the disease, or both, but cannot by themselves support a health claim relationship. Reports that discuss a number of different studies, such as meta-analyses and review articles do not provide sufficient information on the individual studies reviewed in order for us to determine critical elements such as the study population characteristics and the composition of the products used. Similarly, the lack of detailed information on studies summarized in review articles and meta-analyses prevents us from determining whether the studies are flawed in critical elements such as design, conduct of studies, and data analysis. We must be able to review the critical elements of a study to determine whether any scientific conclusions can be drawn from it. We use meta-analyses, review articles, and similar publications to identify reports of additional studies that may be useful to the health claim review and as background about the substance-disease relationship. If additional studies are identified, we evaluate them individually.

We use animal and in vitro studies as background information regarding mechanisms of action that might be involved in any relationship between the substance and the disease. In vitro studies are conducted in an artificial environment and cannot account for a multitude of normal physiological processes, such as digestion, absorption, distribution, and metabolism, which affect how humans respond to the consumption of foods and dietary substances (Ref. 4). Further, the physiology of animals is different than that of humans. Animal and in vitro studies can be used to generate hypotheses or to explore a mechanism of action but cannot adequately support a relationship between the substance and the disease.

We evaluate the individual reports of human studies to determine whether any scientific conclusions can be drawn from each study. The absence of critical factors, such as a control group or a statistical analysis, means that scientific conclusions cannot be drawn from the study (Ref. 5-6). Studies from which we cannot draw any scientific conclusions do not support the health claim relationship, and we eliminate such studies from further review.

Because health claims involve reducing the risk of a disease in people who do not already have the disease that is the subject of the claim, we consider evidence from studies in individuals diagnosed with the disease that is the subject of the health claim only if it is scientifically appropriate to extrapolate to individuals who do not have the disease. The available scientific evidence should demonstrate that: (1) The mechanism(s) for the mitigation or treatment effects measured in the diseased populations are the same as the mechanism(s) for risk reduction effects in non-diseased populations; and (2) the substance affects these mechanisms in the same way in both diseased and healthy people. If such evidence is not available, then we cannot draw any scientific conclusions from studies that use diseased subjects to evaluate the substance/disease relationship. Next, we rate the remaining human intervention and observational studies for methodological quality. This quality rating is based on several criteria related to study design (e.g., use of a placebo-control group versus a non-placebo-control group), data collection (e.g., type of dietary assessment method), the quality of the statistical analysis, the type of outcome measured (e.g., disease incidence versus validated surrogate endpoint), and study population characteristics other than relevance to the U.S. population (e.g., age, smoker versus non-smoker) to evaluate factors such as selection bias and whether important information about the study subjects was gathered and reported. For example, if the scientific study adequately addressed all or most of the criteria related to study design, we would assign a high methodological quality rating to the study. We would assign moderate or low quality ratings based on the extent of the deficiencies or uncertainties in the quality criteria. As noted in our guidance (Evidence-Based Review System for the Scientific Evaluation of Health Claims), this quality rating is based on several factors related to study design, data collection, the quality of the statistical analysis, the type of outcome measured, and study population characteristics other than relevance to the U.S. population (e.g., selection bias and the provision of important subject information [e.g., age, smokers]). (Ref. 1). We would not use studies that are so deficient that scientific conclusions cannot be drawn from them to support the health claim relationship, and we eliminate such studies from further review.

We then evaluate the results of the remaining human studies and then rate the overall strength of the total body of publicly available evidence (Ref. 1). We consider the study type (e.g., intervention, prospective cohort, case-control, cross-sectional), the methodological quality rating previously assigned, the quantity of evidence (number of studies of each type and study sample sizes), whether the body of scientific evidence supports a health claim relationship for the U.S. population or target subgroup, whether study results supporting the proposed claim have been replicated (Ref. 7), and the overall consistency (Ref. 8-9) of the total body of evidence (Ref. 1). Based on the totality of the publicly available scientific evidence, we determine whether such evidence meets that SSA standard to support an authorized health claim (also referred to as “SSA health claim”) for the substance/disease relationship. If the evidence does not meet the SSA standard, then we may consider whether such evidence is credible to support a qualified health claim. If there is credible evidence to support a qualified health claim, then we consider what qualifying language should be included to convey the limits on the level of scientific evidence supporting the relationship or to prevent the claim from being misleading in other ways.

In our reevaluation of the scientific evidence for a relationship between soy protein and reduced risk of CHD, we have used the approach outlined in the 2009 guidance to evaluate the totality of the current publicly available scientific evidence regarding this relationship (see section 403(r)(3)(B) of the FD&C Act). In this section, we present our reevaluation of the totality of the publicly available scientific evidence, including the studies we previously reviewed in promulgating the regulation that authorized the 1999 soy protein and CHD health claim (64 FR 57700), as well as studies published after we authorized the health claim in 1999. The 2009 guidance represents FDA's current thinking on the evaluation of health claims as well as the interpretation and meaning of SSA. Because the 1999 final rule predates that guidance, we acknowledge that our reevaluation of studies previously considered in the 1999 rulemaking may differ in certain respects from the previous evaluation. For the purposes of this review, we have identified the following disease endpoints for use in identifying CHD risk reduction for the purposes of a health claim evaluation: The incidence of coronary events (e.g., myocardial infarction, ischemia), cardiovascular death, coronary artery disease, atherosclerosis, and CHD (Ref. 1). We consider high blood pressure, blood (serum or plasma) total cholesterol (TC), and blood LDL cholesterol levels to be surrogate endpoints for CHD risk (Ref. 1). We use these disease and surrogate endpoints to evaluate the potential effects of soy protein on CHD risk.

For the purposes of the reevaluation, we identified a total of 709 publications, drawn from studies included in the 1999 final rule, comments submitted to the 2007 notice of reevaluation, the 2008 citizen petition, and searches of the more recent literature. These publications consisted of 30 in vitro studies; 85 animal studies; 27 government documents; 163 review articles, meta-analyses, letters, abstracts, and books or book chapters; 11 Web sites; 3 articles written in a foreign language; and 141 publications that did not evaluate the substance/disease relationship. The publications also included 11 observational studies that evaluated the substance/disease relationship and 238 publications describing intervention studies that evaluated the relationship between soy protein intake and CHD risk.

Although useful for background information, review articles, meta-analyses, book chapters, letters, and government reports do not contain sufficient information on the individual studies which they reviewed and, therefore, we could not draw any scientific conclusions from this information. For example, we could not determine factors such as the study population characteristics or the composition of the products used (e.g., food, dietary supplements). Similarly, the lack of detailed information on studies summarized in review articles, meta-analyses, book chapters, letters, and government reports prevents us from determining whether the studies are flawed in critical elements such as design, conduct of studies, and data analysis. We need to be able to review the critical elements of a study to determine whether any scientific conclusions can be drawn from it. As a result, while the review articles, meta-analyses, book chapters, letters, and government reports we identified provided useful background information, they did not provide sufficient information from which scientific conclusions could be drawn regarding soy protein consumption and risk of CHD.

We use animal and in vitro studies as background information regarding mechanisms of action that might be involved in any relationship between the substance and the disease; these studies also can be used to generate hypotheses or to explore a mechanism of action, but they cannot adequately support a relationship between a substance and a disease in humans (Ref. 1, 4). Such studies cannot mimic the normal human physiology that may be involved in the risk reduction of CHD, nor can the studies mimic the human body's response to the consumption of soy protein. Therefore, we cannot draw any scientific conclusions from the animal or in vitro studies regarding soy protein and the risk of CHD in humans, and they provide insufficient data to support a health claim. In accordance with these principles, in our review we considered animal and in vitro studies but determined that they did not provide useful supportive information about the relationship between soy protein consumption and risk of CHD.

For the purposes of this review, we categorized the intervention studies based on whether the subjects: (1) Added soy protein to the diet (supplement) in addition to the subjects' usual diet; (2) were instructed to substitute soy protein for animal protein in their diet; and (3) were provided test diets (feeding studies) with soy protein for animal protein (usually casein) in the control diet. In studies where soy proteins were used as a substitute for animal proteins, changes in the total fat, saturated fat, cholesterol, and dietary fiber content of the diet can occur. A reduced intake of total fat (Ref. 10), saturated fat ((Ref. 10), or cholesterol (Ref. 11) has been shown to lower blood cholesterol, and an increased intake of dietary fiber (Ref. 12) has shown the same (Ref. 10), and we have authorized SSA health claims for reduced risk of CHD based on these substance and disease relationships (§ 101.75, § 101.81). Therefore, to determine the independent effect of soy protein intake on blood cholesterol levels, total fat, saturated fat, cholesterol, and dietary fiber need to be controlled for in the studies. Studies that substituted soy protein for animal protein or feeding studies that did not properly control for these nutrients and/or did not report these nutrients were eliminated from further review. For studies in which soy protein was added to the usual diet, the addition of soy protein should not result in significant changes in the total fat, saturated fat, cholesterol, and dietary fiber in the diet (because soy protein does not have significant amounts of these nutrients) (Ref. 13-15). Therefore, we did not eliminate these types of studies that did not control for and/or did not report these nutrients.

To determine the independent effects of soy protein on blood pressure, studies need to control for the amount of sodium and potassium, because both nutrients influence blood pressure (Ref. 16). Studies that substituted soy protein for animal protein or feeding studies where subjects were provided soy protein in test diets that did not properly control for these nutrients and/or did not report these nutrients were eliminated from further review. For studies that added soy protein to the diet, the addition of soy protein should not result in significant changes in the amount of sodium and potassium in the diet; therefore, we did not eliminate these types of studies that did not control for and/or did not report these nutrients (Ref. 13-15). Furthermore, because the nutrients that affect blood pressure (sodium and potassium) and cholesterol (saturated fat, dietary fiber, and cholesterol) are different, some studies might be appropriate for supporting one surrogate endpoint, but not the other. Thus, for the purposes of this assessment, we discuss some studies twice.

Of the 238 total publications describing intervention studies that evaluated the relationship between soy protein intake and CHD risk, 9 publications did not report data on a FDA-recognized surrogate endpoint of CHD risk (i.e., blood total cholesterol, blood LDL cholesterol, blood pressure) (Ref. 17-25). Because these publications did not report data on one or more surrogate endpoints, we could not draw scientific conclusions about the relationship between soy protein consumption and risk of CHD from these studies (Ref. 1).

The remaining 229 publications described 212 intervention studies that evaluated soy protein intake and CHD risk. Of these 212 intervention studies, scientific conclusions could not be drawn from 154 studies due to significant flaws. These studies are discussed in sections V.C. 1. and V.C. 2. Such studies may have other flaws in addition to those specifically mentioned. This left 58 well-designed, well-conducted intervention studies to include in our evaluation of the totality of the publicly available scientific evidence.

As stated previously in this section, we could not draw scientific conclusions about the relationship between soy protein consumption and risk of CHD from 154 intervention studies due to significant design flaws. These studies include 17 studies that did not include a control group or provide an appropriate control for the comparison to the relative effects of soy protein (Ref. 26-42). Without an appropriate control group, we could not determine if the changes in LDL cholesterol were due to soy protein intake or uncontrolled extraneous factors (Ref. 1). Therefore, we could not draw scientific conclusions about the relationship between soy protein consumption and risk of CHD from these studies

Ten studies did not conduct statistical analyses between the control group and treatment group. The statistical analysis of the substance/disease relationship is a critical factor because it provides the comparison between subjects that consumed soy protein and those that did not consume soy protein (i.e., control) to determine whether there is a reduction in CHD risk (Ref. 43-52). Therefore, we could not draw scientific conclusions about the relationship between soy protein consumption and risk of CHD from these studies.

In eight studies (Ref. 53-60), the duration of the study intervention was too short (less than 3 weeks) to adequately determine if changes in serum cholesterol levels were due to the consumption of soy protein (Ref. 1, 61). Therefore, we could not draw scientific conclusions about the relationship between soy protein consumption and risk of CHD from these studies.

Seventy-six studies, described in 84 publications, that substituted soy protein for animal protein or were feeding studies reported large differences in or did not report information on other dietary components that have an effect on blood cholesterol (e.g., dietary fiber, saturated fat, dietary cholesterol) (Ref. 56, 62-145). Such large differences in nutrient intakes of dietary fiber, saturated fat, or dietary cholesterol make it difficult to clearly delineate what may be causing a change in serum cholesterol levels. Therefore, the results of these studies could not be interpreted, and we could not draw scientific conclusions about the relationship between soy protein consumption and risk of CHD from these studies (Ref. 1).

One study, Zittermann et al. (2004) was a randomized, crossover study (Ref. 1) in which 14 German women consumed 5 cookies made with soy flour or 5 cookies made with wheat flour while they remained on their usual diet for one menstrual cycle (30.8 ± 0.9 days). The composition of the test cookies and of the amount of soy protein in the cookies was not adequately described. Furthermore, while the study reported that subjects were to consume the cookies while they remained on their usual diet, the study reported significantly higher intake of dietary fiber (P <0.0001) in the soy period (cookies made with soy flour) than in the control period. When an intervention study involves providing a whole food rather than a food component, the experimental and control diets should be similar enough that the relationship between the substance and disease can be evaluated (Ref. 1). Because the composition of the test cookies were not adequately described, it is not clear why there are differences in dietary fiber intake between the two groups. Thus, we could not draw scientific conclusions about the relationship between soy protein and CHD when the amounts of other substances that are known to affect the risk of CHD (e.g. dietary fiber) are different between the control and experimental diets (Ref. 1, 146).

Nine studies, described in 11 publications that evaluated soy protein intake and blood cholesterol, contained added phytosterols in the treatment group (Ref. 131-132, 147-155). We have an existing regulation for a SSA health claim for the relationship between plant sterol/stanol esters and reduced risk of CHD; however, because plant sterol/stanol esters can reduce blood cholesterol, it is not possible to clearly delineate what may be causing a change in serum cholesterol levels (Ref. 1). Therefore, the results of these studies could not be interpreted, and we could not draw scientific conclusions about the relationship between soy protein consumption and risk of CHD from these studies.

For the remaining 58 intervention studies from which we could draw scientific conclusions, we used the criteria established by the National Heart, Lung and Blood Institute (NHLBI) to sort studies that measured blood cholesterol into 3 categories: (1) Studies that had subjects with desirable or borderline blood cholesterol (TC <240 mg/dL or LDL-cholesterol less than 160 mg/dL); (2) studies that had subjects with high blood cholesterol (TC >240 or LDL cholesterol >160 mg/dL); and (3) studies that had some subjects with desirable or borderline cholesterol level and other subjects with high cholesterol levels (Ref. 156). Additionally, studies that measured blood pressure were sorted based on criteria established by NHLBI into three categories: (1) Normal (Systolic Blood Pressure (SBP) <120 mmHg or Diastolic Blood Pressure (DBP) <80 mmHg); (2) pre-hypertension (SBP 120 to 139 mmHg or DBP 80 to 89 mmHg); and (3) hypertension (SBP ≥140 mmHg or DBP ≥90 mmHg) (Ref. 157-158). Studies were further sorted by whether the studies added (supplemented) soy protein to the diet, were feeding studies, or were substitution studies. Because some studies measured both blood cholesterol and blood pressure, we discussed these studies twice (see tables 4-8 in Ref. 230).

a. Studies in subjects with desirable or borderline cholesterol levels that added isolated soy protein to the diet.

Carmignani et al. (2014) was a 16-week, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 40 postmenopausal Brazilian women consumed daily 40 g/day placebo powder of maltrodextrin (n=20) or 40 g/day protein powder containing 24 g/day isolated soy protein (90 mg/day naturally occurring isoflavones) (n=20) in addition to their usual diet (Ref. 159). There was no significant difference in blood TC and LDL cholesterol between the soy protein group and the control group.

Liu et al. (2012) was a 6-month, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 120 postmenopausal Chinese women consumed daily 15 g/day milk protein plus 100 mg/day isoflavone supplement (control) (n=60) or 15 g/day isolated soy protein plus 100 mg/day isoflavone supplement (n=60) in addition to their usual diet (Ref. 160). There was no significant difference in the change in blood TC and LDL cholesterol between the milk protein and isoflavone group (control) and the soy protein and isoflavone group.

Santo et al. (2008) was a 28-day, randomized, double-blind, controlled parallel trial of moderate quality in which 30 American men consumed: (1) 25 g/day isoflavone-poor soy protein isolate (1.9 mg/day isoflavones) (n=11); (2) 25 g/day isoflavone-rich soy protein isolate (97 mg/day naturally occurring isoflavones) (n=10); or (3) 25 g/day of milk protein (n=9) (control) mixed with a beverage of their choice in addition to their usual diet (Ref. 161). There were no significant differences in blood TC and LDL cholesterol between the two soy protein isolate treatment groups and the casein control group.

Evans et al. (2007) was a randomized, double-blind, placebo-controlled, crossover trial of moderate quality in which 22 postmenopausal American women consumed: (1) 25 g/day isolated soy protein plus 20 g/day soy lecithin; (2) 25 g/day isolated soy protein plus placebo lecithin; (3) placebo protein (50:50 calcium/sodium caseinate) and 20 g/day soy lecithin; and (4) double placebo (protein placebo and soy lecithin) in addition to their usual diet, for a duration of 4 weeks each (Ref. 162). There was no significant difference in blood TC and LDL cholesterol between the isolated soy protein plus soy lecithin and placebo protein plus soy lecithin treatment period (control). There was also no significant difference in blood TC and LDL between the isolated soy protein plus placebo lecithin and double placebo period (control).

Maesta et al. (2007) was a 16-week, randomized, single-blind, placebo-controlled, parallel trial of moderate quality in which 46 postmenopausal Brazilian women consumed: (1) 25 g/day isolated soy protein (n=10); (2) 25 g/day isolated soy protein, plus resistance exercise (n=14); (3) 25 g/day maltodextrin (control) (n=11); or (4) 25 g/day maltodextrin plus resistance exercise (n=11) (control) in addition to their usual diet (Ref. 163). There was no significant difference in blood TC and LDL cholesterol between the soy protein and control groups.

Kohno et al. (2006) was a two-part, randomized, double-blind, placebo-controlled, parallel trial of moderate quality (Ref. 164). In the first part of the trial, 126 Japanese men and women, in addition to their usual diet, consumed daily 5 g casein (control) (n=61) or 5 g of soybean β-conglycinin (storage protein component of soy protein isolate) in the form of a candy (n=65) for 12 weeks. There was no significant difference between the two diets for blood TC or LDL cholesterol. In the second part of the trial, 95 Japanese men and women consumed daily 5 g casein (n=50) or 5g soybean β-conglycinin (n=45) for 20 weeks. There was no significant difference between the two diets for blood TC or LDL cholesterol.

McVeigh et al. (2006) was a randomized, single-blind, controlled, crossover trial of moderate quality in which 35 Canadian men consumed 32 g/day soy protein isolate depleted of isoflavones (1.64 mg/day), 32 g/day soy protein isolate (62 mg/day isoflavones), or 32 g/day milk protein isolate for a duration of 57 days each (Ref. 165). There was no significant difference between blood TC and LDL cholesterol between the soy protein and casein groups.

Sagara et al. (2004) was a 5-week, randomized, double-blind, placebo-controlled parallel trial of moderate quality in which 50 Scottish men consumed 20 g/day of isolated soy protein powder in biscuits, cereal bars, and bread rolls (n=25) or biscuits, cereal bars, and bread rolls without added soy protein in addition to their usual diets (n=25) (Ref. 166). There was no significant difference in blood TC between the two groups.

Teixeira et al. (2004) was a randomized, controlled, crossover trial of moderate quality in which 14 men American men with type 2 diabetes with nephropathy consumed an estimated 35 g/day of soy protein isolate and casein (control) in addition to their usual diets for a duration of 8 weeks each (Ref. 167). There was no significant difference in blood TC and LDL cholesterol between the soy protein and casein group.

Murray et al. (2003) was a 6-month, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 30 American postmenopausal women consumed: (1) 38 g/day soy protein isolate containing (25 g soy protein) plus 1.0 mg estradiol (n=8); (2) 38 g textured milk protein plus 1.0 mg estradiol (n=7) (control); (3) 38 g/day soy protein isolate containing (25 g soy protein) plus 0.5 mg estradiol (n=8); or (4) 38 g/day textured milk protein plus 0.5 mg estradiol(control) (n=7) in addition to their usual diet (Ref. 168). The baseline TC levels in the 38 g/day textured milk protein plus 1.0 mg estradiol group were significantly higher than the (25 g soy protein) plus 1.0 mg estradiol group. If the baseline cholesterol values between groups are significantly different, then it is difficult to determine if differences at the end of the study were due to the intervention or to differences observed at the beginning of the study (Ref. 1). Thus, we could not draw scientific conclusions from this arm of the study. For the soy protein group plus 0.5 mg estradiol and the textured milk protein plus 0.5 mg estradiol (control) groups, the baseline cholesterol levels were similar and conclusions could be drawn. However, there was no significant difference in blood TC and LDL cholesterol between the soy protein group plus 0.5 mg estradiol and the textured milk protein plus 0.5 mg estradiol control group.

Jayagopal et al. (2002) was a randomized, double-blind, placebo-controlled, crossover trial of moderate quality in which 32 postmenopausal British women with type 2 diabetes consumed 30 g/day of isolated soy protein or 30 g/day of cellulose (control) in addition to their usual diet for a duration of 12 weeks each (Ref. 169). Blood TC and LDL cholesterol was significantly lower (P <0.05) in soy protein period compared to the cellulose period.

Higashi et al. (2001) (trial one) was a randomized, controlled, crossover trial of moderate quality in which 14 Japanese men consumed daily milk or yogurt only (no placebo) and 20 g/day soy protein isolate mixed in milk or yogurt in addition to their usual diet for a duration of 4 weeks each (Ref. 26). There was no significant difference in blood TC and LDL cholesterol between the soy protein period and the control period (milk or yogurt only).

Teede et al. (2001) and Dalais et al., (2003) was a 3-month randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 179 Australian men and postmenopausal women consumed a casein placebo (n=93) or 40 g/day soy protein isolate (n=86) mixed with a beverage twice a day in addition to their usual diet (Ref. 170-171). There was no significant difference in blood TC and LDL cholesterol between the casein control group and soy protein isolate group. In a subgroup analysis of the postmenopausal women (n=55 casein and n=51 soy protein) by Dalais et al. (2003), there was no significant difference in blood TC between the casein control group and soy protein isolate group. However, blood LDL cholesterol was significantly (P <0.05) lower in the soy protein isolate group compared to the casein control group.

Washburn et al. (1999) was a randomized, double-blind, placebo-controlled, crossover trial of moderate quality in which 42 perimenopausal American women consumed daily: (1) 20 g/day complex carbohydrate supplement mixed with a beverage (control); (2) 20 g/day isolated soy protein (34 mg/day naturally occurring phytoestrogens) supplement mixed with a beverage as a single dose; and (3) 20 g/day soy protein supplement (34 mg/day naturally occurring phytoestrogens) mixed with beverages split into two equal doses in addition to their usual diets for 6 weeks each (Ref. 172). Blood TC and LDL cholesterol were significantly (P <0.05) lower in the soy protein groups compared to the control group.

Gooderham et al. (1996) was a 28-day randomized, controlled, parallel trial of moderate quality in which 20 Canadian men consumed daily a supplement containing 60 g/day of soy protein isolate (n=10) or a supplement containing 60 g/day of casein (control) (n=10) in addition to their usual diet (Ref. 173). There was no significant difference in blood TC and LDL cholesterol between the soy protein isolate group and casein group.

b. Studies in subjects with desirable or borderline cholesterol levels that were feeding studies or substitution studies with isolated soy protein.

Mangano et al. (2013) was a 1-year, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 97 postmenopausal American women consumed: (1) 18 g/day isolated soy protein plus 105 mg/day isoflavone tablets (n=25); (2) 18 g/day isolated soy protein plus placebo tablets (n=24); (3) 18 g/day control protein (casein, whey, and egg protein) plus 105 mg/day isoflavone tablets (n=26); or (4) control protein and placebo tablets (n=22) in a beverage or food. Subjects were counseled to reduce animal protein foods by approximately 3 oz/day, which is an amount equivalent to the protein powder provided in the study (Ref. 174). There was no significant difference in blood TC or LDL cholesterol between any of the soy protein groups and the control groups.

Steinberg et al. (2003) was a randomized, double-blind, controlled, crossover trial of moderate quality in which 28 postmenopausal American women consumed: (1) 25 g/day of isolated soy protein (107 mg/day naturally occurring isoflavones); (2) 25 g/day of isolated soy protein depleted of isoflavones (2 mg/day isoflavones); and (3) 25 g/day total milk protein (control) for a duration of 6 weeks each (Ref. 175). Subjects mixed the protein powders with a beverage and were instructed to incorporate the protein into their diet without increasing protein or energy intake. There was no significant difference in blood TC and LDL cholesterol between soy protein groups and milk protein control group.

Bakhit et al. (1994) was a randomized, controlled, crossover trial of moderate quality in which 21 American men consumed muffins containing: (1) 25 g/day isolated soy protein plus 20 g/day of dietary fiber from cellulose; (2) 25 g/day isolated soy protein plus 20 g/day of soybean cotyledon fiber; (3) 25 g/day casein plus 20 g/day soybean cotyledon fiber (control); and (4) 25 g/day casein plus 20 g/day of dietary fiber from cellulose (control) for a duration of 4 weeks each (Ref. 176). Subjects were counseled to incorporate the muffins into a low-fat, low-cholesterol diet. There were no significant differences between isolated soy protein groups and control groups for blood TC and LDL cholesterol.

van Raaji et al. (1981) was a 4-week, controlled, parallel trial of moderate quality in which 69 Dutch men and women were fed an average Western diet with different types of dietary protein incorporated into specifically developed products. The dietary protein groups were: (1) 54 g/day of isolated soy protein (n=24); (2) 17 g/day soy (approximately a 2:1 mixture of casein:soy) (n=20); or (3) 55 g/day casein (control) (n=25) (Ref. 177). Participants were matched for initial serum cholesterol, energy intake, and sex. There was no significant difference in blood TC between the isolated soy protein groups and casein control group. However, blood LDL was significantly lower (P <0.05) in the isolated soy protein group compared to the casein control group.

c. Studies in subjects with desirable or borderline cholesterol levels that added soy foods to the diet.

Takatsuka et al. (2000) was a 60-day, randomized, controlled, parallel trial of moderate quality in which 52 premenopausal Japanese women consumed approximately 16 g/day of soy protein from soy milk (n=27) in addition to their usual diet or followed their usual diet as a control diet (n=25) (Ref. 178). The control diet was a usual diet and therefore not a true placebo. The change in blood TC was significantly lower (P = 0.022) in the soy milk group compared to the control group. However, there was no significant difference in the change in blood LDL cholesterol between the two groups.

Mitchell and Collins (1999) was a 4-week, randomized, controlled, parallel trial of moderate quality in which 10 British men consumed: (1) One liter of soy milk (n=4); (2) one liter of rice milk (control) (n=3); or (3) one liter of semi skimmed cow's milk (control) (n=3) in addition to their usual diets. There was no significant difference in blood TC between groups (Ref. 179).

Murkies et al., (1995) was a 12-week randomized, double-blind, controlled parallel trial of moderate quality in which 47 postmenopausal Australian women consumed 45 g/day of wheat flour with an estimated 4.6 g/day wheat protein (control) (n=24) or 45 g/day soy flour with an estimated 15 g/day of soy protein (n=23) in addition to their usual diet (Ref. 180). There was no significant difference in blood TC between the two groups.

d. Studies in subjects with desirable or borderline cholesterol levels that were feeding studies or substitution studies with soy foods.

Matthan et al. (2007) was a randomized, controlled, crossover trial of moderate quality in which 28 American subjects were fed four diets: (1) Animal protein (control), (2) soybean diet (~37.5 g/day soy protein), (3) soy flour (~37.5 g/day soy protein), and (4) and soy milk (~37.5 g/day soy protein) for a duration of 6 weeks each (Ref. 181). Blood LDL cholesterol was significantly lower (P <0.05) in the soymilk diet period compared to the animal protein diet period (control). However, there was no significant difference in blood TC between the soymilk diet period and the animal protein diet period. Furthermore, there was no significant difference in blood TC or LDL cholesterol between the animal protein diet period (control) and the soybean diet period or the soy flour diet period.

Jenkins et al. (1989) was a controlled, crossover trial of moderate quality in which 11 obese Canadian women who consumed a low calorie diet (1,000 kcal) had 2 meals replaced by soy-based liquid formula made from soy flour and soy protein isolate, and a milk-based liquid formula for a duration of 4 weeks each. The soy formula provided approximately 17 g/day soy protein, and the cow's milk formula provided 18 g/day milk protein (control) (Ref. 182). There was no significant difference in blood TC and LDL cholesterol between the soy formula and the cow's milk formula groups.

Bosello et al. (1988) was a 75-day, controlled, parallel trial of moderate quality in which 24 obese Italian subjects were fed a very low calorie diet (375 kcal/day) for 15 days (Ref. 183). The very low calorie diets were then integrated with a commercial textured preparation that provided approximately 27 g/day of casein (control) or approximately 28 g/day soy protein that was consumed daily for 60 days. The 60-day hypocaloric diet provided a total of 800 kcal/day (375 kcal/day from the very low calorie diet and 425 kcal/day from commercial textured preparation). Blood TC and LDL cholesterol was significantly lower (P <0.01) after consuming the soy protein diet compared to the casein diet.

e. Studies that include subjects with normal, borderline, and high cholesterol that were fed or substituted isolated soy protein in the diet.

Greany et al. (2004) was a randomized, controlled, crossover trial of moderate quality in which 33 postmenopausal American women consumed: (1) 26 g/day of soy protein isolate; (2) 26 g/day soy protein isolate plus probiotic capsules; (3) 26 g/day milk protein; and (4) 26 g/day milk protein plus probiotic capsules for a duration of 6 weeks each (Ref. 184). Subjects were counseled to substitute the protein powders in two divided doses for other protein containing foods in their diet. For the analysis, the soy protein and milk protein diets (control), with or without probiotics, were combined. Blood TC and LDL cholesterol was significantly lower (P <0.05) after consuming the soy protein isolate compared to the milk protein control period.

Wong et al. (1998) was a randomized, controlled, crossover trial of high quality in which 13 American subjects with normal or borderline high cholesterol and 13 American subjects with high cholesterol consumed a National Cholesterol Education Program (NCEP) Step 1 soy protein diet that provided approximately 50 g/day isolated soy protein or an NCEP Step 1 animal protein diet that provided approximately 50 g/day animal protein (control) for a duration of 5 weeks each (Ref. 185). Blood LDL cholesterol was significantly lower (P <0.05) after the soy protein period compared to the animal protein period for both the normal and borderline high subjects and high cholesterol subjects. However, there was no significant difference in blood TC between the soy protein diet and the control diet for both the normal and borderline high subjects and high cholesterol subjects.

Goldberg et al. (1982) was a randomized, controlled, crossover trial of moderate quality in which 12 American subjects with high cholesterol and 4 American subjects with normal or borderline high cholesterol consumed daily: (1) An animal protein diet (control); and (2) an isolated soy protein diet for a duration of 6 weeks each. The soy protein diet contained an estimated 99 g/day of isolated soy protein (Ref. 186). Blood TC and LDL cholesterol in the 12 subjects with high cholesterol was significantly lower (P <0.025) after the soy protein diet compared to the animal protein diet. However, there was no significant difference in blood TC and LDL between the two diets in the four subjects with normal or borderline high cholesterol.

f. Studies in subjects with high cholesterol levels that added isolated soy protein to the diet.

Hoie et al. (2007) was an 8-week, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 88 German subjects consumed: (1) 25 g/day of isolated soy protein in its native, non-denatured form (n=28); (2) 25 g/day of isolated soy protein (n=32); or (3) 25 g/day of milk protein (derived from caseinate and skimmed milk powder) (n=28) (control) in addition to their usual diets (Ref. 187). Blood TC and LDL cholesterol was significantly lower (P <0.001 and P = 0.002, respectively) after consuming the non-denatured isolated soy protein compared to milk protein group. Blood TC cholesterol was also significantly lower (P = 0.008) after consuming isolated soy protein compared to milk protein group. However, there was no significant difference for blood LDL cholesterol after consuming isolated soy protein compared to milk protein group.

Hoie et al. (2006) was a 4-week, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 80 German subjects consumed daily: (1) Ultra-heat-treated chocolate-flavored milk containing 24.4 g/day isolated soy protein and 30.4 g/day milk protein (n=20); (2) 43.3 g/day milk protein (control) (n=20); (3) ultra-heat-treated chocolate flavored milk containing 12.2 g/day isolated soy protein and 15.2 g/day milk protein (n=20); or (4) 21.7 g/day milk protein (control) (n=20) (Ref. 188). There was no significant difference in blood TC or LDL cholesterol between the group that consumed the ultra-heat-treated chocolate-flavored milk containing 24.4 g/day isolated soy protein and 30.4 g/day milk protein group and the control milk protein group. There was also no significant difference in blood TC and LDL cholesterol between the group that consumed ultra-heat-treated chocolate-flavored milk containing 12.2 g/day soy protein and 15.2 g/day milk protein per day (n=20) or the control milk protein group.

Hoie et al. (2005a) was an 8-week, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 77 German subjects consumed 25 g/day soy protein (n=39) or 25 g/day milk protein (derived from caseinate and skimmed milk powder) (control) (n=38) in addition to their usual diets (Ref. 189). Blood LDL cholesterol was significantly lower (P <0.05) in the soy protein group when compared to the casein group. There was no difference in blood TC between the soy protein group and casein group.

Hoie et al. (2005b) was an 8-week, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 117 German subjects consumed: (1) 25 g/day soy protein (n=39); (2) 15 g/day soy protein plus 10 g/day milk protein (derived from caseinate and skimmed milk powder) (n=39); or (3) 25 g/day milk protein (derived from caseinate and skimmed milk powder) (control) (n=39) in addition to their usual diets (Ref. 190). Blood LDL cholesterol was significantly lower (P = 0.002) after consumption of 25 g/day soy protein compared to the 25 g/day casein group. TC was also significantly lower (P = 0.002) after consumption of 25 g/day soy protein compared to the 25 g/day casein group. In the 15 g/day soy protein plus 10 g/day casein group blood LDL cholesterol was significantly lower (P = 0.011) compared to 25 g/day casein control group. TC was also significantly lower (P = 0.001) after consumption of 15 g/day soy protein plus 10 g/day casein compared to 25 g/day casein control group.

Teede et al. (2005) was a 3-month, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 40 postmenopausal Australian women consumed 40 g/day isolated soy protein (n=19) or a casein placebo in addition to their usual diet (n=21) (Ref. 191). There was no significant difference in blood TC or LDL cholesterol between the soy protein and casein group.

Harrison et al. (2004) was a 5-week, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 112 British men and women consumed foods (bread, cracker biscuits, and snack bars) that provided 25 g/day isolated soy protein (n=59) or the same foods without soy protein as a control (n=53) in addition to their usual diet (Ref. 192). There was no significant difference in blood TC and LDL cholesterol between the soy protein and control groups.

Blum et al. (2003) was a randomized, double-blind, placebo-controlled, crossover trial of moderate quality in which 24 postmenopausal Israeli women consumed 25 g/day milk protein (control) and 25 g/day isolated soy protein in addition to their usual diets for a duration of 6 weeks each (Ref. 193). Blood TC and LDL cholesterol was significantly lower (P <0.05) after consuming soy protein isolate compared to milk protein period.

Cuevas et al. (2003) was a randomized, double-blind, controlled, crossover trial of moderate quality in which 18 postmenopausal Chilean women consumed diets providing 40 g/day caseinate (control) and 40 g/day isolated soy protein in addition to an NCEP Step 1 diet for a duration of 4 weeks each (Ref. 194). There was no significant difference in blood TC and LDL cholesterol between the caseinate control diet and soy protein diet.

Gardner et al. (2001) was a 12-week, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 94 postmenopausal American women consumed: (1) 42 g/day total milk protein (control) (n=30); (2) 42 g/day isolated soy protein with isoflavones depleted (3 mg/day) (n=33); or (3) 42 g/day isolated soy protein (80 mg/day naturally occurring isoflavones) (n=31) in addition to their usual diet (Ref. 195). There was no significant difference in blood TC or LDL cholesterol between the isolated soy protein groups and the total milk protein control group.

Hori et al. (2001) was a 3-month, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 21 Taiwanese men consumed: (1) Casein hydrolysate (n=7); (2) 3 g/day of a crude type of soy protein hydrolysate (n=7); or (3) 6 g/day of a crude type of soy protein hydrolysate (n=7) in addition to their usual diet. Blood TC was significantly lower (P <0.05) after consuming 3 g/day of a crude type of soy protein hydrolysate group for 3 months compared to the casein hydrolysate control (Ref. 196). Blood TC was also significantly lower after consuming 6 g/day crude type of soy protein hydrolysate group after 2 and 3 months compared to the casein hydrolysate control. Blood LDL cholesterol was significantly lower (P <0.05) after consuming 3 g/day of a crude type of soy protein hydrolysate group after 2 and 3 months compared to the casein hydrolysate control. Blood LDL cholesterol was also significantly lower (P <0.05) after consuming 6 g/day a crude type of soy protein hydrolysate group after 1, 2, and 3 months compared to the casein hydrolysate group.

g. Studies in subjects with high cholesterol levels that were feeding or substitution studies with isolated soy protein.

Chen et al. (2006) was a 12-week, randomized, double-blind, placebo-controlled, parallel trial of high quality in which 26 Taiwanese subjects on dialysis consumed daily their usual dialysis diet that incorporated 30 g/day milk protein (control) (n=13) or an isolated soy protein diet containing 30 g/day soy protein (n=13) (Ref. 197). Blood TC was significantly lower (P <0.05) in the isolated soy protein diet compared to the milk protein control. There was no significant difference in blood LDL cholesterol between the milk protein control and isolated soy protein diet.

Ma et al. (2005) was a 5-week, randomized, double-blind, controlled, parallel trial of moderate quality in which 159 American subjects consumed daily 28 g/day milk protein supplement (n=78) (control) or a 32 g/day isolated soy protein supplement (n=81) in a beverage. Subjects were counseled to modify their protein and carbohydrate intake to account for the protein supplement intake. There was no significant difference in blood TC and LDL cholesterol between the two diets (Ref. 198).

West et al. (2005) and Hilpert et al. (2005) both discuss a randomized, double-blind, controlled, crossover trial of high quality in which 32 American subjects were fed an NCEP Step 1 diet that incorporated 25 g/day milk protein or 25 g/day soy protein isolate for a duration of 6 weeks each (Ref. 199-200). On each diet, 15 g of the protein supplement was consumed in a muffin while the remaining protein supplement was provided to the subjects to integrate into the meals provided. There was no significant difference in blood TC and LDL cholesterol between the milk protein and soy protein isolate diets.

Jenkins et al. (2002 a and b) was a randomized, single-blind, controlled, crossover trial of moderate quality in which 41 Canadian men and women were fed an NCEP Step 2 diet in which the main protein containing foods were replaced with test foods made with: (1) Approximately 60 g/day dairy and egg protein; (2) 50 g/day of soy protein isolate (10 mg/day naturally occurring isoflavones); and (3) 50 g/day soy protein isolate (73 mg/day naturally occurring isoflavones) for a duration of 1 month each (Ref. 201-202). The percent change in blood TC and LDL cholesterol was significantly lower (P <0.01) after consuming the soy protein diets compared to the dairy and egg protein diet (control).

Lichtenstein et al. (2002) was a randomized, double-blind, controlled, crossover, feeding trial of moderate quality in which 42 American men and women consumed diets of: (1) Isolated soy protein depleted of isoflavones (25 g soy protein/1,000 kcal); (2) isolated soy protein enriched with isoflavones (25 g soy protein plus 50 mg isoflavones/1,000 kcal); (3) animal protein with no added isoflavones (25 g animal protein/1,000 kcal); and (4) animal protein with added isoflavones (25 g animal protein and 50 mg isoflavones/1,000 kcal) for a duration of 6 weeks each (Ref. 203). The mean soy intake for women was 55 g/day and 71 g/day for men. The treatment effects for blood TC and LDL cholesterol were significantly lower (P = 0.017 and P = 0.042, respectively) after consuming the soy protein diets compared to the animal protein diets. For 20 subjects with LCL-C >160 mg/dL, the treatment effects for blood TC and LDL-C were significantly lower (P <0.001 and P = 0.003) after consuming the soy protein diets compared to the animal protein diets. These data were also reported in Wang et al., (2004) and Desroches et al., (2004) (Ref. 204-205).

Van Horn et al. (2001) was a 6-week, randomized, controlled, parallel trial of high quality in which 126 postmenopausal American women consumed an NCEP Step 1 diet in which they isocalorically substituted: (1) Oats and 29 g/day milk protein (n=31) (control); (2) wheat and 29 g/day isolated soy protein (n=31); (3) oats and 29 g/day isolated soy protein (n=31); or (4) wheat and 29 g/day milk protein (n=32) (control) for other carbohydrates and dairy type foods (Ref. 206). There was no significant difference in blood TC or LDL cholesterol between the two control and the two soy protein diets.

h. Studies in subjects with high cholesterol that added soy foods to the diet.

Gardner et al. (2007) was a 4-week, randomized, single-blind, controlled, crossover trial of high quality in which 28 American men and women consumed daily: (1) 1 percent cow's milk (control); (2) whole bean soy milk; and (3) soy protein isolate milk, in addition to an American Heart Association diet (Ref. 207). The whole bean soy milk and the soy protein isolate milk provided 25 g/day of soy protein, and the 1 percent cow's milk provided 25 g/day of milk protein. Blood LDL cholesterol was a significantly lower (P = 0.02) after consuming whole bean soy milk when compared to 1 percent cow's milk. Blood LDL cholesterol was also significantly lower (P = 0.02) after consuming the soy protein diet compared to the 1 percent cow's milk diet.

i. Study in subjects with high cholesterol that were fed soy foods.

Jenkins et al. (2000) was a randomized, controlled, crossover trial of moderate quality in which 25 Canadian men and women consumed daily an NCEP Step 2 diet that incorporated: (1) A commercial breakfast cereal containing 8 g/day wheat protein (control); and (2) a breakfast cereal made with 70 percent soy flour that provided 36 g/day soy protein for a duration of 3 weeks each (Ref. 208). There was no significant difference between the wheat protein cereal (control) period and soy flour cereal diet period for blood TC and LDL cholesterol.

Twenty-eight studies, described in 30 publications, either substituted soy protein in the diet or were feeding studies. These studies did not control for or provide information on sodium and potassium intake in the diet (Ref. 44, 55, 66, 74, 77, 84, 91, 96-97, 99, 114, 116, 123, 125-126, 131-132, 139-140, 144, 149-151, 153-154, 181, 201-202, 208-209). Because sodium and potassium intake also influence blood pressure, the independent effects of soy protein intake and blood pressure could not be determined. Therefore, we could not draw scientific conclusions about the relationship between soy protein consumption and risk of CHD from these studies.

Four studies did not include an appropriate control protein for a comparison of the relative effects of soy protein (Ref. 40, 42, 210-211). Without an appropriate control group, it cannot be determined if the changes in SBP or DBP were due to soy protein intake or uncontrolled, extraneous factors. Therefore, we could not draw scientific conclusions about the relationship between soy protein consumption and risk of CHD from these studies.

Chiechi et al. (2002) was a 6-month, randomized, parallel trial in which 67 subjects with pre-hypertension (SBP 120 to 139 mmHg or DBP 80 to 89 mmHg) consumed their usual diet (n=43) or their usual diet plus a soy food serving each day (e.g. soy milk, miso soup, tofu, tempeh, or soy beans) (n=34) (Ref. 142). Subjects in the soy group also exchanged two meals twice a week with two meals from a study menu that was based on traditional Mediterranean recipes and soy or soy products. Approximately 50 percent of subjects in the soy group dropped out of the study compared to 20 percent in the control group. Therefore, the dropout rate in the treatment group makes the results of this study difficult to interpret. A high dropout rate can introduce bias because it changed the number of subjects in the treatment group and may also have changed the group's composition compared to the control group. In addition to a high dropout rate, the study had other quality issues (e.g., information on study blinding was not reported, adequate descriptions were not provided for the composition of the background diets or the amount of soy protein in the diets), the study measured biomarkers (SBP or DBP) instead of clinical outcomes (e.g., incidence of CHD). Therefore, this study is so deficient in methodological quality that it is considered to be of low-quality design (Ref. 1) and, as a result, we could not draw scientific conclusions regarding the relationship between soy protein intake and reduced risk of CHD.

a. Studies in subjects with normal or pre-hypertension (SBP <139 mmHg or DBP <89 mmHg).

Anderson et al. (2007) was a 16-week, randomized, single-blind, controlled, parallel trial of moderate quality in which 35 obese American women with pre-hypertension (SBP 120 to 139 mmHg or DBP 80 to 89 mmHg) were fed daily 3 meal replacement shakes containing approximately 22 g/day of casein (control) (n=18) or 21 g/day isolated soy protein (n=17) each (Ref. 89). There was no significant difference in SBP or DBP between the casein and soy protein diet.

Azadbakht et al. (2007) was a randomized, controlled, crossover trial of moderate quality in which 42 postmenopausal Iranian women with pre-hypertension (SBP 120 to 139 mmHg or DBP 80 to 89 mmHg) consumed daily: (1) A Dietary Approaches to Stop Hypertension (DASH) control diet; (2) a 30 g/day soy protein diet; and (3) a 30 g/day soy nut diet for a duration of 8 weeks each (Ref. 65). The soy protein and soy nut diets were the same as the DASH diet with soy protein and soy nuts being substituted for red meat for the control diet. There was no significant difference in SBP or DBP between the DASH control diet and the soy protein and soy nut diets.

Evans et al. (2007) was a randomized, double-blind, placebo-controlled, crossover trial of moderate quality in which 22 pre-hypertensive (SBP 120 to 139 mmHg or DBP 80 to 89 mmHg), postmenopausal American women consumed: (1) 25 g/day isolated soy protein plus 20 g/day soy lecithin; (2) 25 g/day isolated soy protein plus placebo lecithin; (3) placebo protein (50:50 calcium/sodium caseinate) and 20 g/day soy lecithin; and (4) double placebo (protein placebo and soy lecithin) in addition to their usual diet for a duration of 4 weeks each (Ref. 162). There was no significant difference in SBP or DBP between the soy protein plus placebo lecithin group and the double placebo group (control) or between the soy protein plus soy lecithin group and the placebo protein plus soy lecithin period (control).

Harrison et al. (2004) was a 5-week, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 112 British men and women with pre-hypertension (SBP 120 to 139 mmHg or DBP 80 to 89 mmHg) consumed foods (bread, cracker biscuits, and snack bars) that provided 25 g/day isolated soy protein (n=59) or the same foods without soy protein as a control (n=53) in addition to their usual diet (Ref. 192). There was no significant difference in SBP and DBP between the soy protein and control groups.

Cuevas et al. (2003) was a randomized, double-blind, controlled, crossover trial of moderate quality in which 18 pre-hypertensive (SBP 120 to 139 mmHg or DBP 80 to 89 mmHg) postmenopausal Chilean women consumed diets providing 40 g/day caseinate (control) or 40 g/day isolated soy protein in addition to an NCEP Step 1 diet for a duration of 4 weeks each (Ref. 194). There was no significant difference in SBP or DBP between the soy protein diet and caseinate control diet.

Teede et al. (2001) was a 3-month randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 179 pre-hypertensive (SBP 120 to 139 mmHg or DBP 80 to 89 mmHg) Australian men and postmenopausal women consumed a casein placebo (n=93) or 40 g/day soy protein isolate mixed with a beverage twice a day (n=86) in addition to their usual diet (Ref. 170). SBP was significantly lower (P <0.05) in the soy protein isolate group compared to casein control group. However, there was no significant difference in DBP between the casein control group and soy protein isolate group.

Washburn et al. (1999) was a randomized, double-blind, placebo-controlled, crossover trial of moderate quality in which 42 pre-hypertensive (SBP 120 to 139 mmHg or DBP 80 to 89 mmHg), perimenopausal American women consumed: (1) A complex carbohydrate supplement (20 g/day) mixed with a beverage (control); (2) 20 g/day isolated soy protein supplement mixed with a beverage as a single dose; and (3) 20 g/day soy protein supplement mixed with beverages split into two equal doses in addition to their usual diet for a duration of 6 weeks each (Ref. 172). There was no difference in SBP or DBP between the soy protein supplement mixed with a beverage as a single dose period and the complex carbohydrate control period. However, SBP and DBP were significantly lower (P <0.05) after consuming the 20 g/day soy protein supplement mixed with beverages split into two equal doses compared to the complex carbohydrate supplement.

b. Studies in normotensive or pre-hypertensive (SBP <39 mmHg or DBP <89 mmHg) and hypertensive subjects (SBP ≥140 mmHg or DBP ≥90 mmHg).

He et al. (2005) was a 12-week, randomized, double-blind, parallel trial of moderate quality in which 276 Chinese men and women with pre-hypertension (SBP 120 to 139 mmHg or DBP 80 to 89 mmHg) or hypertension (SBP ≥140 mmHg or DBP ≥90 mmHg) consumed cookies containing 40 g/day complex carbohydrates from wheat (n=139) (control) or cookies with 40 g/day isolated soy protein (n=137) (Ref. 212). Subjects were instructed to reduce other food intake to keep total energy intake constant. Most subjects consumed the cookies in place of their usual breakfast or usual lunch. SBP and DBP were significantly (P <0.001) lower for those who consumed the soy protein cookies compared to the wheat cookies (control).

Sagara et al. (2004) was a 5-week randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 50 Scottish men with pre-hypertension (SBP 120 to 139 mmHg or DBP 80 to 89 mmHg) or hypertension (SBP ≥140 mmHg or DBP ≥90 mmHg) consumed 20 g/day of isolated soy protein powder in biscuits, cereal bars, and bread rolls (n=25) or biscuits, cereal bars, and bread rolls without added soy protein in addition to their usual diets (n=25) (Ref. 166). There was no significant difference in SBP or DBP between the soy protein and control group.

c. Studies in hypertensive subjects (SBP ≥140 mmHg or DBP ≥90 mmHg).

Webb et al. (2008) was a 5-day, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 25 hypertensive (SBP ≥140 mmHg or DBP ≥90 mmHg) British men and women with CHD consumed 25.7 g/day soy protein isolate (n=13) or 25.7 g/day milk protein isolate (n=12) in addition to their usual diets (Ref. 60). There was no significant difference in SBP or DBP between the soy protein isolate group and the control milk protein isolate group.

Jayagopal et al. (2002) was a randomized, double-blind, placebo-controlled, crossover trial of moderate quality in which 32 hypertensive (SBP ≥140 mmHg or DBP ≥90 mmHg) postmenopausal British women with type 2 diabetes consumed 30 g/day of isolated soy protein or 30 g/day of cellulose (control) in addition to their usual diet for a duration of 12 weeks each (Ref. 169). There was no significant difference in SBP and DBP between the control diet and the soy protein diet.

Rivas et al. (2002) was a 3-month randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 40 hypertensive (SBP ≥140 mmHg or DBP ≥90 mmHg) Spanish men and women consumed daily 1 liter of soy milk (18 g/day soy protein) or 1 liter of cow's milk (15.5 g/day protein) in addition to their usual diet (Ref. 213). SBP and DBP was significantly lower (P <0.0001) in the soy milk group compared to the cow's milk group.

FDA identified 11 observational studies that evaluated soy protein and CHD risk (Ref. 214-224). All of these observational studies calculated soy protein intake from estimated dietary intake. In observational studies that calculated nutrient intake from conventional foods, measures of soy protein intake were based on recorded dietary intake methods such as food frequency questionnaires, diet recalls, or diet records, in which the type and amount of foods consumed were estimated. A common weakness of observational studies is the limited ability to ascertain the actual food or nutrient intake for the population studied as a result of poor memory, over- or underestimation of portion sizes, and recall bias (Ref. 225). Furthermore, the nutrient content of foods can vary due to a number of factors, including soil composition, food processing and cooking procedures, and storage conditions (e.g., duration, temperature). Thus, we cannot ascertain an accurate amount of soy protein consumed based merely on subjects' reports of dietary intake of foods.

In addition, soy foods contain not only soy protein, but also other nutrients that may be associated with the metabolism of soy protein or the pathogenesis of CHD. Therefore, because soy protein containing foods consist of many nutrients and substances, it is difficult to study the nutrient or food components in isolation (Ref. 3). For studies based on recorded dietary intake of such foods, it is not possible to accurately determine whether any observed effects of soy protein on coronary heart disease risk were due to: (1) Soy protein alone; (2) interactions between soy protein and other nutrients; (3) other nutrients acting alone or together; or (4) decreased consumption of other nutrients or substances contained in foods displaced from the diet by the increased intake of soy protein containing foods. In some instances, epidemiological studies based on the recorded dietary intake of conventional foods may indicate a benefit for a particular nutrient with respect to a disease; however, it is subsequently demonstrated in an intervention study that the nutrient-containing dietary supplement does not confer a benefit or actually increases risk of the disease (Ref. 226). For example, previous epidemiological studies reported an association between fruits and vegetables high in beta-carotene and a reduced risk of lung cancer (Ref. 227). However, subsequent intervention studies, the Alpha-Tocopherol and Beta Carotene Prevention Study (ATBC) and the Carotene and Retinol Efficiency Trial (CARET), demonstrated that beta-carotene supplements increase the risk of lung cancer in smokers and asbestos-exposed workers, respectively (Ref. 228-229). These studies illustrate that the effect of a nutrient provided as a dietary supplement exhibits different health effects compared to when it is consumed as part of a usual diet among many other food components. Furthermore, these studies demonstrate the potential public health risk of relying on results from epidemiological studies in which the effect of a nutrient is based on recorded dietary intake of conventional foods as the sole source for concluding that a relationship exists between a specific nutrient and disease risk (i.e., the effect could actually be harmful).

For the reasons provided in this section, scientific conclusions cannot be drawn from observational studies on foods for soy protein as a food ingredient or component of food.

In evaluating the scientific evidence using our evidence-based review system (Ref. 1), we considered the strength of evidence for a relationship between soy protein intake and reduced risk of CHD. When evaluating the strength of the evidence, we consider study types, methodological quality, quantity of evidence for and against the claim (taking into account the numbers of various types of studies and study sample sizes), relevance to the U.S. population or target subgroup, replication of study results supporting the claim, and overall consistency of the evidence (beneficial effect, no effect) (Ref. 1). For the outcome of an intervention study to demonstrate an effect, the validated surrogate or clinical endpoint evaluated in the intervention group should be statistically significantly different from the same validated surrogate or clinical endpoint evaluated in the control group (P <0.05). After assessing the totality of the scientific evidence, we then determine whether there is SSA to support an authorized health claim, or credible evidence to support a qualified health claim.

Our decision about whether to authorize a health claim represents our determination as to whether there is significant scientific agreement among qualified experts that the publicly available scientific evidence supports the substance/disease relationship that is the subject of a proposed health claim. The SSA standard is intended to be a strong standard that provides a high level of confidence in the validity of the substance/disease relationship. SSA occurs well after the stage of emerging science, where data and information permit an inference, but does not require consensus based on unanimous and incontrovertible scientific opinion. We explained in our 2009 guidance (Ref. 1) that we may evaluate new information that becomes available to determine whether it necessitates a change to an existing SSA claim to maximize the public health benefit of our health claims review. The 2009 guidance represents our current thinking on the meaning of the SSA standard in section 403(r)(3) of the FD&C Act and § 101.14(c) and the process for evaluating the scientific evidence for a health claim pursuant to these authorities.

As noted in section V, we reevaluated, consistent with the 2009 guidance (Ref. 1), the studies included in the 1999 final rule as well as new studies that were published since the original review. As discussed in section V.C and D, the totality of the scientific evidence includes 58 well-designed, well-executed intervention studies. Of these 58 studies, 46 are intervention studies of high or moderate quality that measured blood TC or LDL cholesterol, and 12 are intervention studies of high or moderate quality that measured SBP or DBP. The results of these studies were inconsistent and not conclusive.

Of the 46 studies intervention studies of high or moderate quality that measured blood TC or LDL cholesterol, 25 studies were conducted on subjects with desirable or borderline cholesterol levels, defined as a blood TC less than 240 mg/dL or LDL cholesterol less than 160 mg/dL; 18 were conducted on subjects with high TC levels, defined as TC levels less than 240 mg/dL or LDL cholesterol greater than or equal to 160 mg/dL; and 3 studies included subjects with desirable or borderline TC levels and subjects with high TC levels. Of the 46 intervention studies that looked at the relationship between blood TC and/or LCL cholesterol and soy protein intake, only 19 intervention studies showed a benefit in significantly reducing the risk of CHD, while the other 27 intervention studies did not. Study findings also were inconsistent regardless of whether soy protein was added to diet as a supplement or whether the studies were substitution or feeding studies. The study findings also were inconsistent regardless of the study size (10 subjects to 179 subjects) or the dose of soy protein (3 g to 92 g/day). Of the 12 high or moderate quality intervention studies that measured SBP or DBP from which a conclusion could be drawn, only 4 showed a benefit in lowering SBP or DBP with soy protein consumption, while the other 8 studies did not show a benefit. Again, the study findings were inconsistent regardless of baseline SBP or DBP, study size (18 subjects to 276 subjects), or dose (18 g to 60 g/day). Consistency of findings among similar and different study designs is important for evaluating causation and the strength of scientific evidence (Ref. 1). The totality of the evidence does not provide a basis on which experts would find SSA because of the high degree of inconsistency of findings across similar and different studies with high or moderate methodological quality. This degree of inconsistency would not be seen when SSA exists because, when there is SSA, we would find most of the studies to consistently find a beneficial relationship between a substance and a disease risk.

Although there is some evidence that suggests a relationship between soy protein intake and reduced risk of CHD, the strength of the totality of the current, publicly available scientific evidence, discussed in sections V and VI and the references cited therein, which includes many studies that post-date the publication of our 1999 rule, is inconsistent and not conclusive. See also tables 4-8 in Ref. 230. The additional evidence now available to us includes a number of new studies that do not support the relationship, and a number of studies that are inconclusive that also do not support a relationship. This combined body of evidence represents the totality of the scientific evidence that is currently available. We have now evaluated this entire body of evidence, which consists of the studies in the 1999 rule as well as new evidence published since that time, using the evidence based process described in our 2009 guidance. The totality of the evidence, which includes the new, non-supportive studies, does not support the statutory standard for authorizing a health claim. We have determined that the totality of the scientific evidence does not provide significant scientific agreement, among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported. Therefore, we have tentatively concluded that, currently, there is not significant scientific agreement among experts, under section 403(r)(3)(B)(i) of the FD&C Act, that a health claim about a relationship between soy protein intake and CHD risk is supported by the evidence. We request comment and any supporting data and information concerning this tentative conclusion. However, while the totality of the publicly available scientific evidence does not support a finding of SSA, if, when we finalize this rule, we conclude there is not SSA, but there is some credible evidence for the use of a qualified health claim about the relationship between soy protein and a reduced risk of CHD, we intend to issue a statement of enforcement discretion for the use of a qualified health claim.

In the 1999 soy protein final rule authorizing the use of a health claim regarding soy protein and the risk of CHD (64 FR 57700) (now codified at § 101.82) (the 1999 authorized soy protein health claim), the petitioner determined that use of soy as a dietary protein is generally recognized as safe. Under the health claim petition process, we evaluate whether the proponent of the claim demonstrates, to FDA's satisfaction, that the food ingredient is “safe and lawful” under the applicable food safety provisions of the FD&C Act. In the 1999 soy protein final rule, we concluded that there was not sufficient evidence to challenge the petitioner's assertion that soy protein ingredients are GRAS. The petitioner met the showing required by § 101.14(b)(3)(ii) that the substance be “safe and lawful.” We have reviewed the scientific evidence relative to the safety of soy protein as a food ingredient and the evidence does not change our previous conclusion that the use of soy protein at the levels necessary to justify a claim has been demonstrated, to our satisfaction, to be safe and lawful under the applicable food safety provisions of the FD&C Act.

As discussed above, FDA may reevaluate the science related to an authorized health claim and may take action to revoke the claim (see section 403(r)(7)(B) of the FD&C Act (21 U.S.C. 343(r)(7)(B)). Based on our review of the totality of the publicly available scientific evidence, we have tentatively concluded that the SSA standard is not met for a relationship between soy protein and reduced risk of CHD. Therefore, we are proposing to revoke the soy protein and reduced risk of CHD health claim in § 101.82.

We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, Executive Order 13771, 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). Executive Order 13771 requires that the costs associated with new regulations shall “be offset by the elimination of existing costs associated with at least two prior regulations.” It has been determined that this proposed rule is an action that does not impose more than de minimis costs as described below and thus is not a regulatory or deregulatory action for purposes of Executive Order 13771. This proposed rule is a significant regulatory action under 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. Because up to 40 small businesses could be required to relabel one or more products, we find that the proposed rule may 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 $148 million, using the most current (2016) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would not result in any year expenditure that meets or exceeds this amount.

The costs of this rule are relabeling the estimated 200 to 300 products currently making the health claim. We estimate total annualized costs of $35,000 to $81,000, when the relabeling costs are annualized over 20 years at a 7-percent discount rate. The initial, one-time costs are $370,000 to $860,000.

The benefit of this rule is better information for the consumers who are considering purchasing products with soy protein. This may generate an unknown amount of increased consumer surplus. Some consumers may react to this new information by switching their consumption to products that they enjoy more, or products that still have an authorized health claim. We request public comment on how many consumers are likely to react to the changes in health claims caused by this proposed rule, and what the nature of their reaction will be. By basing their consumption decisions on more recent and accurate scientific information, they will get more consumer surplus, in the form of enjoyment and/or potential health benefits, from the bundle of products they consume.

The Economic Analysis of Impacts of the proposed rule performed in accordance with Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act, and the Unfunded Mandates Reform Act is available at https://www.regulations.gov under the docket number for this proposed rule and at: https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

We intend that the effective date for a final rule resulting from this rulemaking be 30 days after the final rule's date of publication in the Federal Register.

With respect to a compliance date, we intend that any adjustments to a product's labeling occur in a manner consistent with our uniform compliance date (see 81 FR 85156, November 25, 2016). Thus, if we issue a final rule before December 31, 2018, then the compliance date would be January 1, 2020.

We have determined under 21 CFR 25.32(p) that this action, revoking a health claim, is categorically excluded from an environmental assessment or an environmental impact statement.

FDA tentatively concludes that this proposed rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

FDA has analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of the Executive order 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 law conflicts with the exercise of Federal authority under the Federal statute.” Federal law includes an express preemption provision that preempts “any requirement respecting any claims of the type described in [21 U.S.C. 343(r)(1)] made in the label or labeling of food that is not identical to the requirement of [21 U.S.C. 343(r)] * * *.” 21 U.S.C. 343-1(a)(5). However, the statutory provision does not preempt any State requirement respecting a statement in the labeling of food that provides for a warning concerning the safety of the food or component of the food (Pub. L. 101-535, section 6, 104 Stat. 2353 (1990)). If this proposed rule is made final, the final rule would revoke the health claim related to soy protein and coronary heart disease in the label or labeling of food under 21 U.S.C. 343(r).

The following references are on display in the Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 101 be amended as follows:

The Postal Service is proposing to amend DMM sections 705.20, eInduction Option, 705.22, Seamless Acceptance Program, and 705.23, Full-Service Automation Option, to add the applicable verification descriptions, error thresholds, and postage assessments, standards. These standards have been made available to the public via Publication 6850, Publication for Streamlined Mail Acceptance for Letters and Flats, available at https://postalpro.usps.com, which also contains additional information on the verification processes.

Although we are exempt from the notice and comment requirements of the Administrative Procedure Act (5 U.S.C. 553(b), (c)) regarding proposed rulemaking by 39 U.S.C. 410(a), we invite public comments on the following proposed revisions to Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM), incorporated by reference in the Code of Federal Regulations. See 39 CFR 111.1. Accordingly, 39 CFR part 111 is proposed to be amended as follows:

Blanchard submitted a petition under 40 CFR 260.20 and 260.22(a). Section 260.20 allows any person to petition the Administrator to modify or revoke any provision of parts 260 through 266, 268 and 273. Section 260.22(a) specifically provides generators the opportunity to petition the Administrator to exclude a waste on a “generator specific” basis from the hazardous waste lists. EPA bases its proposed decision to grant the petition on an evaluation of waste-specific information provided by the petitioner. This decision, if finalized, would conditionally exclude the petitioned waste from the requirements of hazardous waste regulations under the Resource Conservation and Recovery Act (RCRA).

If finalized, EPA would conclude that Blanchard's petitioned waste is non-hazardous with respect to the original listing criteria. EPA would also conclude that Blanchard's reclamation process minimizes short-term and long-term threats from the petitioned waste to human health and the environment.

EPA is proposing to approve the delisting petition submitted by Blanchard to have the residual solids excluded, or delisted from the definition of a hazardous waste. The residual solids are listed as F037. Blanchard's residual solids are listed as a hazardous waste, based on the potential presence of Appendix VII inorganic constituents of concern, lead and chromium, and Appendix VII organic constituents of concern benzene, benzo(a)pyrene and chrysene.

Blanchard's petition requests an exclusion from the F037 waste listing pursuant to 40 CFR 260.20 and 260.22. Blanchard does not believe that the petitioned waste meets the criteria for which EPA listed it. Blanchard also believes no additional constituents or factors could cause the waste to be hazardous. EPA's review of this petition included consideration of the original listing criteria and the additional factors required by the Hazardous and Solid Waste Amendments of 1984 (HSWA). See section 3001(f) of RCRA, 42 U.S.C. 6921(f), and 40 CFR 260.22 (d)(1)-(4) (hereinafter all sectional references are to 40 CFR unless otherwise indicated). In making the initial delisting determination, EPA evaluated the petitioned waste against the listing criteria and factors cited in §§ 261.11(a)(2) and (a)(3). Based on this review, EPA agrees with the petitioner that the waste is non-hazardous with respect to the original listing criteria. If EPA had found, based on this review, that the waste remained hazardous based on the factors for which the waste was originally listed, EPA would have proposed to deny the petition. EPA evaluated the waste with respect to other factors or criteria to assess whether there is a reasonable basis to believe that such additional factors could cause the waste to be hazardous. EPA considered whether the waste is acutely toxic, the concentration of the constituents in the waste, their tendency to migrate and to bioaccumulate, their persistence in the environment once released from the waste, plausible and specific types of management of the petitioned waste, the quantities of waste generated, and waste variability. EPA believes that the petitioned waste does not meet the listing criteria and thus should not be a listed waste. EPA's proposed decision to delist waste from Blanchard is based on the information submitted in support of this rule, including descriptions of the wastes and analytical data resulting from Blanchard's delisting demonstration conducted on the petitioned waste.

If the residual solids are delisted, contingent upon approval of the delisting petition, storage containers with Blanchard's delisted residual solids will be transported to an authorized, solid waste landfill (e.g. RCRA Subtitle D landfill, commercial/industrial solid waste landfill, etc.) for disposal. Any plans for recycling must be addressed through the Hazardous Waste Recycling regulations.

RCRA section 3001(f) specifically requires EPA to provide a notice and an opportunity for comment before granting or denying a final exclusion. Thus, EPA will not grant the exclusion until it addresses all timely public comments (including those at public hearings, if any) on this proposal.

RCRA section 3010(b)(1) at 42 USCA 6930(b)(1), allows rules to become effective in less than six months when the regulated facility does not need the six-month period to come into compliance. That is the case here, because this rule, if finalized, would reduce the existing requirements for persons generating hazardous wastes.

EPA believes that this exclusion should be effective immediately upon final publication because a six-month deadline is not necessary to achieve the purpose of section 3010(b), and a later effective date would impose unnecessary hardship and expense on this petitioner. These reasons also provide good cause for making this rule effective immediately, upon final publication, under the Administrative Procedure Act, 5 U.S.C. 553(d).

Because EPA is issuing this exclusion under the Federal RCRA delisting program, only states subject to Federal RCRA delisting provisions would be affected. This would exclude states which have received authorization from EPA to make their own delisting decisions.

EPA allows states to impose their own non-RCRA regulatory requirements that are more stringent than EPA's, under section 3009 of RCRA, 42 U.S.C. 6929. These more stringent requirements may include a provision that prohibits a Federally issued exclusion from taking effect in the state. Because a dual system (that is, both Federal (RCRA) and state (non-RCRA) programs) may regulate a petitioner's waste, EPA urges petitioners to contact the state regulatory authority to establish the status of their wastes under the state law.

EPA has also authorized some states (for example, Louisiana, Oklahoma, Georgia, Illinois) to administer a RCRA delisting program in place of the Federal program, that is, to make state delisting decisions. Therefore, this exclusion does not apply in those authorized states unless that state makes the rule part of its authorized program. If Blanchard transports the delisted waste to or manages the delisted waste in any state with delisting authorization, Blanchard must obtain delisting authorization from that state before it can manage the delisted waste as non-hazardous in the state.

EPA published an amended list of hazardous wastes from non-specific and specific sources on January 16, 1981, as part of its final and interim final regulations implementing section 3001 of RCRA. EPA has amended this list several times and published it in 40 CFR 261.31 and 261.32.

EPA lists these wastes as hazardous because: (1) The wastes typically and frequently exhibit one or more of the characteristics of hazardous wastes identified in Subpart C of part 261 (that is, ignitability, corrosivity, reactivity, and toxicity), (2) the wastes meet the criteria for listing contained in § 261.11(a)(2) or (a)(3), or (b) the wastes are mixed with or derived from the treatment, storage or disposal of such characteristic and listed wastes and which therefore become hazardous under § 261.3(a)(2)(iv) or (c)(2)(i), known as the “mixture” or “derived-from” rules, respectively.

Individual waste streams may vary, however, depending on raw materials, industrial processes, and other factors. Thus, while a waste described in these regulations or resulting from the operation of the mixture or derived-from rules generally is hazardous, a specific waste from an individual facility may not be hazardous.

For this reason, 40 CFR 260.20 and 260.22 provide an exclusion procedure, called delisting, which allows persons to prove that EPA should not regulate a specific waste from a particular generating facility as a hazardous waste.

A delisting petition is a request from a facility to EPA or an authorized state to exclude wastes from the list of hazardous wastes. The facility petitions EPA because it does not consider the wastes hazardous under RCRA regulations.

In a delisting petition, the petitioner must show that wastes generated at a particular facility do not meet any of the criteria for which the waste was listed. The criteria for which EPA lists a waste are in part 261 and further explained in the background documents for the listed waste.

In addition, under 40 CFR 260.22, a petitioner must prove that the waste does not exhibit any of the hazardous waste characteristics (that is, ignitability, reactivity, corrosivity, and toxicity) and present sufficient information for EPA to decide whether factors other than those for which the waste was listed warrant retaining it as a hazardous waste. (See part 261 and the background documents for the listed waste.)

Generators remain obligated under RCRA to confirm whether their waste remains non-hazardous based on the hazardous waste characteristics, even if EPA has “delisted” the waste.

Besides considering the criteria in 40 CFR 260.22(a) and § 3001(f) of RCRA, 42 U.S.C. 6921(f), and in the background documents for the listed wastes, EPA must consider any factors (including additional constituents) other than those for which EPA listed the waste, if a reasonable basis exists that these additional factors could cause the waste to be hazardous.

EPA must also consider as hazardous waste mixtures containing listed hazardous wastes and wastes derived from treating, storing, or disposing of listed hazardous waste. See § 261.3(a)(2)(iii and iv) and (c)(2)(i), called the “mixture” and “derived-from” rules, respectively. These wastes are also eligible for exclusion and remain hazardous wastes until excluded. See 66 FR 27266 (May 16, 2001).

In June 2017, Blanchard petitioned EPA to exclude from the lists of hazardous wastes contained in §§ 261.31 and 261.32, residual solids (F037) generated during reclamation activities conducted at its GBR facility located in Texas City, Texas. The waste falls under the classification of listed waste pursuant to §§ 261.31 and 261.32. Specifically, in its petition, Blanchard requested that EPA grant a conditional exclusion for the annual generation volume of 20,000 cubic yards of F037 residual solids.

Blanchard owns and operates the GBR facility, located in Texas City, Galveston County, Texas. Blanchard is a wholly-owned subsidiary of Marathon Petroleum Company LP. Blanchard's demonstration evaluated representative samples of its residual solids resulting from the indirect thermal desorption reclamation of OBSMs managed on-site at Blanchard's GBR facility. OBSMs managed on-site at Blanchard's GBR facility result from separate management practices within GBR's petroleum refining operations. Blanchard's approved Sampling and Analysis Plan (SAP) identified three (3) management practices, which result in the generation of three (3) corresponding categories of OBSMs with unique physical properties. The three (3) identified categories of Blanchard's OBSMs include, Category 1, Oil/Water/Solid Separation Sludges (K048 through K052, F037 and F038); Category 2, Crude Oil and Clarified Slurry Oil Sediments (K169 and K170); and Category 3, Stabilized Spent Hydrotreating and Hydrorefining Catalysts (K171 and K172).

Blanchard's demonstration utilized a commercial indirectly-fired thermal desorption unit (“ITDU”) located at US Ecology Texas' (“USET”) permitted commercial facility in Robstown, Texas. Blanchard considered it prudent to utilize USET's ITDU to avoid having to invest the significant capital and resources required to site and construct a full-scale ITDU on-site at Blanchard's GBR facility, prior to receiving an approved delisting determination. The EPA acknowledged Blanchard's use of USET's commercial ITDU to perform its demonstration, under its approved SAP.

USET's commercial ITDU was designed and constructed by TD*X Associates LP (“TD*X”), located in Beaumont, Texas. TD*X currently operates the commercial ITDU on-site at USET's Robstown facility, under contract with USET. USET has extensive experience in the management and processing of Blanchard's OBSMs, and is currently contracted with Blanchard to provide such services at USET's Robstown facility.

Blanchard has entered into a services agreement with US Ecology Thermal Services LLC (“USETS”) to provide and operate an ITDU, on-site at its GBR facility. USETS is the refinery services affiliate of USET. Blanchard's proposed ITDU will be designed, constructed and operated by TD*X, as part of USETS's services agreement with Blanchard. The processing capabilities, efficiencies and capacity of Blanchard's proposed ITDU are comparable to USET's commercial ITDU that was utilized under Blanchard's demonstration.

To support its petition, Blanchard conducted individual sampling events on residual solids resulting from the reclamation of Blanchard's three (3) identified categories of OBSMs. Each separate sampling event consisted of four (4) composite samples taken during a 24-hour period of representative operation. Each composite sample was comprised of individual grab samples (i.e. a minimum of four), obtained during separate six (6) hour periods of the 24-hour sampling event. Compositing of samples and performance of quality control requirements were performed by Blanchard's selected analytical laboratory, TestAmerica Laboratories, Inc. (“TestAmerica”). Blanchard submitted: Historical information on waste generation and management practices; and analytical results from twelve samples for total and TCLP concentrations of constituents of concern (COC)s.

EPA believes that the descriptions of the Blanchard analytical characterization provide a reasonable basis to grant Blanchard's petition for an exclusion of the residual solids. EPA believes the data submitted in support of the petition show the residual solids is non-hazardous. Analytical data for the residual solids samples were used in the DRAS to develop delisting levels. The residual solids from Category 3 can only be delisted if stabilization of the residual solids occur. Data from the stabilized Category 3 residual solids demonstrate the concentrations from the stabilized residuals meet the delisting requirements. The data summaries for COCs are presented in Table I. EPA has reviewed the sampling procedures used by Blanchard and has determined that it satisfies EPA criteria for collecting representative samples of the variations in constituent concentrations in the residual solids. In addition, the data submitted in support of the petition show that COCs in Blanchard's waste are presently below health-based levels used in the delisting decision-making. EPA believes that Blanchard has successfully demonstrated that the residual solids are non-hazardous.

For this delisting determination, EPA used such information gathered to identify plausible exposure routes (i.e. groundwater, surface water, air) for hazardous constituents present in the petitioned waste. EPA determined that disposal in a landfill is the most reasonable, worst-case disposal scenario for Blanchard's petitioned waste. EPA applied the Delisting Risk Assessment Software (DRAS) described in 65 FR 58015 (September 27, 2000) and 65 FR 75637 (December 4, 2000), to predict the maximum allowable concentrations of hazardous constituents that may be released from the petitioned waste after disposal and determined the potential impact of the disposal of Blanchard's petitioned waste on human health and the environment. A copy of this software can be found on the world wide web at f://www.epa.gov/reg5rcra/wptdiv/hazardous/delisting/dras-software.html. In assessing potential risks to groundwater, EPA used the maximum waste volumes and the maximum reported extract concentrations as inputs to the DRAS program to estimate the constituent concentrations in the groundwater at a hypothetical receptor well down gradient from the disposal site. Using the risk level (carcinogenic risk of 10-5 and non-cancer hazard index of 1.0), the DRAS program can back-calculate the acceptable receptor well concentrations (referred to as compliance-point concentrations) using standard risk assessment algorithms and EPA health-based numbers. Using the maximum compliance-point concentrations and EPA's Composite Model for Underflow Water Migration with Transformation Products (EPACMTP) fate and transport modeling factors, the DRAS further back-calculates the maximum permissible waste constituent concentrations not expected to exceed the compliance-point concentrations in groundwater.

EPA believes that the EPACMTP fate and transport model represents a reasonable worst-case scenario for possible groundwater contamination resulting from disposal of the petitioned waste in a surface impoundment, and that a reasonable worst-case scenario is appropriate when evaluating whether a waste should be relieved of the protective management constraints of RCRA Subtitle C. The use of some reasonable worst-case scenarios resulted in conservative values for the compliance-point concentrations and ensures that the waste, once removed from hazardous waste regulation, will not pose a significant threat to human health or the environment.

The DRAS also uses the maximum estimated waste volumes and the maximum reported total concentrations to predict possible risks associated with releases of waste constituents through surface pathways (e.g. volatilization from the impoundment). As in the above groundwater analyses, the DRAS uses the risk level, the health-based data and standard risk assessment and exposure algorithms to predict maximum compliance-point concentrations of waste constituents at a hypothetical point of exposure. Using fate and transport equations, the DRAS uses the maximum compliance-point concentrations and back-calculates the maximum allowable waste constituent concentrations (or “delisting levels”).

In most cases, because a delisted waste is no longer subject to hazardous waste control, EPA is generally unable to predict, and does not presently control, how a petitioner will manage a waste after delisting. Therefore, EPA currently believes that it is inappropriate to consider extensive site-specific factors when applying the fate and transport model. EPA does control the type of unit where the waste is disposed. The waste must be disposed in the type of unit the fate and transport model evaluates.

The DRAS results which calculate the maximum allowable concentration of chemical constituents in the waste are presented in Table I. Based on the comparison of the DRAS and TCLP Analyses results found in Table I, the petitioned waste should be delisted because no COCs tested are likely to be present or formed as reaction products or by-products in Blanchard's waste.

EPA concluded, after reviewing Blanchard's processes, that no other hazardous COCs, other than those for which tested, are likely to be present or formed as reaction products or by-products in the waste. In addition, on the basis of explanations and analytical data provided by Blanchard, pursuant to § 260.22, EPA concludes that the petitioned waste does not exhibit any of the characteristics of ignitability, corrosivity, reactivity or toxicity. See §§ 261.21, 261.22 and 261.23, respectively.

During the evaluation of Blanchard's petition, EPA also considered the potential impact of the petitioned waste via non-groundwater routes (i.e. air emission and surface runoff). With regard to airborne dispersion in particular, EPA believes that exposure to airborne contaminants from Blanchard's petitioned waste is unlikely. Therefore, no appreciable air releases are likely from Blanchard's residual solids under any likely disposal conditions. EPA evaluated the potential hazards resulting from the unlikely scenario of airborne exposure to hazardous constituents released from Blanchard's residual solids in an open landfill. The results of this worst-case analysis indicated that there is no substantial present or potential hazard to human health and the environment from airborne exposure to constituents from Blanchard's residual solids.

The descriptions of Blanchard's hazardous waste process and analytical characterization provide a reasonable basis for EPA to grant the exclusion. The data submitted in support of the petition show that constituents in the waste are below the leachable concentrations (see Table I). EPA believes that Blanchard's residual solids will not impose any threat to human health and the environment.

Thus, EPA believes Blanchard should be granted an exclusion for the residual solids. EPA believes the data submitted in support of the petition show Blanchard's residual solids is non-hazardous. The data submitted in support of the petition show that constituents in Blanchard's waste is presently below the compliance point concentrations used in the delisting decision and would not pose a substantial hazard to the environment. EPA believes that Blanchard has successfully demonstrated that the residual solids sludge is non-hazardous.

EPA therefore, proposes to grant an exclusion to Blanchard for the residual solids described in its petition. EPA's decision to exclude this waste is based on descriptions of the treatment activities associated with the petitioned waste and characterization of the residual solids.

If EPA finalizes the proposed rule, EPA will no longer regulate the petitioned waste under Parts 262 through 268 and the permitting standards of Part 270.

The petitioner, Blanchard, must comply with the requirements in 40 CFR part 261, Appendix IX, Table 1. The text below gives the rationale and details of those requirements.

This paragraph provides the levels of constituents for which Blanchard must test the residual solids, below which these wastes would be considered non-hazardous. EPA selected the set of inorganic and organic constituents specified in Paragraph (1) of 40 CFR part 261, Appendix IX, Table 1, (the exclusion language) based on information in the petition. EPA compiled the inorganic and organic constituents list from the composition of the waste, descriptions of Blanchard's treatment process, previous test data provided for the waste, and the respective health-based levels used in delisting decision-making. These delisting levels correspond to the allowable levels measured in the TCLP concentrations.

The purpose of this paragraph is to ensure that Blanchard manages and disposes of any residual solids that contains hazardous levels of inorganic and organic constituents according to Subtitle C of RCRA. Managing the residual solids as a hazardous waste until the verification testing is performed will protect against improper handling of hazardous material. If EPA determines that the data collected under this paragraph do not support the data provided for in the petition, the exclusion will not cover the petitioned waste. The exclusion is effective upon publication in the Federal Register but the disposal of Blanchard's residual solids as non-hazardous cannot begin until the verification sampling is completed.

Blanchard must complete a rigorous verification testing program on the residual solids to assure that the solids do not exceed the maximum levels specified in Paragraph (1) of the exclusion language. This verification program will occur as residual solids are discharged from Blanchard's reclamation process, prior to containment and disposal. The volume of residual solids generated may not exceed 20,000 cubic yards of sludge material annually. Any volume of residual solids generated in excess of 20,000 cubic yards during any twelve-month period must be disposed as hazardous wastes. If EPA determines that the data collected under this paragraph do not support the data provided for the petition, the exclusion will not cover the generated residual solids. If the data from the verification testing program demonstrate that the residual solids meet the delisting levels, Blanchard may commence disposing of the residual solids as non-hazardous solid waste. Blanchard will notify EPA in writing, if and when it begins and ends disposal of the delisted residual solids.

If Blanchard significantly changes the reclamation process described in its petition or starts any processes that generate(s) the waste that may or could affect the composition or type of waste generated as established under Paragraph (1) (by illustration, but not limitation, changes in equipment or operating conditions of the treatment process), they must notify EPA in writing. Blanchard may no longer handle the residual solids generated from the new process as non-hazardous until they have completed verification testing described in Paragraph (3)(A) and (B).

Blanchard describes an application where it may periodically elect to modify operating conditions under its reclamation process to accommodate the addition of chemical stabilization reagents. The facility also provided data on stabilized materials as part of its petition. In the event Blanchard initiates the inclusion of stabilization during operation of its reclamation process, they may no longer handle the residual solids generated from the modified process as non-hazardous until the residual solids meet the delisting levels set in Paragraph (1) under initial verification testing requirements set in Paragraph (3)(A) and verify that no additional constituents are leaching from the stabilized residual solids. Following completion of modified operation of its reclamation process, Blanchard can resume normal operating conditions and testing requirements under Paragraph (3), which were in place prior to initiating the addition of stabilization.

To provide appropriate documentation that Blanchard's residual solids meet the delisting levels, Blanchard must compile, summarize, and keep delisting records on-site for a minimum of five years. It should keep all analytical data obtained through Paragraph (3) of the exclusion language including quality control information for five years. Paragraph (4) of the exclusion language requires that Blanchard furnish these data upon request for inspection by any employee or representative of EPA or the State of Texas.

If the proposed exclusion is made final, it will apply only to the volume of 20,000 cubic yards of residual solids generated annually at Blanchard's GBR facility after successful verification testing. EPA would require Blanchard to file a new delisting petition for any volume of residual solids generated during any twelve-month period in excess of the 20,000 cubic yards, and manage the excess volume of residual solids as hazardous waste until EPA grants a new exclusion.

When this exclusion becomes final, Blanchard's management of the residual solids covered by this petition would be relieved from Subtitle C jurisdiction, and the residual solids from Blanchard will be disposed of in an authorized, solid waste landfill (e.g. RCRA Subtitle D landfill, commercial/industrial solid waste landfill, etc.).

The purpose of Paragraph (6) of the exclusion language is to require Blanchard to disclose new or different information related to a condition at Blanchard's facility or disposal of the waste, if it is pertinent to the delisting. Blanchard must also use this procedure, if the annual testing fails to meet the levels found in Paragraph (1). This provision will allow EPA to reevaluate the exclusion, if a source provides new or additional information to EPA. EPA will evaluate the information on which EPA based the decision to see if it is still correct, or if circumstances have changed so that the information is no longer correct or would cause EPA to deny the petition, if presented. This provision expressly requires Blanchard to report differing site conditions or assumptions used in the petition, in addition to failure to meet the annual testing conditions within 10 days of discovery. If EPA discovers such information itself or from a third party, it can act on it as appropriate. The language being proposed is similar to those provisions found in RCRA regulations governing no-migration petitions at § 268.6.

EPA believes that it has the authority under RCRA and the Administrative Procedures Act (APA), 5 U.S.C. 551 (1978) et seq., to reopen a delisting decision. EPA may reopen a delisting decision when it receives new information that calls into question the assumptions underlying the delisting.

EPA believes a clear statement of its authority in delisting is merited, in light of EPA's experience. See Reynolds Metals Company at 62 FR 37694 and 62 FR 63458 where the delisted waste leached at greater concentrations in the environment than the concentrations predicted when conducting the TCLP, thus leading EPA to repeal the delisting. If an immediate threat to human health and the environment presents itself, EPA will continue to address these situations on a case-by-case basis. Where necessary, EPA will make a good cause finding to justify emergency rulemaking. See APA § 553(b).

In order to adequately track wastes that have been delisted, EPA is requiring that Blanchard provide a one-time notification to any state regulatory agency through which or to which the delisted waste is being carried. Blanchard must provide this notification sixty (60) days before commencing this activity.

If Blanchard violates the terms and conditions established in the exclusion, EPA will start procedures to withdraw the exclusion. Where there is an immediate threat to human health and the environment, EPA will evaluate the need for enforcement activities on a case-by-case basis. EPA expects Blanchard to conduct the appropriate waste analysis and comply with the criteria explained above in Paragraph (1) of the exclusion.

EPA is requesting public comments on this proposed decision. Submit your comments, identified by Docket ID No. EPA-R06-RCRA-2017-0556, at https://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www2.epa.gov/dockets/commenting-epa-dockets.

You should submit requests for a hearing to Kishor Fruitwala, Section Chief (6MM-RP), Multimedia Division, Environmental Protection Agency (EPA), 1445 Ross Avenue, Suite 1200, Dallas, Texas 75202.

You may review the RCRA regulatory docket for this proposed rule at the Environmental Protection Agency Region 6, 1445 Ross Avenue, Suite 1200, Dallas, Texas 75202. It is available for viewing in EPA Freedom of Information Act Review Room from 9:00 a.m. to 4:00 p.m., Monday through Friday, excluding Federal holidays. Call (214) 665-6444 for appointments. The public may copy material from any regulatory docket at no cost for the first 100 pages, and at fifteen cents per page for additional copies. Docket materials are available either electronically in https://www.regulations.gov and you may also request the electronic files of the docket which do not appear on regulations.gov.

Under Executive Order 12866, “Regulatory Planning and Review” (58 FR 51735, October 4, 1993), this rule is not of general applicability and therefore, is not a regulatory action subject to review by the Office of Management and Budget (OMB). This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) because it applies to a particular facility only. Because this rule is of particular applicability relating to a particular facility, it is not subject to the regulatory flexibility provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), or to sections 202, 204, and 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Because this rule will affect only a particular facility, it will not significantly or uniquely affect small governments, as specified in section 203 of UMRA. Because this rule will affect only a particular facility, this proposed rule does not have federalism implications. It 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, as specified in Executive Order 13132, “Federalism”, (64 FR 43255, August 10, 1999). Thus, Executive Order 13132 does not apply to this rule.

Similarly, because this rule will affect only a particular facility, this proposed rule does not have tribal implications, as specified in Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000). Thus, Executive Order 13175 does not apply to this rule. This rule also is not subject to Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant as defined in Executive Order 12866, and because the Agency does not have reason to believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. The basis for this belief is that the Agency used DRAS, which considers health and safety risks to children, to calculate the maximum allowable concentrations for this rule. This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)), because it is not a significant regulatory action under Executive Order 12866. This rule does not involve technical standards; thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988, “Civil Justice Reform”, (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report which includes a copy of the rule to each House of the Congress and to the Comptroller General of the United States. Section 804 exempts from section 801 the following types of rules: (1) Rules of particular applicability; (2) rules relating to agency management or personnel; and (3) rules of agency organization, procedure, or practice that do not substantially affect the rights or obligations of non-agency parties (5 U.S.C. 804(3)). EPA is not required to submit a rule report regarding today's action under section 801 because this is a rule of particular applicability. Executive Order (EO) 12898 (59 FR 7629, February 16, 1994) establishes Federal executive policy on environmental justice. Its main provision directs Federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.

EPA has determined that this proposed rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment. The Agency's risk assessment did not identify risks from management of this material in an authorized, solid waste landfill (e.g. RCRA Subtitle D landfill, commercial/industrial solid waste landfill, etc.). Therefore, EPA believes that any populations in proximity of the landfills used by this facility should not be adversely affected by common waste management practices for this delisted waste.

For the reasons set forth in the preamble, 40 CFR part 261 is proposed to be amended as follows:

I. Public Participation and Request for Comments

FMCSA encourages you to participate by submitting comments and related materials.

If you submit a comment, please include the docket number for this notice (FMCSA-2017-0297), indicate the specific section of this document to which the comment applies, and provide a reason for suggestions or recommendations. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so the Agency can contact you if it has questions regarding your submission.

To submit your comments online, go to www.regulations.gov and put the docket number, “FMCSA-2017-0297” in the “Keyword” box, and click “Search.” When the new screen appears, click on “Comment Now!” button and type your comment into the text box in the following screen. Choose whether you are submitting your comment as an individual or on behalf of a third party and then submit. If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 81/2 by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the facility, please enclose a stamped, self-addressed postcard or envelope. FMCSA will consider all comments and material received during the comment period and may grant or not grant this application based on your comments.

FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant exemptions from certain parts of the Federal Motor Carrier Safety Regulations (FMCSRs). FMCSA must publish a notice of each exemption request in the Federal Register (49 CFR 381.315(a)). The Agency must provide the public an opportunity to inspect the information relevant to the application, including any safety analyses that have been conducted. The Agency must also provide an opportunity for public comment on the request.

The Agency reviews safety analyses and public comments submitted, and determines whether granting the exemption would likely achieve a level of safety equivalent to, or greater than, the level that would be achieved by the current regulation (49 CFR 381.305). The decision of the Agency must be published in the Federal Register (49 CFR 381.315(b)) with the reasons for denying or granting the application and, if granted, the name of the person or class of persons receiving the exemption, and the regulatory provision from which the exemption is granted. The notice must also specify the effective period and explain the terms and conditions of the exemption. The exemption may be renewed (49 CFR 381.300(b)).

NPPC filed this application for exemption on behalf of itself and the following organizations: American Beekeeping Federation; American Farm Bureau Federation; Livestock Marketing Association; National Aquaculture Association; National Cattleman's Beef Association; North American Meat Institute; and the U.S. Cattlemen's Association.

NPPC requests an exemption for all livestock haulers, which they define as “livestock, poultry, aquaculture, and insect producers, processors and transporters,” from the requirement in 49 CFR part 395 that no later than December 18, 2017, a motor carrier require each of its drivers to use an electronic logging device (ELD) to record the driver's hours-of-service (HOS).

NPPC states that it is seeking this limited exemption from ELDs for livestock haulers because:

(1) Livestock haulers are not, and will not be prepared to meet the December 18, 2017 compliance date;

(2) The current ELD retail marketplace does not clearly support the needs of livestock haulers and questions remain as to whether current ELD devices can accommodate HOS exemptions currently utilized by the livestock industry;

(3) There is a significant lack of education and awareness by livestock haulers and the livestock producers they service regarding the ELD mandate, current exemptions, and the use and operation of ELDs, requiring time for adequate outreach and training to take place; and

(4) Concern over the ELD mandate has exposed incompatibilities between the HOS rules and the livestock industry, and is causing disruption for livestock haulers, increasing already severe driver shortages, and endangering the health and welfare of the millions of animals transported by livestock carriers daily.

NPPC notes that their industry is encountering two problem areas regarding the use of ELDs. First, because the ELD initiative fails to directly address the unique requirements of the livestock industry, those drivers who are aware of the program have had difficulty researching the ELD marketplace and identifying cost-effective solutions that are compatible with livestock hauling. NPPC claims that the vendors in the commercial ELD marketplace lack an understanding of the unique needs of the livestock industry and essential design features for their products. Second, nationwide, the average age of American truck drivers is 49. For livestock haulers, the age is likely significantly higher. As a result, these drivers are less familiar with the use of new technology and require more time to train on ELD use. Forcing these drivers to comply with the ELD mandate without appropriate training unfairly discriminates against older drivers who are otherwise more experienced and qualified to haul livestock.

NPPC claims that granting this exemption for the extremely limited segment of the overall transportation economy engaged in the shipment of livestock, will achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent an exemption.

In their application, NPPC explains that livestock haulers are responsible for the daily transportation of millions of animals. They state that the welfare and safety of the animals in transit, together with the safety of other drivers on the road, are the industry's top priorities. NPPC advises that most livestock haulers have participated in additional specialized training, including the pork industry's Transport Quality Assurance (TQA) program and the beef industry's Master Castle Transporter (MCT) program, which provide instruction on proper animal handling and transportation methods. These voluntary education programs were developed by and are offered through the U.S. Department of Agriculture.

The pork industry's TQA program is designed to address the driver safety and animal welfare needs of the approximately 600,000 pigs transported every day on U.S. roads. While the program is voluntary, most major packers require that any driver arriving on their property be TQA-certified. The beef industry's MCT training program was designed by cattle experts and volunteers to educate haulers about low-stress safe handling and transportation methods for cattle. According to the MCT training program, proper handling and transport of cattle reduces sickness, prevents bruising, and improves the quality of the meat. These drivers also transport live fish, which requires a driver to focus on road safety, equipment maintenance, fish health, and water quality. Moving live fish by truck also requires specialized equipment, species-specific loading, and on-time delivery.

NPPC states that the emphasis these programs place on animal welfare benefits driver safety, as it encourages livestock haulers to slow down, be more aware of their surroundings and road conditions, and avoid rough-road situations that could result in animal injury. In addition to general highway safety and accident prevention measures, these programs also focus on the primary underlying goal of the HOS rule—addressing fatigue. For example, the pork industry's TQA program educates haulers about driver fatigue prevention by stressing adequate rest, appropriate climate conditions in the cab, a healthy diet, and how to recognize the signs of fatigue.

NPPC states that granting a limited exemption from the ELD mandate for livestock haulers will enable FMCSA and the livestock industry to undertake the training and education necessary for livestock haulers to understand ELDs. It will also provide an opportunity for FMCSA to develop livestock-specific solutions to the underlying HOS concerns of the industry.

A copy of NPPC's application for exemption is available for review in the docket for this notice.

Information Requested Public Comments

We will accept written comments and information during this reopened comment period regarding the new information indicating additional streams and springs occupied by the western glacier stonefly (Giersch et al. 2016, entire; Giersch 2017, pers. comm.) as described in this document. We will also accept written comments and information on our proposed rule to list the western glacier stonefly and the meltwater lednian stonefly as threatened species under the Act that was published in the Federal Register on October 4, 2016 (81 FR 68379). We will consider information and recommendations from all interested parties.

In addition, we continue to seek comments on the following topics as requested in our October 4, 2016, proposed rule (81 FR 68379):

(1) The meltwater lednian stonefly and the western glacier stonefly biology, range, and population trends, including:

(a) Biological or ecological requirements of the species, including habitat requirements for feeding, breeding, and sheltering;

(b) Genetics and taxonomy;

(c) Historical and current range, including distribution patterns;

(d) Historical and current population levels, and current and projected trends; and

(e) Past and ongoing conservation measures for the species, their habitat, or both.

(2) Factors that may affect the continued existence of the species, which may include habitat modification or destruction, overutilization, disease, predation, the inadequacy of existing regulatory mechanisms, or other natural or manmade factors.

(3) Biological, commercial trade, or other relevant data concerning any threats (or lack thereof) to these species and existing regulations that may be addressing those threats.

(4) Additional information concerning the historical and current status, range, distribution, and population size of these species, including the locations of any additional populations.

If you submitted comments or information on the proposed rule (81 FR 68379) during the initial comment period from October 4, 2016, to December 5, 2016, please do not resubmit them. Any such comments are incorporated as part of the public record of this rulemaking proceeding, and we will fully consider them in the preparation of our final determination. Our final determination will take into consideration all written comments and any additional information we receive during all comment periods. The final decision may differ from the proposed rule, based on our review of all information received during this rulemaking proceeding.

Please include sufficient information with your submission (such as scientific journal articles or other publications) to allow us to verify any scientific or commercial information you include. Please note that submissions merely stating support for or opposition to the action under consideration without providing supporting information, although noted, will not be considered in making a determination, as section 4(b)(1)(A) of the Act directs that determinations as to whether any species is an endangered or a threatened species must be made “solely on the basis of the best scientific and commercial data available.”

You may submit your comments and materials concerning the proposed rule by one of the methods listed in ADDRESSES. We request that you send comments only by the methods described in ADDRESSES.

If you submit information via http://www.regulations.gov, your entire submission—including any personal identifying information—will be posted on the Web site. If your submission is made via a hardcopy that includes personal identifying information, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so. We will post all hardcopy submissions on http://www.regulations.gov.

Comments and materials we receive, as well as supporting documentation we used in preparing the proposed rule, will be available for public inspection on http://www.regulations.gov, or by appointment, during normal business hours, at the U.S. Fish and Wildlife Service, Montana Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT).

In accordance with our joint policy on peer review published in the Federal Register on July 1, 1994 (59 FR 34270), we sought the expert opinions of six appropriate and independent specialists regarding the proposed rule, including the new information discussed in this document, and received comments or peer reviews from four peer reviewers. The purpose of peer review is to ensure that our listing determinations are based on scientifically sound data, assumptions, and analyses. The peer reviewers have expertise in stonefly biology, habitat, and life history.

On October 4, 2016, we published a 12-month finding for the western glacier stonefly and a proposed rule to list the western glacier stonefly and meltwater lednian stonefly as threatened species under the Act (81 FR 68379). We combined the 12-month finding and proposed rule in one document for efficiency. Please refer to that proposed rule for information about western glacier stonefly and meltwater lednian stonefly taxonomy, descriptions of the two species, distribution and abundance, habitat, and biology, as well as a detailed description of previous Federal actions concerning the western glacier stonefly and meltwater lednian stonefly prior to October 4, 2016. As discussed in our proposed rule, we became aware of information in August 2016 indicating additional streams and springs occupied by western glacier stonefly in southwestern Montana and northwestern Wyoming. Furthermore, in March 2017, we became aware of additional information on western glacier stonefly, indicating a larger range than previously known. This new information from August 2016 and March 2017 is described below.

We received updated information on the distribution of western glacier stonefly from the United States Geological Survey (USGS) on August 22, 2016. This information was included in a final report to the Service examining the status, distribution, and ecology of the meltwater lednian stonefly and the western glacier stonefly (Giersch et al. 2016, entire). In this report, USGS documented western glacier stonefly approximately 500 miles farther south than previously known (Giersch et al. 2016, p. 28). These southern streams and springs were in the Absaroka-Beartooth Wilderness in southern Montana and in Grand Teton National Park in northwestern Wyoming. On March 22, 2017, we again received updated information on the distribution of western glacier stonefly from the USGS. This information was from field surveys conducted in late 2016. These surveys identified additional occupied streams and springs of western glacier stonefly in southern Montana and northwestern Wyoming (in the Absaroka-Beartooth Wilderness and Grand Teton National Park; Figure 1).

In addition, a study funded by the Wyoming Natural Diversity Database estimated the degree to which western glacier stonefly were genetically different amongst the three mountain ranges (Glacier National Park, Absaroka-Beartooth Wilderness, and Grand Teton National Park) (Hotaling et al. 2017, p. 11). Although the study noted that there is evidence of significant genetic differentiation amongst western glacier stonefly populations residing in the different mountain ranges, the authors do not believe the evidence supports multiple species designations (Hotaling et al. 2017, p. 12). As a result of the additional range information and genetics report, we are now aware of a total of 16 occupied streams or springs of western glacier stonefly rangewide (Montana and Wyoming).

Under the authority of Chapter 537 of Title 46 of the United States Code, 46 U.S.C. 53701, et seq., the FFP may provide long-term financing to the commercial fishing and aquaculture industries for fishing vessels, fisheries facilities, aquaculture facilities, and certain designated individual fishing quota (IFQs). Section 302 of the Coast Guard Authorization Act of 2015 (Pub. L. 114-120) amended Chapter 537, providing the FFP with the authority to finance the purchase of harvesting rights in a fishery that is federally managed under a limited access system. This amendment is codified at 46 U.S.C. 53702(b)(4)(B). This action would modify the existing Program regulations to reflect this statutory change. The net effect of this change will be to provide additional authority for the program to lend, while leaving the original IFQ authority to Fishery Management Councils (FMCs) to use as needed.

46 U.S.C. 53706 authorizes the FFP to finance or refinance the purchase of individual fishing quotas in accordance with section 303(d)(4) of the Magnuson-Stevens Fishery Conservation and Management Act (MSA), now codified at 16 U.S.C. 1853a(g). Under this provision of the MSA, an FMC may submit, and NMFS may approve and implement, a loan program to aid in (1) the acquisition of IFQ by fishermen who fish from “small vessels,” and (2) the first time purchase of IFQ by “entry level fishermen.” Therefore, under this authority, the FFP cannot initiate or implement a lending program to finance or refinance the purchase of IFQ until the appropriate FMC submits a request to NMFS and provides guidance for the requisite criteria.

NMFS currently administers two loan programs pursuant to the existing IFQ authority: The Northwest Halibut/Sablefish and Bering Sea and Aleutian Islands Crab IFQ loan programs. NMFS anticipates no effects to either of these existing loan programs as a result of this proposed action.

The new authority provided by Public Law 114-120 broadens the FFP's existing authority, and authorizes the Program to finance the purchase of harvesting rights in a fishery that is federally managed under a limited access system. NMFS will interpret “limited access system” in accordance with section 3(27) of the MSA for purposes of this authority. The MSA defines “limited access system” as “a system that limits participation in a fishery to those satisfying certain eligibility criteria or requirements contained in a fishery management plan or associated regulation.” 16 U.S.C. 1802(27). Such definition includes, but is not limited to, IFQ fisheries.

The new authority provided by Public Law 114-120 does not require FMCs to initiate a request to establish a loan program in a fishery that is federally managed under a limited access system in order for the FFP to provide financing in such a fishery. However, under the MSA, FMCs are primarily responsible for developing fishery management plans (FMPs) for fisheries within their authority that require conservation and management. It is possible that the availability of fisheries loans may have unanticipated effects on the achievement of FMP goals and objectives. Therefore, NMFS believes it appropriate to allow the FMCs to comment on the potential or actual effect of a loan program for harvesting rights in fisheries under their authority. An FMC may provide an explanation to NMFS at any time, in writing, why the potential or continuing availability of financing for harvesting rights in a fishery under its authority would harm the achievement of the goals and objectives of the FMP applicable to the fishery. If NMFS accepts the Council's reasoning, harvesting rights loans would not be provided, or would cease to be provided, in that fishery. In such a scenario, NMFS would publish a notice in the Federal Register notifying the public that new loans will not be made in that fishery. If there were already loan applications under consideration, the exceptional circumstances would justify NMFS returning any loan fees submitted with loan applications. The opportunity for FMC input will help ensure that loans made by the FFP do not undermine or conflict with the goals and objectives of specific FMPs.

Section 302 of the Coast Guard Authorization Act of 2015 imposes no limitations on the extent of financing to be provided by the FFP for the purchase of harvesting rights. However, it does reserve $59 million of direct loan authority for historical uses, defined at 46 U.S.C. 53701(8). Thus, NMFS anticipates that the balance of annual direct loan authority—currently $41 million—may be available to finance or refinance the purchase of harvesting rights in federally managed fisheries under a limited access system. This action will allow NMFS to fully use the program's loan authority either for historical purposes or any authorized new purposes should it be determined that demand or lack of demand in either area would result in unused loan authority.

Lending for harvesting rights would follow existing FFP lending procedures and guidelines. Borrowers must be U.S. citizens or entities eligible to document a vessel for coastwise trade under 46 U.S.C. 50501, meet all general FFP requirements, and meet all requirements to hold the harvesting rights under the applicable FMP at the time of loan closing. The FFP may require additional lending conditions and security terms such as loan guarantees or security interests in other collateral to bring credit risk to acceptable levels. Affiliated businesses, the borrower's principals or majority shareholders, persons or entities with a financial interest in the borrower, or any individuals holding community property rights may also be required to provide a guaranty.

In addition, all loan applicants are subject to background and credit investigations, which may include, but are not limited to, reviews for unresolved fishing violations, criminal background checks, delinquent debt investigations, and credit reports. Like other FFP loan programs, lending for harvesting rights is subject to a statutory loan limit of up to 80 percent of the actual cost of the transaction, set as the purchase price or, in the case of refinancing, the current market value. The FFP retains sole discretion to determine the transaction's actual cost or current market value.

Harvesting rights loan amounts can carry up to a 25-year term and can be used to either purchase new rights or refinance the debt associated with the prior purchase(s) of harvesting rights. In addition to maintaining a 20 percent minimum equity stake, borrowers refinancing existing debt will only receive the lesser of the outstanding amount of debt to be refinanced or 80 percent of the current market value of the harvesting right.

If a borrower seeking refinancing fails to have the requisite 20 percent equity stake (measured as the difference between the current market value of the primary collateral and the amount of the loan), that borrower will need to pay down debt to meet the required level. In addition, under FFP standards, borrowers are only eligible for refinancing if their initial purchase would have been eligible for financing. The program will refinance harvesting rights acquired prior to this regulation if the buyer's original purchase would have been eligible for FFP financing under the terms of this action.

Prospective borrowers may apply for a loan through any of the NOAA Fisheries Service regional FFP offices (St. Petersburg, FL; Gloucester, MA; Seattle, WA). They must pay the appropriate application fee, set by 46 U.S.C. 53713(b) as one-half of one percent of the loan amount requested, which is made up of two parts. Half is the “filing fee,” and is nonrefundable when the FFP officially accepts the application. The other half, known as the “commitment fee,” becomes nonrefundable when the FFP executes and mails an Approval-in-Principle (AIP) letter to the applicant. The FFP may refund the commitment fee if the FFP declines the application or the application is withdrawn prior to the issuance of an AIP letter.

This proposed action would add the following section, as explained here.

This new section provides regulatory provisions specific to the harvesting rights loans. At the time a borrower submits an application, he or she must satisfy the criteria listed in this new section in order to be eligible to receive financing under the program. The borrower must comply with any limitations on the quantity of harvesting rights that may be owned by one holder, as specified in the applicable FMP and implementing regulations. The FFP will not finance harvesting rights in excess of ownership limitations.

This proposed rule is published under the authority of, and is consistent with, Chapter 537 of Title 46 of the United States Code and the Magnuson-Stevens Act, as amended. The NMFS Assistant Administrator has determined that this proposed rule is consistent with Chapter 537 of Title 46 of the U.S. Code, the Magnuson-Stevens Act, as amended, and other applicable law, subject to further consideration after public comment.

In addition to public comment about the proposed rule's substance, NMFS also seeks public comment on any ambiguity or unnecessary complexity from the language used in this proposed rule.

NMFS has preliminarily determined that this rule qualifies to be categorically excluded from further NEPA review. This action is consistent with categories of activities identified in CE G7 of the Companion Manual for NOAA Administrative Order 216-6A, and we have not identified any extraordinary circumstances that would preclude this categorical exclusion. NMFS is accepting comments and information during the public comment period for the proposed rule relevant to our preliminary categorical exclusion determination.

This proposed rule has been determined to be not significant for purposes of Executive Order 12866.

This proposed rule does not duplicate, overlap, or conflict with any other relevant Federal rules.

Notwithstanding any other provision of the law, no person is required to respond to, and no person shall be subject to penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number.

This proposed rule contains collections-of-information subject to the PRA, which have been approved by OMB under control number 0648-0012. The application requirements contained in these rules have been approved under OMB control number 0648-0012. Public reporting burden for placing an application for FFP financing is estimated to average eight hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

Send comments regarding this burden estimate, or any other aspect of this data collection, including suggestions for reducing the burden, to NMFS (see ADDRESSES) and by email to [email protected] or fax to (202) 395-7285.

The Chief Counsel for Regulation of the Department of Commerce has certified to the Chief Counsel for Advocacy of the Small Business Administration (SBA) that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities.

The Regulatory Flexibility Act (RFA), 5 U.S.C. 601, et seq., requires that, “[w]henever an agency is required by section 553 of this title [5 USCS § 553], or any other law, to publish general notice of proposed rulemaking for any proposed rule, or publishes a notice of proposed rulemaking for an interpretative rule involving the internal revenue laws of the United States, the agency shall prepare and make available for public comment an initial regulatory flexibility analysis. Such analysis shall describe the impact of the proposed rule on small entities.” 5 U.S.C. 603(a). However, where an agency can certify “that the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities” then an agency need not undertake a full regulatory flexibility analysis. 5 U.S.C. 605(b).

Participation in the FFP is entirely voluntary. This action imposes no mandatory requirements on any business. Once final, this proposed rule will implement programs authorized by law. Specifically, these rules enact regulatory additions to create a new lending purpose authorized by Section 302 of the Coast Guard Authorization Act of 2015 (Pub. L. 114-120) and will be implemented in accordance with 50 CFR part 253, subpart B. This action will create new § 253.31.

As defined by NMFS for RFA purposes, this rule may affect small fishing entities that have annual revenues of $11.0 million or less, including, but not limited to, vessel owners, vessel operators, individual fishermen, small corporations, and others engaged in commercial fishing activities regulated by NOAA. Borrowers under this authority may also include large businesses. Notably, because the FFP is a voluntary program that provides loans to qualified borrowers, non-borrowers—large or small—would not be regulated by this rule.

Although the FFP requires certain supporting documentation during the life of a loan, the requirements do not impose unusual burdens when compared to the burdens imposed by other lenders. Moreover, because the basic need for financing would continue to exist without the FFP, the individuals seeking financing would still need to comply with similar, if not identical, requirements imposed by another lender. Records required to participate in the FFP are usually within the normal records already maintained by fishermen. It should take fewer than eight hours per application to meet these requirements.

The information required from borrowers, such as income tax returns, insurance policies, permits, licenses, etc., is already available to them. Depending on circumstances, the FFP may require other supporting documents, including financial statements, property descriptions, and other documents that can be acquired at reasonable cost if they are not already available.

FFP lending is a source of long-term, fixed rate capital financing and imposes no regulatory requirements on anyone other than those applying for loans. FFP borrowers make a voluntary decision to use the available lending.

These loan programs will only have positive impacts on borrowers. Because participation is voluntary and requires effort and the outlay of an application fee, borrowers for harvesting rights financing are assumed to have made a determination that using FFP financing provides a benefit, such that the FFP's long-term, fixed rate financing provides only a positive economic impact. Importantly, the FFP does not regulate or manage the affairs of its borrowers, and the regulations impose no additional compliance, operating or other fees or costs on small entities other than a financing relationship would require.

As a result of this certification, an initial regulatory flexibility analysis is not required and none has been prepared.

For the reasons set forth in the preamble, NMFS proposes to amend 50 CFR part 253, subpart B, as follows:

The HMS FMP was prepared by the Council and is implemented under the authority of the MSA by regulations at 50 CFR part 660. Although it adopted all conservation and management measures in place under various Federal statutes (e.g., the Marine Mammal Protection Act and the Endangered Species Act) and state regulations, the HMS FMP did not incorporate the LE DGN permit programs of California and Oregon. Currently, the large-mesh DGN fishery (14” minimum mesh size) is Federally managed under the HMS FMP and via regulations of the states of California and Oregon to conserve target and non-target stocks, including protected species that are incidentally captured. (California has an active LE DGN program, Oregon no longer issues DGN permits, and DGN fishing is prohibited in Washington.)

Since 2014, the Council has considered transitioning California's LE DGN permit program from state to MSA authority. On March 12, 2017, the Council adopted a final preferred alternative that would amend the HMS FMP and transition the State of California LE DGN permit program from state management to Federal management under MSA authority and entitle all fishermen authorized to fish with large-mesh DGN gear under state law to be eligible to receive a Federal LE DGN permit. As of August 31, 2017, 70 California LE DGN permits were issued for the 2016-2017 fishing season, and 67 have been renewed for the 2017-2018 fishing season. The average number of active DGN vessels per year from 2010 through 2016 is 20 vessels. The action would neither increase capacity within the DGN fishery, nor would it incentivize or stimulate fishing effort or activity of current latent permits. After the initial issuance of Federal DGN permits, no additional permits would be issued, and permits that are not renewed in future years would permanently expire. NMFS would not reissue the expired permits.

In order to participate in the DGN fishery, current participants must possess a State of California LE DGN permit, a California commercial fishing license, a California general gill/trammel net permit, and a California swordfish permit. Additionally, the vessel that the participant fishes from must have a Federal Pacific Highly Migratory Species (HMS) permit with a DGN gear endorsement. After the LE DGN permit transitions from the State of California to Federal management, each participant will need to hold all the same permits and licenses, except that the Federal LE DGN permit will take the place of the State of California LE DGN permit. Although these permits and licenses would be required to fish, possession of a current and up-to-date State of California LE DGN permit is the only permit required to initially obtain a Federal LE DGN permit.

This proposed rule would adopt many of the current State of California management measures associated with the fishery. For example, NMFS would adopt current California requirements regarding the assignment of a permit (i.e., permits would be issued to an individual and assigned to a specific vessel), the transfer of permits between permit holders (i.e., a permit must be held for three years before it is eligible to be transferred), and an annual renewal cycle.

Upon the date of publication of the final rule, all 70 state-eligible permit holders would be eligible to receive a Federal DGN permit if they have renewed their state DGN permit by March 31, 2018. Permit holders who fail to renew their state DGN permit by March 31, 2018, will not be eligible for a Federal DGN permit. As of August 31, 2017, 67 permit holders have renewed their state LE DGN permit. If a state LE DGN permit is transferred after publication of the proposed rule, the transferee, but not the transferor, would be eligible to receive a Federal LE DGN permit upon publication of the final rule.

Federal LE DGN permits would be issued annually for the fishing year starting April 1 and ending March 31 of the following year. Permits would expire on March 31 of each year and, after initial issuance (expected in 2018), the permit renewal deadline would be April 30 of each fishing year. A completed DGN permit renewal form must be received by NMFS no later than close-of-business April 30. Any renewal form received after that date would result in the permanent expiration of the Federal DGN permit. A permit owner who fails to submit a renewal form by the deadline may submit a renewal form to NMFS with a written statement that the failure to renew the permit by the deadline was proximately caused by the permit owner's illness or injury. When a permit owner has died, the owner's estate or other personal representative may submit a statement explaining that the permit owner's death has prevented a timely renewal. The permit holder, or in the case of a deceased permit owner, the estate or other personal representative, will need to provide written proof of illness, injury or death. NMFS will not consider any such renewal request made after July 31. A permit holder would need to hold a Federal LE DGN permit for a vesting period of at least three years before it would be eligible to be transferred. This vesting period would extend across both state and Federal permit programs (i.e., if a permit holder held a state LE DGN permit for two years and a Federal LE DGN permit for one year, the permit may be transferred).

This proposed rule also includes technical edits to existing regulatory text. These edits add the word “general” before instances of “HMS permit” to distinguish the existing HMS permit from the new LE DGN permit; update a web address from which permit applications may be obtained; update the reference to the NMFS “Southwest Region” to refer to the West Coast Region, into which it was incorporated; and update the description of the NMFS regional “Sustainable Fisheries Division” to describe it as part of the West Coast Region.

Pursuant to section 304 (b)(1)(A) of the MSA, the NMFS West Coast Regional Administrator has determined that this proposed rule is consistent with the HMS FMP, other provisions of the MSA, and other applicable law, subject to further consideration after public comment.

This proposed rule has been determined to be not significant for purposes of Executive Order 12866. This proposed rule is not an Executive Order 13771 regulatory action because this proposed rule is not significant under Executive Order 12866.

This proposed rule contains a collection-of-information requirement subject to the Paperwork Reduction Act (PRA) and which has been approved by OMB under control number 0648-0204. Public reporting burden for the additional collection of information is estimated to average thirty minutes per form, including time for reviewing instructions, gathering the information needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate, or any other aspect of this data collection, including suggestions for reducing the burden, to NMFS (see ADDRESSES) and by email to [email protected], or fax to (202) 395-5806.

Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number. All currently approved NOAA collections of information may be viewed at: http://www.cio.noaa.gov/services_programs/prasubs.html.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities. The proposed rule is administrative in nature and adopts current State of California permit requirements as they relate to the DGN fishery. This action is not expected to increase capacity, incentivize or stimulate fishing effort or activity of current latent permits, or change current fishing practices.

For Regulatory Flexibility Act (RFA) purposes only, NMFS has established a small business size standard for businesses, including their affiliates, whose primarily industry is commercial fishing (50 CFR 200.2). A business primarily involved in commercial fishing (NAICS 11411) is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including its affiliates), and its combined annual receipts are not in excess of $11 million for all of its affiliated operations worldwide. NMFS has determined that all current participants in the DGN fishery are small entities under the NMFS standard. The average ex-vessel revenue for the U.S. West Coast DGN fishery from 2011 to 2015 is $745,600, with an average of 20 vessels participating per year. Therefore, the average ex-vessel revenue per active participant is $37,280. The increase in administrative costs, if any, resulting from this action would be less than 1% of ex-vessel revenues per active participant. In addition, because each affected entity is a small business, there would be no disproportionate economic impacts between large and small entities.

Currently, participants must possess a Federal Pacific Highly Migratory Species (HMS) permit ($30), as well as a State of California commercial fishing license ($136.99), a California general gill/trammel net permit ($469.25), and a California LE DGN permit ($469.25) that includes a swordfish permit for fishing with hook-and-line or harpoon. If a fisherman does not participate in the DGN fishery, but participates in the harpoon or hook-and-line fishery, they must purchase a swordfish permit for $469.25. If this action is implemented, fishermen would receive a Federal LE DGN permit. The fee for a Federal LE DGN permit would be determined by only the administrative cost of issuing the permit, and it is expected that the Federal LE DGN permit would cost less than $100, which is far less than the California LE DGN permit cost of $469.25. There are three likely scenarios associated with implementing a Federal LE DGN permit, discussed below; in each scenario, the economic effects are not significant, as they would lead to either a reduction in costs or an insignificant increase in costs.

In the first scenario, fishermen would acquire a Federal LE DGN permit. If the State of California does not amend its regulations and continues to require that fishermen purchase a State of California LE DGN permit (with the swordfish permit included), the cost increase would be only the additional cost of the Federal LE DGN permit. In the second scenario, if fishermen purchase a Federal LE DGN permit and state regulations are amended to no longer require the State of California LE DGN permit, but either a swordfish permit is still required or fishermen continue participating in the harpoon or hook-and-line fishery, there would be a cost increase equal to the cost of the Federal LE DGN permit, while the savings from not purchasing the state LE DGN permit would be offset by the cost of purchasing the swordfish permit. In the third scenario, if fishermen purchase a Federal LE DGN permit, a state LE DGN permit is no longer required, and either a swordfish permit is not required or fishermen do not participate in the harpoon or hook-and-line fishery, the fishermen would realize a cost savings, and the amount of cost savings would equal the difference between the cost of the state LE DGN permit ($469.25) and the cost of the Federal LE DGN permit (expected to be less than $100).

As noted above, all entities subject to this action are considered small entities for RFA purposes. Based on the analysis provided above, the proposed action, if adopted, would not have a significant adverse economic impact on these small business entities. As a result, an initial regulatory flexibility analysis is not required and none has been prepared.

For the reasons set out in the preamble, 50 CFR part 660 is proposed to be amended as follows: