82 FR 20847 - Natural Resources Defense Council et al.; Denial of Food Additive Petition
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 85 (May 4, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 85 (May 4, 2017)
| Page Range | 20847-20859 | |
| FR Document | 2017-08987 |
[Federal Register Volume 82, Number 85 (Thursday, May 4, 2017)] [Proposed Rules] [Pages 20847-20859] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-08987] [[Page 20847]] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 170, 177, and 189 [Docket No. FDA-2015-F-0537] Natural Resources Defense Council et al.; Denial of Food Additive Petition AGENCY: Food and Drug Administration, HHS. ACTION: Notification; denial of petition. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is denying a petition, submitted by the Natural Resources Defense Council, Center for Food Safety, Clean Water Action, Children's Environmental Health Network, Center for Science in the Public Interest, Breast Cancer Fund, Center for Environmental Health, Environmental Working Group, and Improving Kids' Environment, requesting that we revoke the Threshold of Regulation (TOR) exemption No. 2005-006 to no longer exempt from our food additive regulations the use of sodium perchlorate monohydrate as a conductivity enhancer in antistatic agents for use in finished articles in contact with dry foods; issue a new FDA regulation to prohibit the use of perchlorates in antistatic agents for use in food-contact articles; and amend our food additive regulations to no longer provide for the use of potassium perchlorate as an additive in closure-sealing gaskets for food containers. DATES: This notification is effective May 4, 2017; except as to any provisions that may be stayed by the filing of proper objections. See Section VI of this document for information on the filing of objections. Submit either electronic or written objections and requests for a hearing by June 5, 2017. Late, untimely filed objections will not be considered. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of June 5, 2017. Objections received by mail/hand delivery/courier (for written/ paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. ADDRESSES: You may submit either electronic or written objections and requests for a hearing identified by Docket No. FDA-2015-F-0537, by any of the following methods: Electronic Submissions Submit electronic objections in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Objections submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your objection will be made public, you are solely responsible for ensuring that your objection does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information or other information that identifies you in the body of your objection, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the objection as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper objections submitted to the Division of Dockets Management, FDA will post your objection, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2015-F-0537 for ``Natural Resources Defense Council et al.; Denial of Food Additive Petition.'' Received objections, those filed in a timely manner (see DATES), will be placed in the docket, and except for those submitted as ``Confidential Submissions,'' publically viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit an objection with confidential information that you do not wish to be made publicly available, submit your objections only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or objections received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Hui-Chen (Anita) Chang, Center for Food Safety and Applied Nutrition (HFS-275), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740-3835, 240-402- 1161. SUPPLEMENTARY INFORMATION: I. Introduction In a document published in the Federal Register of March 16, 2015 (80 FR 13508), we announced that we filed a food additive petition (FAP 4B4808) (``petition'') submitted by the Natural Resources Defense Council, 1152 15th St. NW., Suite 300, Washington, DC 20005; the Center for Food Safety, 303 Sacramento St., Second Floor, San Francisco, CA 94111; Clean Water Action, 144 I St. NW., Suite 400, Washington, DC 20005; the Center for Science in the Public Interest, 1220 L St. NW., Suite 300, Washington, DC 20005; Children's Environmental Health Network, 110 Maryland Ave. NE., Suite 402, Washington, DC 20002; the Breast Cancer Fund, 1388 Sutter St., Suite 400, San Francisco, CA 94109-5400; the Center for Environmental Health, 2201 Broadway, Suite 302, Oakland, CA 94612; Environmental Working Group, 1436 U St. NW., Suite 100, Washington, [[Page 20848]] DC 20009; and Improving Kids' Environment, 1915 West 18th St., Indianapolis, IN 46202 (collectively, ``petitioners''). In the March 2015 document, we requested comments on the petition under Sec. 189.1(c) (21 CFR 189.1(c)). The petition included submissions dated July 31, 2014, October 15, 2014, and December 5, 2014. The October 15, 2014, submission included a resubmission of the entire July 31, 2014, original petition with the inclusion of some additional information. The December 5, 2014, submission contained additional information to that provided in the October 15, 2014, submission. Any references to specific parts of the petition are to the October 15, 2014, submission while specific references to the December 5, 2014, submission will refer to the date of that document. The petition asked FDA to take three separate regulatory actions: (1) Revoke its 2005 approval of TOR exemption No. 2005-006 allowing as much as 1.2 percent sodium perchlorate monohydrate in dry food packaging; (2) issue a new Sec. 189.301 (21 CFR 189.301) prohibiting the use of perchlorate as a conductivity enhancer in the manufacture of antistatic agents to be used in food contact articles; and (3) remove potassium perchlorate as an allowed additive in sealing gaskets for food containers in existing Sec. 177.1210 (21 CFR 177.1210). For accuracy, we will refer to the petition's second request as a request to issue a new regulation under part 189 because a regulation already exists at Sec. 189.301. The petition asserted that the allowed food- contact uses of perchlorate are not safe because there is no longer a reasonable certainty that the perchlorate is not harmful under the intended conditions of use considering: (1) The probable consumption of perchlorate; (2) the cumulative effect of perchlorate after taking into account pharmacologically-related substances, such as thiocyanate and nitrate, in the diet; and (3) additional safety factors necessary to protect the developing brain of fetuses and infants from irreversible harm. The petition also asserted that new exposure data are available that support the requested revocation of TOR exemption No. 2005-006. Both food contact substances that are the subject of the petition-- sodium perchlorate monohydrate and potassium perchlorate--belong to a class of chemicals termed ``perchlorates.'' Perchlorates are both naturally-occurring and man-made chemicals with a wide variety of industrial and some medical applications. Perchlorates are ionic salts that contain the perchlorate anion (chemical structure ClO 4 -). In this notification, the term ``perchlorates'' refers to the class of chemicals while the term ``perchlorate'' refers to the perchlorate ion. II. Background A. Statutory and Regulatory Background The petition asked FDA to take actions related to three different types of FDA regulations. 1. Food Additive Regulation The Federal Food, Drug, and Cosmetic Act (the FD&C Act) authorizes us to regulate ``food additives'' (see section 409(a) of the FD&C Act (21 U.S.C. 348(a)). The FD&C Act defines ``food additive,'' in relevant part, as any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component of food (see section 201(s) of the FD&C Act (21 U.S.C. 321(s))). Food additives can include both substances added directly to food and ``food contact substance[s]'' (i.e., substances intended for use in materials that come into contact with food, for instance in food packaging or manufacturing, but which are not intended to have any technical effect in the food (see Sec. 170.3(e)(3) (21 CFR 170.3(e)(3))). Food additives are deemed unsafe and prohibited except to the extent that we approve their use (see, e.g., section 301(a) and (k) (21 U.S.C. 331(a) and (k)) and 409(a) of the FD&C Act). The FD&C Act provides a process through which persons who wish to use a food additive may submit a petition proposing the issuance of a regulation prescribing the conditions under which the additive may be safely used (see section 409(b)(1) of the FD&C Act). Such a petition is referred to as a ``food additive petition.'' When we conclude that a proposed use of a food additive is safe, we issue a regulation called a ``food additive regulation'' authorizing a specific use of the substance. The specific food additive regulation at issue in the petition, Sec. 177.1210, lists substances allowed as indirect additives (also called food contact substances) in closures with sealing gaskets for food containers. Potassium perchlorate is one of the listed substances authorized for this use under Sec. 177.1210. The FD&C Act provides that we must by regulation prescribe the procedure by which a food additive regulation may be amended or repealed (see section 409(i) of the FD&C Act). Our regulation specific to the administrative actions for food additives provides that the Commissioner of Food and Drugs (the Commissioner), on his own initiative or on the petition of any interested person, may propose the issuance of a regulation amending or repealing a regulation pertaining to a food additive (see Sec. 171.130(a) (21 CFR 171.130(a))). Our regulation, at Sec. 171.130(b), further provides that any such petition must include an assertion of facts, supported by data, showing that new information exists with respect to the food additive or that new uses have been developed or old uses abandoned, that new data are available as to toxicity of the chemical, or that experience with the existing regulation or exemption may justify its amendment or repeal. FDA has issued administrative regulations for food additive petitions in part 171. These regulations apply to food additive petitions requesting either that we authorize the new use of a food additive or that we amend or repeal an existing food additive regulation. 2. TOR Exemption The food additive petition process generally applies to substances used in food packaging or processing when the proposed use will cause the substance to become part of the food at a level that exceeds a minimum ``threshold of regulation'' (see Sec. 170.39 (21 CFR 170.39)). Our determination that a use of a substance is at or below the ``threshold of regulation'' is referred to as a ``threshold of regulation'' exemption, or a TOR exemption. Regardless of whether the use of a substance is at or below the threshold of regulation, we reserve the right to apply the food additive petition process in those cases in which available information establishes that the proposed food-contact use may pose a public health risk (see Sec. 170.39(b)). We established the procedures set forth in Sec. 170.39 to exempt certain substances used in food-contact articles (e.g., food-packaging (such as a cereal bag) or food-processing equipment) that migrate or may be expected to migrate into food at negligible levels from regulation as a food additive. Eligible substances must become a component of food at levels that are at or below the threshold of regulation, must not have been shown to cause cancer in humans or animals or be suspected carcinogens, and must meet other criteria in Sec. 170.39. If we determine the criteria are met, we inform the requestor by letter that the intended use of a substance in food- contact articles is exempt from regulation as a food additive. Therefore, when we issue a TOR exemption, the intended use of the substance does not require a regulation authorizing its food [[Page 20849]] additive use under section 409 of the FD&C Act (also referred to as a ``listing regulation'') or food additive petition (see Sec. Sec. 170.3(e)(2) and 171.8). We issued TOR exemption No. 2005-006 in 2005. We maintain a list of TOR exemptions on our Web site (Ref. 1). Our regulations provide that if we receive significant new information that raises questions about the dietary concentration or the safety of a substance that is the subject of a TOR exemption, we may reevaluate the substance (see Sec. 170.39(g)). Our regulations, at Sec. 170.39(g), state that if we tentatively conclude that the available information no longer supports an exemption for the use of the food-contact material from the food additive regulations, we will notify any persons that requested an exemption for the substance of our tentative decision and will provide them with an opportunity to show why the use of the substance should not be regulated under the food additive provisions of the FD&C Act. If the requestors fail to adequately respond to the new evidence, we notify them that further use of the substance in question for the particular use will require a food additive regulation (see Sec. 170.39(g)). Thus, anyone who seeks to use such substance as a food additive would need to submit a food additive petition seeking such a regulation or obtain authorization through a food contact notification. We also notify other manufacturers, by means of a notice published in the Federal Register, of our decision to revoke a TOR exemption issued for a specific use of a substance in a food-contact article (see Sec. 170.39(g)). 3. Regulation Under Part 189 Our regulations at Sec. 189.1(a) provide that ``food ingredients'' may be prohibited from uses in human food based on a determination that the food ingredients present a potential risk to the public health or have not been shown by adequate scientific data to be safe for use in human food. Additionally, Sec. 189.1(c) provides that the Commissioner, either on his own initiative or on the petition of any interested person, may publish a proposal to establish, amend, or repeal a regulation under this section on the basis of new scientific evaluation or information. We established part 189 to: (1) Provide, for reference purposes, a partial listing of substances prohibited from use in human food and (2) create an administrative process through which we can prohibit by rulemaking the use of substances in human foods because of a determination that they present a potential risk to the public health or have not been shown by adequate scientific data to be safe for use in human foods (see 39 FR 34172, September 23, 1974). B. Abandonment of Use of Potassium Perchlorate Authorized Under 21 CFR Sec. 177.1210 In a document published in the Federal Register on June 30, 2016 (81 FR 42585), we announced that we filed a food additive petition (FAP 6B4816) (``abandonment petition'') that proposed that we amend Sec. 177.1210 to no longer provide for the use of potassium perchlorate as an additive in closure-sealing gaskets for food containers because the use has been intentionally and permanently abandoned. Elsewhere in this issue of the Federal Register, we have published a final rule concluding that the use of potassium perchlorate authorized under Sec. 177.1210 has been permanently and completely abandoned. The final rule amends Sec. 177.1210 to no longer authorize the use of potassium perchlorate as an additive in closure-sealing gaskets for food containers. Because the final rule issued in response to the abandonment petition removes potassium perchlorate as an allowed additive in sealing gaskets for food containers--thereby taking the third action requested in the petition--the petition's third request is moot, and it is neither necessary nor an efficient use of our resources to address the petitioners' assertions regarding the safety of the food additive use of potassium perchlorate that is no longer authorized. Where helpful for clarity, this notification will describe the petition's arguments regarding the food additive use of potassium perchlorate in the course of reviewing the petition's requests to revoke TOR exemption No. 2005-006 and to issue a new regulation under part 189. C. The Scope of a Food Additive Petition The petitioners designated their petition as a ``food additive petition.'' A food additive petition must either propose the issuance of a regulation prescribing the conditions under which a food additive may be safely used (see section 409(b)(1) of the FD&C Act), or propose the amendment or repeal of an existing food additive regulation (see section 409(i) of the FD&C Act). Only one of the petition's requested actions falls within the statutory scope of a food additive petition: Amending Sec. 177.1210 to remove potassium perchlorate as an allowed additive in sealing gaskets for food containers, the action we are taking in response to the abandonment petition. Because the petition's other two requests--the revocation of TOR exemption No. 2005-006 and the issuance of a regulation under part 189 prohibiting the use of perchlorate in the manufacture of antistatic agents to be used in food-contact articles-- are not directed at regulations issued under the food additive petition process, they are governed by different regulations and are not subject to the statutory processes for food additive petitions. TOR substances, i.e., substances used in food-contact articles that become a component of food at levels that are below the threshold of regulation and meet the criteria in Sec. 170.39, are exempt from regulation as food additives and do not require a listing regulation or food additive petition (see Sec. Sec. 170.3(e)(2) and 171.8). As noted in the filing notice for this petition, the procedures for reevaluating and revoking a TOR exemption are set forth in Sec. 170.39(g). These procedures are distinct from the food additive petition process. A request to revoke a TOR exemption is the proper subject of a citizen petition submitted under 21 CFR 10.30. The petition's request that we issue a new regulation under part 189 also falls outside the scope of a food additive petition. A proposed part 189 regulation does not propose the issuance of a new food additive regulation or the amendment or repeal of an existing food additive regulation (see sections 409(b)(1) and (i) of the FD&C Act). Under part 189, an interested person can use the citizen petition process to request a regulation prohibiting a substance from human food (see Sec. 189.1(c) (referring to 21 CFR part 10, which sets forth FDA's citizen petition process)). Although the requests to revoke the approval of TOR exemption No. 2005-006 and to issue a new regulation under part 189 are outside the scope of a food additive petition, for reasons of administrative efficiency, we initially considered these requests in conjunction with the petition's request to amend Sec. 177.1210 to remove potassium perchlorate as an allowed additive in sealing gaskets for food containers. Because the food additive use of potassium perchlorate has been removed from Sec. 177.1210 in response to the abandonment petition, it is neither necessary nor an efficient use of resources to address the petition's assertions regarding this use of perchlorate. Nonetheless, because we considered all of these requests together for purposes of administrative efficiency, we are addressing the [[Page 20850]] petition's requests to revoke the approval of TOR exemption No. 2005- 006 and to issue a new regulation under part 189 in this document. However, although we are addressing these requests in connection with our denial of a food additive petition, we emphasize that these requests are not the proper subject of a food additive petition. Our denial of these two requests is a final Agency decision, but is not an order under section 409(c)(1)(B) of the FD&C Act. D. Background on Perchlorate Perchlorate can interfere with the normal functioning of the thyroid gland by competitively inhibiting the transport of iodide into the thyroid. Iodide is an important component of two thyroid hormones, T4 and T3, and the transfer of iodide from the blood into the thyroid is an essential step in the synthesis of these two hormones. Iodide transport into the thyroid is mediated by a protein molecule known as the sodium (Na+)-iodide (I-) symporter (NIS). NIS molecules bind iodide with high affinity, but they also bind other ions that have a similar shape and electric charge, such as perchlorate. The binding of these other ions to the NIS can inhibit iodide transport into the thyroid, which can result in intrathyroidal iodide deficiency and consequently decreased synthesis of T4 and T3 (73 FR 60262, 60266, October 10, 2008). In fetuses, infants, and young children, thyroid hormones are critical for normal growth and development. Id. at 60275. For example, sustained thyroid hormone decrement in a pregnant mother could lead to adverse neurodevelopmental effects in the fetus. Id. at 60266. Research in this area is ongoing. As part of its discussion asserting that new information is available that raises question as to the safety of the allowed food- contact uses of perchlorates, the petition cited two reviews on perchlorate requested by the Environmental Protection Agency (EPA): A 2005 National Research Council (NRC) review (Ref. 2) and the 2013 report of the EPA's Scientific Advisory Board (SAB) (Ref. 3). The 2005 NRC report noted that thyroid iodide uptake inhibition (IUI) is the only effect that has been consistently documented in humans exposed to perchlorate. Therefore, as part of its review, the NRC utilized a hypothetical mode-of-action (MOA) framework, which represents a continuum of possible biological effects resulting from perchlorate exposure, to describe the potential pathway of events following perchlorate exposure. This MOA framework hypothesized that IUI could induce thyroid hormone changes to an extent that could ultimately result in neurodevelopmental effects in fetuses and infants. The SAB utilized a similar MOA framework. In both MOA frameworks, IUI is the determinant, non-adverse precursor effect, which must occur prior to any later adverse effect. 1. 2005 NRC Review The 2005 NRC report was prepared in response to a request from the EPA that the National Academy of Sciences review the science regarding potential adverse effects of disruption of thyroid function and provide recommendations to apply this information to a risk assessment for environmental contamination from perchlorate. The report recommended that EPA derive a reference dose (RfD) for perchlorate by applying a tenfold intraspecies uncertainty factor to a no observed effect level (NOEL) based on the initiation of IUI as determined in a human study (Ref. 4). (The RfD is an estimate (with uncertainty spanning perhaps an order of magnitude) of a daily oral exposure to the human population (including sensitive subgroups) that is likely to be without an appreciable risk of deleterious effects during a lifetime. The NOEL is an exposure level at which there are no statistically or biologically significant increases in frequency or severity of any effect between the exposed population and its appropriate control.) The NRC stated that this approach was conservative and protective of health given that the NOEL is based on the non-adverse effect of IUI, which precedes the continuum of possible adverse effects as a result of perchlorate exposure. According to the NRC, the application of the uncertainty factor accounts for differences in sensitivity between the healthy human subjects of the determinant clinical study and ``even the most sensitive populations'' for perchlorate exposure, which the NRC identified as fetuses of pregnant women who may have hypothyroidism or iodide deficiency. (Hypothyroidism is a condition where ``the thyroid gland does not produce enough thyroid hormones to meet the body's needs'' (Ref. 5)). EPA adopted the NRC's recommendations resulting in an RfD of 0.7 micrograms perchlorate/kilogram body weight/day ([mu]g/kg bw/d) (Ref. 6). 2. 2013 EPA SAB Report The 2013 SAB report was developed in response to a request by EPA for guidance on a suitable approach to utilize relevant available information to derive a maximum contaminant level goal (MCLG) for perchlorate in drinking water. The Safe Drinking Water Act defines an MCLG as the level of a contaminant in drinking water ``at which no known or anticipated adverse effects on the health of persons occur and which allows for an adequate margin of safety.'' 42 U.S.C. 300g- 1(b)(4). An MCLG is a nonenforceable public health goal. EPA generally derives an MCLG using the RfD and specific chemical exposure factors. (Ref. 7). Rather than this default approach, the SAB recommended that EPA expand existing physiologically-based pharmacokinetic/ pharmacodynamics (PBPK/PD) models to relate perchlorate exposure, in combination with iodide intake, beyond IUI to downstream MOA framework effects, such as resultant thyroid hormone perturbations and potential adverse neurodevelopmental outcomes. The SAB also recommended that the sensitive populations for exposure to perchlorate that EPA should consider when determining an MCLG are the fetuses of hypothyroxinemic pregnant women (hypothyroxinemia means that the free thyroxine (fT4) value is at lower end of the normal range with normal levels of thyroid stimulating hormone (Ref. 8)) and infants exposed to perchlorate through either water-based formula preparations or the breast milk of lactating women. III. Review of the Petition The petition asserted that the original request for TOR exemption No. 2005-006 contained errors that should have made the request ineligible for a TOR exemption under Sec. 170.39. The petition also asserted that we made additional errors in exempting the proposed use of sodium perchlorate monohydrate from regulation as a food additive. The petition also identified four categories of ``significant new information that raises questions about the dietary concentration or the safety of a substance that [FDA] has exempted from regulation,'' that it contends warrant reevaluation of TOR exemption No. 2005-006 under Sec. 170.39(g). Lastly, the petition asserted that infants are likely to be disproportionately impacted by perchlorate, and that we have an obligation under Executive Order 13045 (see 62 FR 19885, April 23, 1997) to address risks to infants from perchlorate exposure. The petition also requested that FDA issue a new regulation under part 189 to prohibit the use of perchlorate as a conductivity enhancer in the manufacture of antistatic agents to be ``applied to food contact articles.'' We will first address the petition's arguments regarding the review of TOR exemption No. 2005-006, then address [[Page 20851]] the petition's arguments based on ``significant new information,'' then subsequently address the assertions pertaining to our obligation under Executive Order 13045, and finally, the request that we issue a new regulation under part 189. A. Arguments Regarding Review of TOR Exemption No. 2005-006 The petition claimed that multiple errors were made in the original calculation of dietary exposure resulting from the use allowed by the TOR exemption No. 2005-006 and that assumptions used in that calculation were either improperly applied or have been shown to be flawed based on new information available after the TOR exemption became effective. The petition stated further that if these alleged errors were addressed, the dietary exposure resulting from the use allowed by the TOR exemption No. 2005-006 would exceed the TOR exemption criteria. We describe the background for TOR exemption No. 2005-006 in section III.A.1. The issues raised in the petition concerning alleged errors in the original calculation and assumptions used in that calculation, as well as our responses to those issues, are discussed in sections III.A.2 through III.A.6. 1. Background for TOR Exemption No. 2005-006 Our regulations, at Sec. 170.39(a)(2), provide the exposure criteria for a TOR exemption. As stated in Sec. 170.39(a)(2)(i), the use of a substance will be exempted from regulation as a food additive if the use in question is shown to result in or may be expected to result in dietary concentrations at or below 0.5 parts per billion (ppb), corresponding to dietary exposure levels at or below 1.5 [micro]g of substance/person/day (based on a diet of 1,500 grams (g) of solid food and 1,500 g of liquid food per person per day). As noted in section II.A.2, Sec. 170.39(g) sets forth the procedures for reevaluating and revoking a TOR exemption. We have issued guidance documents to help interested parties when preparing premarket submissions for food contact substances. Our guidance document specific to chemistry recommendations for food contact substances (Ref. 9) (``chemistry guidance'') provides recommendations for: (1) Migration protocols to determine or estimate the concentration of a food contact substance in the specific food that contacts a given food-contact article containing the substance as a result of the intended use of that substance (``the migration of a substance'') and (2) how to use this information to calculate the resultant total dietary exposure to the substance as a result of its intended use. Our chemistry guidance provides general protocols for food-contact articles intended for single use, as well as general recommendations for articles intended for repeated use. The chemistry guidance also provides recommended migration protocols for certain specific use applications, including articles intended for use only with non-fatty, dry foods (termed ``Food Type VIII'' in our chemistry guidance). Specific to non-fatty, dry foods, the recommended protocol includes an assumption that a food contact substance migrates into non-fatty, dry foods at a level of 50 [micro]g substance per kilogram food, or 50 ppb. To determine total dietary exposure to a substance as a result of its intended use, the chemistry guidance recommends the application of a consumption factor to the concentration in food determined from the migration protocol. The consumption factor describes the fraction of the daily diet expected to contact a specific type of packaging material. Consumption factors are derived using information on the types of food consumed, the types of food contacting each packaging surface, the number of food packaging units in each food packaging category, the distribution of container sizes, and the ratio of the weight of food packaged to the weight of the package (Ref. 9). The request for TOR exemption No. 2005-006 was submitted to FDA by Ciba Specialty Chemicals Corporation (Ciba) on June 17, 2005. Although Ciba calculated exposure for sodium perchlorate monohydrate, in this document we convert Ciba's exposure numbers to exposure to the perchlorate anion (the substance of toxicological concern is the perchlorate anion and EPA's RfD for perchlorate is expressed on a perchlorate anion basis). To determine the concentration of perchlorate anion (i.e., ``perchlorate'') in food that contacts finished articles containing sodium perchlorate monohydrate as a result of TOR exemption No. 2005-006, Ciba applied the percentage of sodium perchlorate monohydrate in the finished food-contact article to the 50 ppb migration concentration assumption for non-fatty, dry foods listed in our chemistry guidance. This resulted in a sodium perchlorate monohydrate concentration in food of 0.6 ppb, which corresponds to a concentration of 0.4 ppb for perchlorate in food. To determine a total dietary concentration for perchlorate as a result of this specific use, Ciba then applied our consumption factor for substances that may be used in all polymers but only for specific uses (0.05) to this concentration value. This resulted in a total dietary concentration for sodium perchlorate monohydrate of 0.03 ppb, or 0.02 ppb for perchlorate. For comparison against the TOR exemption exposure criteria stipulated in Sec. 170.39(a)(2)(i), Ciba subsequently multiplied this total dietary concentration by FDA's assumption that an individual consumes 3 kg of food per day. This resulted in a dietary exposure of 0.09 [micro]g sodium perchlorate monohydrate/person/day, or 0.063 [micro]g perchlorate/person/day. A review that we conducted before TOR exemption 2005-006 became effective determined that the provided information demonstrated that the use would result in a dietary exposure below the 1.5 [micro]g/person/day TOR exemption criteria (Ref. 10). 2. Issues Pertaining to Calculations Based on FDA's Chemistry Guidance The petition asserted that Ciba deviated from the recommendations provided in FDA's chemistry guidance when calculating the exposure to perchlorate that results from the intended use for the TOR exemption No. 2005-006. Specifically, the petition asserted that applying the percentage of sodium perchlorate monohydrate in the finished food- contact article to the 50 ppb migration concentration assumption deviates from the recommended migration protocol for non-fatty, dry foods and improperly made Ciba's intended use for sodium perchlorate monohydrate eligible for a TOR exemption. Furthermore, the petition said that the original TOR exemption submission did not account for the recommendations presented in FDA's chemistry guidance for substances in food-contact articles intended for repeated-use. a. Applying the percentage of sodium perchlorate in the finished food-contact article to the 50 ppb migration concentration assumption. The petition asserted that Ciba ``varied'' from our chemistry guidance when it ``inserted the amount of perchlorate in the formulation (4%) and the amount of formulation in the packaging (30%) into'' the equation for calculating the dietary concentration of sodium perchlorate monohydrate. Specifically, Ciba applied the percentage of sodium perchlorate monohydrate in the finished food-contact article (4% x 30% = 1.2%) to the 50 ppb migration concentration assumption. We acknowledge that our chemistry guidance does not specifically discuss a procedure for applying the percentage of [[Page 20852]] a substance in the finished food-contact article to the 50 ppb migration concentration assumption for the food contact substance, but applying such a percentage to a migration concentration assumption does not deviate from that guidance. The migration protocol for Food Type VIII is written at a general level and does not preclude scientifically appropriate calculations based on the percentage of a food contact substance when using the 50 ppb migration concentration assumption. We believe it was scientifically appropriate for Ciba to apply the percentage of the food contact substance in the finished packaging to the 50 ppb migration concentration assumption. Ciba's calculation noted that sodium perchlorate monohydrate represents only a small fraction of the antistatic agent in which it is used (4 percent), and the antistatic agent itself represents only a fraction of the finished food-contact article in which it is used (30 percent). Therefore, absent contradictory data, it is scientifically reasonable to assume that sodium perchlorate monohydrate migrates to Food Type VIII at the level that it is present in the finished food-contact article (i.e., 1.2 percent of the 50 ppb migration concentration assumption). Such percentages have been applied to migration concentration assumptions in other submissions that have been approved or become effective (Ref. 11). We also note that the chemistry guidance states that dry foods with the surface containing no free fat or oil typically exhibit little or no migration, and cites volatile or low molecular weight adjuvants as examples of substances that would be expected to migrate into non- fatty, dry foods. Sodium perchlorate monohydrate is an ionic compound with low volatility and therefore would not be expected to migrate from food-contact materials into non-fatty, dry foods (Ref. 11). Therefore, there is no scientific basis to suggest that sodium perchlorate monohydrate would migrate into non-fatty, dry foods at a higher percentage of the 50 ppb migration concentration assumption than its percentage in the food-contact article. The appropriateness of Ciba's approach of applying the percentage of sodium perchlorate monohydrate in the finished food-contact article to the 50 ppb migration concentration assumption is supported by available analytical data provided in comments to the docket for the petition. The migration protocol specific to non-fatty, dry foods provided in our chemistry guidance recommends either the estimation of the migration of a substance using the 50 ppb migration concentration assumption or the determination of the actual migration via appropriate migration studies. Comments submitted to the docket for the petition include a migration study for sodium perchlorate monohydrate from a worst-case polymeric resin into a simulant for non-fatty, dry foods (see Docket Nos. FDA-2015-F-0537, Supplemental Comments from BASF Corporation (Keller and Heckman LLP) (FDA-2015-F-0537-18), BASF Corp Migration Report (Redacted) re: Supplemental Comments from BASF Corporation (Keller and Heckman LLP) (FDA-2015-F-0537-19), BASF Corporation Appendix A--Analysis Method (Redacted) re: Supplemental Comments from BASF Corporation (Keller and Heckman LLP) (FDA-2015-F- 0537-20), BASF Corporation Appendix B--Detailed Sample Analysis Data (Redacted) re: Supplemental Comments from BASF Corporation (Keller and Heckman LLP) (FDA-2015-F-0537-21), BASF Corporation Appendix C-- Chromatograms (Redacted) re: Supplemental Comments from BASF Corporation (Keller and Heckman LLP) (FDA-2015-F-0537-22), and BASF Corporation Appendix D--Spiking Validation at Low Perchlorate (Redacted) re: Supplemental Comments from BASF Corporation (Keller and Heckman LLP) (FDA-2015-F-0537-23)). We reviewed this study and determined that it is adequate to determine worst-case migration of perchlorate into non-fatty, dry foods as a result of the use specified in the TOR exemption No. 2005-006 (Ref. 11). As such, the migration concentration in food for perchlorate as determined from this migration study can be used to verify the appropriateness of Ciba's approach of applying the percentage of sodium perchlorate monohydrate in the finished food-contact article to the 50 ppb migration concentration assumption. The migration study reported its results on a basis of grams of perchlorate per surface area of test sample. To convert this reporting basis to grams of perchlorate per gram of food, we applied our standard assumption for the food mass-to-surface area ratio for consumer packaging (10 g of food contacting each square inch of food-contact article) to the results of the migration study. This results in a migration concentration of 0.5 nanogram (ng) perchlorate/g food, or 0.5 ppb. This value is substantially less than the 50 ppb migration concentration assumption provided in our chemistry guidance and is essentially equivalent to the 0.4 ppb concentration for perchlorate in food calculated using Ciba's approach in its TOR submission. The dietary exposure to perchlorate calculated using the concentration for perchlorate in food obtained from the migration study (0.075 [mu]g/ person/day) is also essentially equivalent to that calculated using Ciba's approach (0.063 [micro]g/person/day) and is lower than the TOR exemption criteria of 1.5 [mu]g/person/day. The results of the migration study confirm that Ciba's approach to calculating migration was scientifically appropriate. Both the migration study and Ciba's approach resulted in dietary exposure figures for sodium perchlorate monohydrate that were lower than the TOR exemption criteria. Therefore, the petition's assertion that the intended use of sodium perchlorate monohydrate would not be eligible for a threshold of regulation exemption if migration had been properly calculated is unfounded. b. Calculation of dietary exposure based on migration protocol. As discussed in section III.A.1, FDA's chemistry guidance discusses general protocols for food-contact articles intended for single-use (e.g., a disposable paper cup), as well as for articles intended for repeated-use (e.g., a reusable ceramic mug). Part I.C.5 of the petition noted that Ciba's calculation of dietary exposure ``did not rely'' on the recommended migration protocol in our chemistry guidance for food- contact articles intended for repeated use. Related to this argument, in the December 5, 2014, submission, the petitioners asserted that Ciba's use of a single-use protocol, rather than a repeated-use protocol, does not account for the release of perchlorate over time ``as the plastic degrades or is flexed.'' Using the single-use protocol results in a higher exposure value than using the repeated-use protocol because: (1) The factors applied to the migration value to determine exposure in the single-use protocol are exaggerative and (2) exposure values from repeated-use articles are typically very small in comparison to single-use articles. Therefore, when a food contact substance will be used in both single- and repeated-use articles, it is more conservative and protective to use the single-use protocol to determine exposure than it is to use the repeated-use protocol. Accordingly, where, as here, a food contact substance is intended to be used in both single- and repeated-use food- contact articles, we use the single-use protocol to determine exposure. We only use the repeated-use protocol for food contact substances that are only used in repeated-use food-contact articles. As Ciba's intended use [[Page 20853]] of sodium perchlorate monohydrate was not limited to repeated-use food- contact articles, its use of the single-use protocol, rather than the repeated-use protocol, was appropriate. i. Background on migration protocols. The migration protocols in the chemistry guidance provide recommendations on: (1) How to determine the total migration of a substance from a given food-contact surface area (migration value) and (2) how to use that migration value to determine dietary exposure to the migrating substance based upon the mass of food the food-contact surface area will come into contact with and the percentage of the diet that mass of food constitutes. The single-use and repeated-use protocols both provide similar recommendations on how to determine the total amount of migration of a substance from a given food-contact surface area; however, they differ in the assumptions used to determine dietary exposure from that migration value. Specifically, to determine dietary exposure, the single-use protocol applies the following factors to the migration value: (1) FDA's standard assumption of the amount of food in contact with a given surface area of a single-use articles (10 g of food contacting each square inch of food-contact article); (2) food-type distribution factors to account for the variable nature of the food contacting each food-contact article (when applicable); and (3) consumption factors (i.e., the fraction of the daily diet expected to contact a specific type of packaging material). Ciba's calculation did not use food-type distribution factors, and we will not discuss such factors further. By comparison, the repeated-use protocol recommends that dietary exposure be determined by applying to the migration value an estimate of the total mass of food contacting a known food-contact surface area over the service life of the article. ii. Use of the single-use protocol for substances in both single- and repeated-use articles. We consider the exposure calculated from the single-use protocol to address the exposure to a food contact substance used in both single- and repeated-use articles for several reasons, including that: (1) The factors applied to the migration value to determine exposure in the single-use protocol are exaggerative and (2) exposure values from repeated-use articles are typically very small in comparison to single-use articles. We consider the factors applied to the migration value to determine exposure in the single-use protocol to be exaggerative for several reasons. For instance, the use of a consumption factor in the single- use protocol assumes that the food contact substance will be used in all food-contact articles that utilize the specific type of material to which the consumption factor applies (as discussed in section III.A.1, consumption factors are specific to a material--e.g., glass, paper, or plastic--in that the consumption factor describes the fraction of the daily diet expected to contact packaging that utilizes that type of material). This is an exaggerative assumption. Food contact substances are used in food-contact articles to perform a specific technological function. It is highly unlikely that all food-contact articles that use the type of packaging material to which a specific consumption factor applies will require that technological function. In addition, the use of a consumption factor does not account for the use of alternative food contact substances that perform the same technological function. The following example illustrates the exaggerative nature of the use of a consumption factor: Under the single-use protocol one could use FDA's consumption factor for colored plastics to determine exposure to a black pigment intended to be added to plastic food packaging. FDA's consumption factor for colored plastics describes the fraction of the daily diet expected to contact packaging that consists of colored plastic, regardless of the color of that plastic. However, not all colored plastic is black, and, therefore, a black pigment would not be added to all colored plastics. In addition, there are multiple black pigments that are authorized to color food-contact articles. Given that alternative black pigments are available for the same purpose, it is unlikely that all black colored plastic packaging would use the particular black pigment at issue. We also note that exposure values from repeated-use articles are typically very small in comparison to single-use articles because individual repeated-use articles come into contact with significantly larger amounts of food over their service lifetime than individual single-use articles. This results in a much greater food mass-to- surface area ratio for repeated-use articles than the 10 g of food contacting each square inch of food-contact article assumption for single-use articles. The greater food mass-to-surface area ratio for repeated-use articles means that the total amount of migration of a substance from a given food-contact surface area (the migration value) is diluted across a much larger amount of food in comparison to a single-use article, resulting in a significantly lower dietary concentration. In conclusion, we consider the exposure to a food contact substance used in both single- and repeated-use articles to be addressed by the exaggerative exposure calculated via the single-use protocol. Therefore, we apply the single-use protocol to food contact substances intended to be used in both single-use and repeated-use food-contact articles. iii. Applying worst-case assumptions to available migration information. In any event, we note that the migration study described in section III.A.2.a followed equivalent or more stringent specifications than those recommended in the single- and repeated-use protocols. In section III.A.3, we explain that, even if the absolute worst-case assumptions for both the single- and repeated-use protocols discussed in the chemistry guidance--that each square inch of food- contact article will come into contact with 10 g of food, and that the article will come into contact with all food in a consumer's diet (in other words, no consumption factors or food type distribution factors are applied to the migration value)--are applied to the migration value determined from this study, the calculated dietary exposure to perchlorate would still fall within the TOR exposure exemption criteria. As such, the petitioners' assertions that Ciba did not follow the repeated-use protocol discussed in the chemistry guidance document and that use of a single-use protocol did not account for the release (i.e., migration) of perchlorate over time if the finished article degrades or is flexed, do not support the conclusion that TOR exemption No. 2005-006 should be revoked. 3. Issues Pertaining to the Use of a Consumption Factor When Calculating Dietary Exposure The original calculation of dietary exposure resulting from the use allowed by the TOR exemption No. 2005-006 used FDA's consumption factor for substances that may be used in all polymers but only for specific uses. The petition asserted that the use of a consumption factor in this instance is inappropriate for a variety of reasons, including that the consumption factor does not account for the use of sodium perchlorate monohydrate in all antistatic agents and all polymers, nor in reusable bulk packaging for raw materials which the petition said result in finished articles containing sodium perchlorate monohydrate coming into contact with food ingredients that will later be used in the production of [[Page 20854]] processed foods which are not limited to non-fatty, dry foods. To address the petition's assertions regarding the appropriateness of the use of a consumption factor, we used the results of the migration study provided in comments submitted to the docket for the petition (discussed in section III.A.2.a) to calculate the dietary exposure to perchlorate from the use allowed by TOR exemption No. 2005- 006 without the use of a consumption factor (Ref. 11). This approach overestimates the dietary exposure from the use allowed by TOR exemption No. 2005-006 because it assumes that finished articles containing sodium perchlorate monohydrate will come into contact with all foods in a consumer's diet instead of coming into contact with just non-fatty, dry foods. This approach also assumes that all food will come into contact with articles containing sodium perchlorate monohydrate at the maximum allowed use level, which is a conservative assumption because it can be expected that not all finished articles would utilize the substance at the maximum allowed use level. In addition, this calculation utilizes our food mass-to-surface area ratio assumption for consumer (single use) packaging, even though it can be expected that food-contact articles used in food processing and raw material storage have a much larger food mass-to-surface area ratio than consumer packaging (see discussion in section III.A.2.b.ii). Using this conservative approach, we calculated a perchlorate exposure of 1.5 [micro]g/person/day, which falls within the TOR exemption criteria specified in Sec. 170.39(a)(2)(i) even without the use of a consumption factor. This calculation demonstrates that the assertions raised in the petition pertaining to the use of a consumption factor do not support a conclusion that TOR exemption No. 2005-006 is no longer supportable under Sec. 170.39(g). 4. Inclusion of Use in Contact With Infant Formula and Food for Children Younger Than Two Years Old As discussed in section III.A.1, the original submission for TOR exemption No. 2005-006 calculated the dietary exposure to perchlorate from the intended use of sodium perchlorate monohydrate. This calculation used several factors, including a consumption factor as well as an assumption of a total food consumption of 3 kg of food per day. Section I.C.3 of the petition stated that because these factors are specific to adults, exposure calculated using these factors could underestimate perchlorate exposure for infants relying on powdered formula as their sole source of nutrition if sodium perchlorate monohydrate was used in infant formula packaging as a result of TOR exemption No. 2005-006. The petition stated that many infants rely on infant formula as their sole source of nutrition, whereas adults consume a diverse diet. The petition also stated that infants consume more food per bodyweight than adults. a. Section 170.39(a)(2)(i) and the use of specific factors to calculate exposure. As discussed in section III.A.1, Sec. 170.39(a)(2)(i) requires that dietary exposure be calculated using a specified assumption of 3 kg of food per day, which is an assumption for the general adult population. In addition, Sec. 170.39(a)(2)(i) requires that dietary exposure be expressed on a per person basis ([micro]g/person/day), which does not account for the fact that infants consume more food per bodyweight than adults. To account for the fact that infants consume more food per bodyweight than adults, infant dietary exposure would need to be expressed on a bodyweight basis ([micro]g/kg bodyweight/day). Section 170.39(a)(2)(i) does not preclude the use of a consumption factor when calculating exposure; as discussed in section III.A.3, the use of a consumption factor refines exposure by taking into account the fraction of the daily diet expected to contact a specific type of packaging material rather than assuming a given food contact substance will be used in contact with all food in a consumer's diet. However, in section III.A.3 we also demonstrate that the dietary exposure to perchlorate that results from the intended use subject to TOR exemption 2005-006 falls within the TOR exemption criteria even if that exposure is calculated without the use of a consumption factor. b. Section 170.39(b) and infant exposure to perchlorate from the TOR use. Although the intended use for TOR exemption No. 2005-006 results in an exposure of 1.5 [mu]g/person/day or less using the assumptions specified in Sec. 170.39(a)(2)(i), under Sec. 170.39(b) we can decline to grant a TOR exemption in those cases where the available information establishes that the proposed use may pose a public health risk. In certain circumstances, we believe that infants' dietary exposure to a substance may be relevant to whether the proposed use of a substance may pose a public health risk under Sec. 170.39(b). Therefore, to address the petition's argument that the use of adult- specific exposure assumptions could underestimate perchlorate exposure for infants that solely consume reconstituted powdered formula, we calculated a potential exposure to perchlorate in powdered formula from the intended use allowed by TOR exemption No. 2005-006. We calculated this potential infant dietary exposure by applying infant-specific exposure assumptions articulated in FDA's draft guidance for food contact notification submissions for food contact substances that contact infant formula or human milk (Ref. 12), to data from the migration study provided in comments submitted to the docket for the petition (discussed in Section III.A.2.). These infant-specific dietary exposure assumptions include an assumption that an infant (aged 0 to 6 months) consumes 900 g of liquid formula per day (data from the National Health and Nutrition Examination Survey indicate that the highest mean intake for infants 0-6-months is for 2-month old infants, which have an intake of 900 grams/day). FDA also used the corresponding mean body weight of 2-month olds of 6.3 kg bodyweight/infant. The infant-specific potential dietary exposure estimate excludes the use of a consumption factor, because infants aged 0 to 6 months frequently consume human milk and/or infant formula exclusively. Using this approach, we calculated a potential infant dietary exposure to perchlorate in powdered formula from the intended use allowed by TOR exemption No. 2005-006 of 0.019 [micro]g/kg bodyweight/day (Ref. 11). As discussed in section III.B, the petition discusses the safety of perchlorate exposure in the context of the RfD for perchlorate, as well as a value derived from a preliminary, biologically based dose-response model. This calculated potential perchlorate exposure for powdered formula is less than both the RfD for perchlorate (0.7 [micro]g/kg bodyweight/day) and the value derived from the model (0.42 [micro]g/kg bodyweight/day). Thus, the petition does not demonstrate that there is a public health risk to infants under Sec. 170.39(b) as a result of the intended use of perchlorate allowed by TOR exemption No. 2005-006. 5. Consideration of Exposure From Other Sources The petition asserted that section 409(c)(5)(B) of the FD&C Act and Sec. 170.3(i)(2) require consideration of cumulative exposure to perchlorate in the review of TOR exemption No. 2005-006 and that, if these exposures are considered when calculating the dietary exposure for the TOR exemption, the resultant exposure may exceed the TOR exemption criteria of dietary exposure at or below 1.5 [micro]g/person/ day. Specifically, the petition stated that the [[Page 20855]] original calculation of dietary exposure resulting from the use allowed by TOR exemption No. 2005-006 did not consider dietary exposure to perchlorate as a result of the approved food-contact use of potassium perchlorate listed in Sec. 177.1210, nor as a result of environmental contamination of the food supply. The use of a food contact substance that is exempted from regulation as a food additive under FDA's TOR regulation is not subject to the factors that apply to the proposed use of a food additive under section 409(c)(5)(B) of the FD&C Act and Sec. 170.3(i)(2). Rather, when we exempt a food-contact use of a substance from regulation as a food additive, our TOR regulation ensures the safety of this food- contact use by setting extremely low limits on migration levels so that its proposed use results in a negligible dietary concentration, and requiring that the substance not be a carcinogen. A premise of the TOR regulation is that if a substance meets these requirements, it presents no other health or safety concerns (see Sec. 170.39(a)(2)). In determining whether the use of a substance qualifies for a TOR exemption, cumulative exposure to a substance is not considered under the TOR regulation because the dietary exposure from the use of a substance that is at or below the threshold of regulation is negligible. Thus, Sec. 170.39(a)(2)(i) provides that the only dietary exposure that is relevant to whether the use of a substance qualifies for a TOR exemption from regulation as a food additive is the dietary exposure resulting from the use in question. We established the threshold of regulation set forth in Sec. 170.39(a)(2)(i) based on available toxicological data showing that it was feasible to establish a threshold level below which dietary exposures to substances used in food-contact articles are so negligible as to pose no public health or safety concerns (see 60 FR 36582, July 17, 1995). In the preamble to the proposed TOR rule, we explained that our analysis of toxicological data on a large number of representative compounds demonstrated that the noncarcinogenic toxic effects caused by the majority of unstudied compounds would be unlikely to occur below 1,000 ppb (58 FR 52719 at 52722, October 12, 1993). To provide an adequate safety margin, we selected 0.5 ppb as the threshold for regulation, which is 2,000 times lower than the dietary concentration at which the vast majority of studied compounds are likely to cause noncarcinogenic toxic effects (see 58 FR 52719 at 52722). We also analyzed potency data on a large number of known carcinogens to determine that the 0.5 ppb dietary concentration level would result in negligible risk, even in the event that a substance that is exempted from regulation as a food additive were later shown to be a carcinogen (see 58 FR 52719 at 52722). Consistent with Sec. 170.39(a)(2)(i), we do not calculate cumulative exposure to a substance in evaluating whether the use of the substance qualified for a TOR exemption. As we explained in an April 2002 guidance for industry entitled, ``Preparation of Food Contact Notifications for Food Contact Substances: Toxicology Recommendations,'' at the time the TOR process was established, FDA determined that, because of the conservative assumptions ordinarily applied in estimating exposure, the cumulative exposure from a limited number of trivial food additive uses is not likely to be more than negligible. Accordingly, in the case of the TOR exposure levels, it was not necessary to utilize cumulative exposure levels. FDA believes that the determination made in establishing its TOR is still sound (Ref. 13). Therefore, contrary to the petition's assertions, under FDA's TOR regulations, the dietary exposures to perchlorate that are not a result of the use specified in the TOR exemption No. 2005-006 are not considered under the exposure criteria for the TOR exemption. 6. Inconsistencies Between the Intended Use Reviewed by FDA and That Listed on Our Inventory of Effective TOR Exemptions We maintain an inventory of effective TOR exemptions on our Web site (Ref. 1). The originating submission for TOR exemption No. 2005- 006 requested a use for sodium perchlorate monohydrate in antistatic agents at a maximum level of 4 percent by weight. The antistatic agent would be used in finished plastic at a maximum level of 30 percent by weight. The finished plastic would be used in contact with non-fatty, dry foods (Food Type VIII) only. This is the intended use that we considered in 2005 when we determined that the information provided in the originating request demonstrated that the use would result in a dietary exposure at or below the 1.5 [micro]g/person/day criteria. The petition asserted that this intended use was expanded in the final letter for the TOR exemption No. 2005-006 to permit the finished article to be used in contact with all dry foods. The petition also asserted that the intended use was further expanded in the listing on our inventory of effective TOR exemptions, to include the use of sodium perchlorate monohydrate in all types of food contact materials at a maximum use level of 4 percent by weight in the finished article. We agree that the intended use for TOR exemption No. 2005-006 was inaccurately described in the final letter for the TOR exemption No. 2005-006 and the inventory of effective TOR exemptions. On August 17, 2015, we corrected the listing for TOR exemption No. 2005-006 on the inventory of effective TORs on our Web site to be consistent with the intended use reviewed by FDA when the TOR exemption became effective and thereby address the petition's assertions regarding the description of the intended use for TOR exemption No. 2005-006. We further revised the listing for TOR exemption No. 2005-006 on September 19, 2016, to clarify that TOR exemption No. 2005-006 allows the use of perchlorate in the manufacture of antistatic agents for use in all polymeric food- contact articles and not only polymeric food packaging. B. Arguments Based on ``Significant New Information'' Part I.D. of the petition identified the following four categories of ``significant new information'' that has become available after TOR exemption No. 2005-006 became effective: ``First, additional research shows that the endpoint used in the decision was not the most appropriate or sensitive one to protect fetuses and infants from permanent brain damage. Second, it is now known that nitrates and thiocyanates are pharmacologically-related to perchlorate and, therefore, must be considered in any safety evaluation of perchlorate as an additive. Third, in 2011, FDA acknowledged that the 50 ppb migration to dry-food default assumption (``virtually nil'' migration) may be flawed based on research evidence from Europe. Fourth, FDA has demonstrated that there is widespread contamination of the food supply with perchlorate that must be considered.'' The petition asserted that this new information warrants a reevaluation of TOR exemption No. 2005- 006 under Sec. 170.39(g). We will first address the petition's arguments regarding hypothyroxinemia and its proposed acceptable daily intake level, then discuss the petition's arguments pertaining to perchlorate in the food supply and pharmacologically related substances, and finally the arguments pertaining to our 50 ppb migration concentration assumption. [[Page 20856]] 1. Proposed Acceptable Daily Intake Level Based on Hypothyroxinemia The petition proposed an acceptable daily intake (ADI) value in place of the RfD for perchlorate and argues that the exposure from the TOR use exceeds the ADI proposed in the petition. The petition stated that the ADI proposed in the petition better accounts for hypothyroxinemia as a potential result of perchlorate exposure than does the RfD. However, under our TOR regulations, because a substance is expected to migrate into food at negligible levels, a non- carcinogenic endpoint such as hypothyroxinemia is not relevant unless the use of the substance may pose a public health risk under Sec. 170.39(b). As discussed further in this section, the information in the petition does not support such a conclusion under Sec. 170.39(b) because: (1) Even if hypothyroxinemia were relevant, the petition does not demonstrate that the proposed ADI better accounts for the potential for perchlorate to cause hypothyroxinemia than the RfD for perchlorate; (2) the proposed ADI is based on the results of a preliminary model; and (3) even if it were appropriate to base an ADI on the results of the preliminary model, the resulting ADI would still be above the exposure from the TOR use. a. Summary of petition's discussion on hypothyroxinemia. The petition asserted that new information, available since TOR exemption No. 2005-006 became effective, demonstrates that exposure to perchlorate can result in hypothyroxinemia. As noted in section I.D.2, hypothyroxinemia means that the fT4 value is at the lower end of the normal range with normal levels of TSH in the blood. The petition asserted that the SAB report, which was issued after the TOR exemption became effective, identified the potentially sensitive population for perchlorate exposure to be fetuses of hypothyroxinemic pregnant women. This is in contrast to the NRC report, which identified the potentially sensitive population for perchlorate exposure to be fetuses of pregnant women with hypothyroidism or iodide deficiency (both the SAB report and the NRC report are discussed in section I.D.2). Based upon this difference, the petition asserted that the RfD, which was based on the NRC review, does not provide sufficient protection to susceptible populations. The petition also asserted that IUI, which is the basis of the RfD, is a less sensitive endpoint than hypothyroxinemia. The petition proposed an ADI of 0.042 [micro]g/kilogram bodyweight/ day for perchlorate based on the amount of perchlorate exposure that may result in hypothyroxinemia in iodide-deficient pregnant women as reported by FDA scientists in a 2013 Lumen et al. article (Ref. 14). Lumen et al. summarizes the results of a proof-of concept, biologically based dose-response (BBDR, also known as a PBPK/PD) model that is specific to near-term human mothers and fetuses. This model used PBPK/ PD data to predict perchlorate intake levels that could produce thyroid hormone perturbations at varying levels of maternal iodide intake. The petition derived its proposed ADI by applying two ten-fold uncertainty factors to the results presented in the Lumen et al. article. One ten- fold uncertainty factor is applied to account for intraspecies variability, while the second tenfold uncertainty factor is applied to account for the assertion that the perchlorate exposure value provided in the Lumen et al. article is based on a lowest observed adverse effect level (LOAEL) rather than a no observed adverse effect level (NOAEL). (The petition also stated that additional, unquantified uncertainty factors should be applied to its proposed ADI to account for deficiencies in the model, but it does not include these factors in its calculation of the proposed ADI.) The petition subsequently compared its proposed ADI to a dietary exposure to perchlorate resulting from the use allowed by TOR exemption No. 2005-006 as calculated in the petition. As the exposure to perchlorate calculated in the petition is higher than the derived ADI, the petition asserted that TOR exemption No. 2005-006 should be revoked. b. FDA's consideration of the petition's discussion on hypothyroxinemia. First, the petition contended that its proposed ADI accounts for the potential for perchlorate to cause hypothyroxinemia while the RfD for perchlorate does not. However, the petition does not adequately support its assertion that the RfD for perchlorate fails to account for the potential for perchlorate to cause hypothyroxinemia (Ref. 15). The SAB's and NRC's identification of different sensitive populations for perchlorate exposure is not a basis for concluding that the RfD provides insufficient protection to the sensitive population identified by the SAB, nor that the RfD does not account for the potential for perchlorate to cause hypothyroxinemia. The RfD for perchlorate is based on the IUI. As previously stated, the basis of the MOA framework for perchlorate is that IUI must first occur prior to any resultant thyroid hormone perturbations such as hypothyroxinemia or hypothyroidism. This contradicts the petition's assertion that IUI is a less sensitive endpoint than hypothyroxinemia. The NRC and SAB used the MOA framework for perchlorate in determining their recommendations. The MOA framework was also used in the development of the Lumen et al. BBDR model cited by the petitioners (Ref. 14). Furthermore, the tenfold intraspecies uncertainty factor utilized by the NRC in the derivation of the RfD is a default value that is intended to account for the entire range of sensitivity among humans to perchlorate exposure. The petition did not provide support for its contention that this default, intraspecies uncertainty factor is not inclusive of fetuses of pregnant women with hypothyroxinemia. Second, the 2013 Lumen et al. BBDR model that forms the basis of the ADI proposed by the petitioners is a preliminary model (Ref. 15) that FDA believes is not appropriate to use in a quantitative risk assessment as presented in the petition. Because FDA does not believe that the model should be used for a quantitative risk assessment due to the preliminary nature of the analysis, consideration of the appropriateness of the uncertainty factors proposed by the petitioners is premature at this time. Since the 2013 Lumen et al. article, we have worked with EPA scientists to further develop the model cited by the petitioners. On January 10 and 11, 2017, EPA's contractor conducted an independent, scientific public peer review of EPA's draft BBDR model and report. EPA is currently considering peer reviewer comments. EPA intends to seek peer review of a second report that evaluates methods to apply the final BBDR model to develop a maximum contaminant level goal for perchlorate in drinking water (see 81 FR 87553, December 5, 2016). Third, we note that even if the approach taken in the petition were appropriate--i.e., to calculate a risk assessment value based on the results of the preliminary model referenced in the petition, and to apply both 10-fold uncertainty factors specified in the petition (one to account for a LOAEL and one to account for intraspecies variability) to the amount of perchlorate exposure that may result in hypothyroxinemia in iodide-deficient pregnant women as reported in the Lumen et al. article--the resultant ADI calculated in the petition is 0.042 [mu]g/kg bodyweight/day. This risk assessment value is higher than the exposure to [[Page 20857]] perchlorate as a result of TOR exemption No. 2005-006 as determined by Ciba (0.063 [mu]g per chlorate/person/day, which equates to 0.001 [mu]g/kg bodyweight/day utilizing FDA's assumption of 60 kg bodyweight for adults as described in the chemistry guidance), as well as the exposures determined from the migration study discussed in section II.A.2 (for adults: 0.075 [mu]g/person/day which equates to 0.001 [mu]g/kg bodyweight/day; and for infants: 0.019 [mu]g/kilogram bodyweight/day--see section II.A.4). Therefore, even if deriving a risk assessment value based on the results presented in the Lumen et al. article were appropriate, the exposure to perchlorate as a result of TOR exemption No. 2005-006 is lower than the resulting risk assessment value, and therefore would not support the assertion by the petitioners that the results presented in the Lumen et al. article ``raises questions about the safe level of exposure to perchlorate relied on by Ciba when the Agency approved TOR No. 2005-006.'' 2. Argument Related to Cumulative Dietary Exposure From Perchlorate, and Substances Pharmacologically Related to Perchlorate, in the Food Supply The petition asserted that new information has become available, since FDA issued the listing regulation for potassium perchlorate in Sec. 177.1210 and TOR exemption No. 2005-006, that nitrate and thiocyanate are pharmacologically related to perchlorate, and that perchlorate contamination of the food supply is widespread. The petition also asserted that we are required to take into account the cumulative effect of these substances in the diet. As discussed in section III.A.5, under Sec. 170.39(a)(2)(i), we do not calculate cumulative dietary exposure to a substance or pharmacologically related substances in evaluating whether the use of the substance qualifies for a TOR exemption from regulation as a food additive. Under Sec. 170.39(a)(2)(i), the only dietary exposure that is relevant to whether the use of a substance qualifies for a TOR exemption from regulation as a food additive is the dietary exposure resulting from the use in question. Therefore, the petition's argument regarding cumulative dietary exposure to perchlorate or pharmacologically related substances does not support a conclusion that TOR exemption No. 2005-006 is no longer supportable. 3. Alleged Flaws in FDA's 50 ppb Migration Concentration Assumption The petition stated that FDA, in a 2011 speech by an FDA scientist, acknowledged potential flaws in the 50 ppb migration concentration assumption for migration to non-fatty, dry foods (Food Type VIII). To support this statement, the petition cited a 2011 article which summarizes the speech given by the FDA scientist (Ref. 16). The petition also asserted that the 50 ppb migration assumption is particularly flawed for perchlorate, which is used in packaging to neutralize the static charge on dry food. The migration study provided in comments submitted to the docket for the petition (discussed in section III.A.2.a) found that perchlorate migrated into a simulant for non-fatty, dry foods at a concentration of 0.5 ng perchlorate/g food, or 0.5 ppb. As noted, this value is substantially less than the 50 ppb migration concentration assumption provided in our chemistry guidance and indicates that the 50 ppb migration concentration assumption does not understate migration from the intended use of sodium perchlorate monohydrate into non-fatty, dry foods. As a result, the petition's contentions regarding alleged flaws in the 50 ppb migration concentration assumption, both generally and as applied to perchlorate, do not support a conclusion that TOR exemption No. 2005-006 is no longer supportable. C. Alleged Disproportionate Impact of Perchlorate on Children's Health and FDA's Obligation Under Executive Order 13045 Executive Order 13045, ``Protection of Children from Environmental Health Risks and Safety Risks'' (see 62 FR 19885, April 23, 1997), provides in part that, ``to the extent permitted by law and appropriate, and consistent with the agency's mission,'' each Federal Agency ``shall ensure that its policies, programs, activities, and standards address disproportionate risks to children that result from environmental health risks or safety risks,'' which are defined as ``risks to health or to safety that are attributable to products or substances that the child is likely to come in contact with or ingest (such as the air we breath [sic], the food we eat, the water we drink or use for recreation, the soil we live on, and the products we use or are exposed to).'' The petition asserted that, because perchlorate has a disproportionate impact on infants, the Executive Order warrants the use by FDA of additional safety factors beyond those provided in Sec. 170.22 (21 CFR 170.22) when considering the safety of the food-contact uses of perchlorate. Specifically, the petition contended that safety factors in addition to the 100-fold safety factor stated in Sec. 170.22 are necessary due to deficiencies in the Lumen et al. BBDR model (discussed in section III.B.1) and because a pregnant woman's short- term exposure to perchlorate can cause irreversible harm to the fetal brain if the woman has low iodine intake. We note that Sec. 170.22 pertains to safety factors used in applying animal experimentation data to man. As the safety arguments presented in the petition utilize data obtained from human subjects, and the petition discusses specific safety factors for each argument, Sec. 170.22 is not relevant to the safety arguments presented in the petition. Furthermore, in the December 5, 2014, submission the petition stated that the tenfold safety factor utilized to derive the RfD for perchlorate is consistent with Executive Order 13045. With respect to the petition's request to apply additional safety factors, section III.B.1 explains that FDA believes the results of the BBDR model are preliminary in nature and not an appropriate basis for a quantitative risk assessment as presented in the petition. A discussion of whether or not uncertainty factors should be applied is premature at this time. For these reasons, we believe that our analysis of the potential health effects of perchlorate satisfies Executive Order 13045 and that the use of additional safety factors is not necessary. D. Request To Issue a New Regulation Under 21 CFR Part 189 Part II of the petition asserted that, if FDA were to revoke TOR exemption No. 2005-006, publication of the notice of revocation in the Federal Register would be insufficient to alert industry, and therefore requested that we issue a new regulation under part 189. The requested regulation would prohibit the use of perchlorates in the manufacture of antistatic agents to be used in food-contact articles, which is the use of perchlorate allowed by TOR exemption No. 2005-006. Because we conclude that TOR exemption No. 2005-006 remains supportable under Sec. 170.39, we decline to propose a regulation under part 189 prohibiting this use of perchlorate. IV. Comments on the Filing Notice We received very few comments on the petition. Those comments that discussed the safety of the use of perchlorate in food contact applications did not provide any additional data to that presented in the petition. In this section we discuss the issues raised in the remaining comments. We preface each comment discussion with a numbered ``Comment'' and each [[Page 20858]] response by the word ``Response'' to make it easier to identify comments and our responses. We have numbered each comment to help distinguish among different topics. The number assigned is for organizational purposes only and does not signify the comment's value, importance, or the order in which it was received. (Comment 1) One comment provided a migration study for sodium perchlorate monohydrate from a worst-case polymeric resin into a dry food simulant. (Response) This study is discussed in section III.A.2. (Comment 2) Several comments stated that the use of potassium perchlorate as an additive in closure-sealing gaskets for food containers has been abandoned. (Response) The abandonment of potassium perchlorate as an additive in closure-sealing gaskets is the subject of a separate food additive petition, 6B4816, which we address elsewhere in this edition of the Federal Register. (Comment 3) Another comment stated that the petition's request that FDA add perchlorate to the list of prohibited substances contained in part 189 is based upon the identification of a hazard relating to a class of chemical substances. The comment asserted that an approach to safety assessment based on hazard identification is a departure from FDA's practice of evaluating the safety of food contact materials based on their intended use. (Response) As we are declining to propose a regulation under part 189 prohibiting the use of perchlorates as a food contact substance in antistatic agents (see section V), it is not necessary to respond to this comment. V. Conclusion We reviewed the petition and with respect to the petition's first request, we have determined that the dietary exposure to sodium perchlorate monohydrate as a result of the use allowed by the TOR exemption No. 2005-006 does not exceed the TOR exemption criteria in Sec. 170.39(a)(2)(i) and that the data and information provided do not support a conclusion that TOR exemption No. 2005-006 is no longer supportable. With respect to the petition's second request, we decline to propose a regulation under part 189 prohibiting the use of perchlorates as a food contact substance in antistatic agents because proposing such a regulation would be inconsistent with our conclusion that the data and information provided in the petition do not support a conclusion that TOR exemption No. 2005-006 is no longer supportable. With respect to the petition's third request, which is the sole request that is the proper subject of a food additive petition, the food additive use of potassium perchlorate has been removed from Sec. 177.1210 in a final rule published elsewhere in this issue of the Federal Register and we decline to address the petitioners' assertions regarding the safety of the food additive use. Therefore, we are denying all three requests, and we are denying the petition in full. VI. Objections Any person that may be adversely affected by this order may file with the Division of Dockets Management (see ADDRESSES) either electronic or written objections. You must separately number each objection, and within each numbered objection you must specify with particularity the provision(s) to which you object, and the grounds for your objection. Within each numbered objection, you must specifically state whether you are requesting a hearing on the particular provision that you specify in that numbered objection. If you do not request a hearing for any particular objection, you waive the right to a hearing on that objection. If you request a hearing, your objection must include a detailed description and analysis of the specific factual information you intend to present in support of the objection in the event that a hearing is held. If you do not include such a description and analysis for any particular objection, you waive the right to a hearing on the objection. It is only necessary to send one set of documents. Identify documents with the docket number found in brackets in the heading of this document. Any objections received in response to the regulation may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov. We will publish notice of the objections that we have received or lack thereof in the Federal Register. As explained in section II.C, only the petition's request to amend Sec. 177.1210 is within the scope of a food additive petition under section 409(b) of the FD&C Act. The remaining two requests are not within the scope of a food additive petition and our denial of these requests is not an order under section 409(c)(1)(B) of the FD&C Act. Therefore, the provision for objections and public hearing under section 409(f) of the FD&C Act does not apply to these two requests. VII. References The following references are on display in the Division of Dockets Management (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. 1. FDA. ``Threshold of Regulation Exemptions.'' Available at https://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/ThresholdRegulationExemptions/default.htm. 2. National Research Council. 2005. ``Health Implications of Perchlorate Ingestion.'' Washington, DC. National Academies Press. ISBN 0-309-09568-9. Available at https://www.nap.edu/catalog/11202/health-implications-of-perchlorate-ingestion. 3. EPA. 2013. ``SAB Advice on Approaches to Derive a Maximum Contaminant Level Goal for Perchlorate.'' EPA-SAB-13-004. Available at https://yosemite.epa.gov/sab%5CSABPRODUCT.NSF/ 86E44EE7F27EEC1A85257B7B0060F364/$File/EPA-SAB-13-004-unsigned2.pdf. 4. Greer, M.A., G. Goodman, R.C. Pleus, et al. 2002. ``Health Effect Assessment for Environmental Perchlorate Contamination: The Dose Response for Inhibition of Thyroidal Radioiodide Uptake in Humans.'' Environmental Health Perspective. 110:927-937. 5. National Institutes of Health, ``Hypothyroidism (Underactive Thyroid).'' Available at https://www.niddk.nih.gov/health-information/endocrine-diseases/hypothyroidism. 6. EPA. ``Perchlorate (ClO4 ) and Perchlorate Salts.'' Available at https://cfpub.epa.gov/ncea/iris2/chemicalLanding.cfm?substance_nmbr=1007. 7. EPA. ``White Paper: Life Stage Considerations and Interpretation of Recent Epidemiological Evidence to Develop a Maximum Contaminant Level Goal for Perchlorate.'' 2012. Available at https:// yosemite.epa.gov/sab/sabproduct.nsf/ d21b76bff879fa0a8525735a00766807/D3BB75D4297CA4698525794300522ACE/ $File/Final+Perchlorate+White+Paper+05.29.12.pdf. 8. Stedman, T.L. 2006. ``Stedman's Medical Dictionary.'' Philadelphia: Lippincott Williams & Wilkins. 28th ed. ISBN 978- 0781733908. 9. FDA. ``Guidance for Industry: Preparation of Premarket Submissions for Food Contact Substances: Chemistry Recommendations.'' Available at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/IngredientsAdditivesGRASPackaging/ucm081818.htm. [[Page 20859]] 10. FDA Memorandum from J. Smith, September 15, 2005. 11. FDA Memorandum from R. Costantino to P. Honigfort, March 31, 2017. 12. FDA. ``Draft Guidance for Industry: Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk.'' December 2016. Available at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm528215.htm. 13. FDA. ``Guidance for Industry: Preparation of Food Contact Notifications for Food Contact Substances: Toxicology Recommendations.'' Available at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm081825.htm. 14. Lumen A., D.R. Mattie, and J.W. Fisher. ``Evaluation of Perturbations in Serum Thyroid Hormones During Human Pregnancy Due to Dietary Iodide and Perchlorate Exposure Using a Biologically Based Dose-Response Model.'' Toxicological Sciences. 133(2):320-41, 2013. 15. FDA Memorandum from G. Patton, P. Honigfort, and J. Aungst to Administrative File, March 31, 2017. 16. Clapp, S., ``FDA Chemist Says Agency's Food Contact Advice is `Showing Its Age.' '' Food Chemicals News. 53(30): 11-12, 2011. Dated: April 28, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-08987 Filed 5-3-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 85 / Thursday, May 4, 2017 / Proposed Rules 20847
DEPARTMENT OF HEALTH AND • Federal eRulemaking Portal: will review this copy, including the
HUMAN SERVICES https://www.regulations.gov. Follow the claimed confidential information, in our
instructions for submitting comments. consideration of comments. The second
Food and Drug Administration Objections submitted electronically, copy, which will have the claimed
including attachments, to https:// confidential information redacted/
21 CFR Parts 170, 177, and 189 www.regulations.gov will be posted to blacked out, will be available for public
[Docket No. FDA–2015–F–0537] the docket unchanged. Because your viewing and posted on https://
objection will be made public, you are www.regulations.gov. Submit both
Natural Resources Defense Council et solely responsible for ensuring that your copies to the Division of Dockets
al.; Denial of Food Additive Petition objection does not include any Management. If you do not wish your
confidential information that you or a name and contact information to be
AGENCY: Food and Drug Administration, third party may not wish to be posted, made publicly available, you can
HHS. such as medical information, your or provide this information on the cover
ACTION: Notification; denial of petition. anyone else’s Social Security number, or sheet and not in the body of your
confidential business information, such comments and you must identify this
SUMMARY: The Food and Drug
as a manufacturing process. Please note information as ‘‘confidential.’’ Any
Administration (FDA, the Agency, or
that if you include your name, contact information marked as ‘‘confidential’’
we) is denying a petition, submitted by
information or other information that will not be disclosed except in
the Natural Resources Defense Council,
identifies you in the body of your accordance with 21 CFR 10.20 and other
Center for Food Safety, Clean Water
objection, that information will be applicable disclosure law. For more
Action, Children’s Environmental
posted on https://www.regulations.gov. information about FDA’s posting of
Health Network, Center for Science in
• If you want to submit a comment comments to public dockets, see 80 FR
the Public Interest, Breast Cancer Fund,
with confidential information that you 56469, September 18, 2015, or access
Center for Environmental Health,
do not wish to be made available to the the information at: https://www.gpo.gov/
Environmental Working Group, and
public, submit the objection as a fdsys/pkg/FR-2015-09-18/pdf/2015-
Improving Kids’ Environment,
written/paper submission and in the 23389.pdf.
requesting that we revoke the Threshold
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
of Regulation (TOR) exemption No.
Submissions’’ and ‘‘Instructions’’). read background documents or
2005–006 to no longer exempt from our
food additive regulations the use of Written/Paper Submissions objections received, go to https://
sodium perchlorate monohydrate as a www.regulations.gov and insert the
Submit written/paper submissions as docket number, found in brackets in the
conductivity enhancer in antistatic follows:
agents for use in finished articles in heading of this document, into the
• Mail/Hand delivery/Courier (for
contact with dry foods; issue a new FDA ‘‘Search’’ box and follow the prompts
written/paper submissions): Division of
regulation to prohibit the use of and/or go to the Division of Dockets
Dockets Management (HFA–305), Food
perchlorates in antistatic agents for use Management, 5630 Fishers Lane, Rm.
and Drug Administration, 5630 Fishers
in food-contact articles; and amend our 1061, Rockville, MD 20852.
Lane, Rm. 1061, Rockville, MD 20852.
food additive regulations to no longer • For written/paper objections FOR FURTHER INFORMATION CONTACT: Hui-
provide for the use of potassium submitted to the Division of Dockets Chen (Anita) Chang, Center for Food
perchlorate as an additive in closure- Management, FDA will post your Safety and Applied Nutrition (HFS–
sealing gaskets for food containers. objection, as well as any attachments, 275), Food and Drug Administration,
DATES: This notification is effective May except for information submitted, 5001 Campus Dr., College Park, MD
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may be stayed by the filing of proper if submitted as detailed in SUPPLEMENTARY INFORMATION:
objections. See Section VI of this ‘‘Instructions.’’
I. Introduction
document for information on the filing Instructions: All submissions received
of objections. Submit either electronic must include the Docket No. FDA– In a document published in the
or written objections and requests for a 2015–F–0537 for ‘‘Natural Resources Federal Register of March 16, 2015 (80
hearing by June 5, 2017. Late, untimely Defense Council et al.; Denial of Food FR 13508), we announced that we filed
filed objections will not be considered. Additive Petition.’’ Received objections, a food additive petition (FAP 4B4808)
The https://www.regulations.gov those filed in a timely manner (see (‘‘petition’’) submitted by the Natural
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at the end of June 5, 2017. Objections ‘‘Confidential Submissions,’’ publically 20005; the Center for Food Safety, 303
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(for written/paper submissions) will be or at the Division of Dockets Francisco, CA 94111; Clean Water
considered timely if they are Management between 9 a.m. and 4 p.m., Action, 144 I St. NW., Suite 400,
postmarked or the delivery service Monday through Friday. Washington, DC 20005; the Center for
acceptance receipt is on or before that • Confidential Submissions—To Science in the Public Interest, 1220 L St.
date. submit an objection with confidential NW., Suite 300, Washington, DC 20005;
information that you do not wish to be Children’s Environmental Health
pmangrum on DSK3GDR082PROD with PROPOSALS
ADDRESSES: You may submit either
electronic or written objections and made publicly available, submit your Network, 110 Maryland Ave. NE., Suite
requests for a hearing identified by objections only as a written/paper 402, Washington, DC 20002; the Breast
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DC 20009; and Improving Kids’ are ionic salts that contain the Commissioner of Food and Drugs (the
Environment, 1915 West 18th St., perchlorate anion (chemical structure Commissioner), on his own initiative or
Indianapolis, IN 46202 (collectively, ClO4¥). In this notification, the term on the petition of any interested person,
‘‘petitioners’’). In the March 2015 ‘‘perchlorates’’ refers to the class of may propose the issuance of a
document, we requested comments on chemicals while the term ‘‘perchlorate’’ regulation amending or repealing a
the petition under § 189.1(c) (21 CFR refers to the perchlorate ion. regulation pertaining to a food additive
189.1(c)). The petition included (see § 171.130(a) (21 CFR 171.130(a))).
submissions dated July 31, 2014, II. Background Our regulation, at § 171.130(b), further
October 15, 2014, and December 5, A. Statutory and Regulatory Background provides that any such petition must
2014. The October 15, 2014, submission include an assertion of facts, supported
The petition asked FDA to take
included a resubmission of the entire by data, showing that new information
actions related to three different types of
July 31, 2014, original petition with the exists with respect to the food additive
FDA regulations.
inclusion of some additional or that new uses have been developed
information. The December 5, 2014, 1. Food Additive Regulation or old uses abandoned, that new data
submission contained additional The Federal Food, Drug, and Cosmetic are available as to toxicity of the
information to that provided in the Act (the FD&C Act) authorizes us to chemical, or that experience with the
October 15, 2014, submission. Any regulate ‘‘food additives’’ (see section existing regulation or exemption may
references to specific parts of the 409(a) of the FD&C Act (21 U.S.C. justify its amendment or repeal.
petition are to the October 15, 2014, FDA has issued administrative
348(a)). The FD&C Act defines ‘‘food
submission while specific references to regulations for food additive petitions in
additive,’’ in relevant part, as any
the December 5, 2014, submission will part 171. These regulations apply to
substance the intended use of which
refer to the date of that document. food additive petitions requesting either
results or may reasonably be expected to that we authorize the new use of a food
The petition asked FDA to take three
separate regulatory actions: (1) Revoke result, directly or indirectly, in its additive or that we amend or repeal an
its 2005 approval of TOR exemption No. becoming a component of food (see existing food additive regulation.
2005–006 allowing as much as 1.2 section 201(s) of the FD&C Act (21
U.S.C. 321(s))). Food additives can 2. TOR Exemption
percent sodium perchlorate
monohydrate in dry food packaging; (2) include both substances added directly The food additive petition process
issue a new § 189.301 (21 CFR 189.301) to food and ‘‘food contact substance[s]’’ generally applies to substances used in
prohibiting the use of perchlorate as a (i.e., substances intended for use in food packaging or processing when the
conductivity enhancer in the materials that come into contact with proposed use will cause the substance
manufacture of antistatic agents to be food, for instance in food packaging or to become part of the food at a level that
used in food contact articles; and (3) manufacturing, but which are not exceeds a minimum ‘‘threshold of
remove potassium perchlorate as an intended to have any technical effect in regulation’’ (see § 170.39 (21 CFR
allowed additive in sealing gaskets for the food (see § 170.3(e)(3) (21 CFR 170.39)). Our determination that a use of
food containers in existing § 177.1210 170.3(e)(3))). Food additives are deemed a substance is at or below the ‘‘threshold
(21 CFR 177.1210). For accuracy, we unsafe and prohibited except to the of regulation’’ is referred to as a
will refer to the petition’s second extent that we approve their use (see, ‘‘threshold of regulation’’ exemption, or
request as a request to issue a new e.g., section 301(a) and (k) (21 U.S.C. a TOR exemption. Regardless of
regulation under part 189 because a 331(a) and (k)) and 409(a) of the FD&C whether the use of a substance is at or
regulation already exists at § 189.301. Act). below the threshold of regulation, we
The petition asserted that the allowed The FD&C Act provides a process reserve the right to apply the food
food-contact uses of perchlorate are not through which persons who wish to use additive petition process in those cases
safe because there is no longer a a food additive may submit a petition in which available information
reasonable certainty that the perchlorate proposing the issuance of a regulation establishes that the proposed food-
is not harmful under the intended prescribing the conditions under which contact use may pose a public health
conditions of use considering: (1) The the additive may be safely used (see risk (see § 170.39(b)).
probable consumption of perchlorate; section 409(b)(1) of the FD&C Act). Such We established the procedures set
(2) the cumulative effect of perchlorate a petition is referred to as a ‘‘food forth in § 170.39 to exempt certain
after taking into account additive petition.’’ When we conclude substances used in food-contact articles
pharmacologically-related substances, that a proposed use of a food additive (e.g., food-packaging (such as a cereal
such as thiocyanate and nitrate, in the is safe, we issue a regulation called a bag) or food-processing equipment) that
diet; and (3) additional safety factors ‘‘food additive regulation’’ authorizing a migrate or may be expected to migrate
necessary to protect the developing specific use of the substance. into food at negligible levels from
brain of fetuses and infants from The specific food additive regulation regulation as a food additive. Eligible
irreversible harm. The petition also at issue in the petition, § 177.1210, lists substances must become a component of
asserted that new exposure data are substances allowed as indirect additives food at levels that are at or below the
available that support the requested (also called food contact substances) in threshold of regulation, must not have
revocation of TOR exemption No. 2005– closures with sealing gaskets for food been shown to cause cancer in humans
006. containers. Potassium perchlorate is one or animals or be suspected carcinogens,
and must meet other criteria in § 170.39.
pmangrum on DSK3GDR082PROD with PROPOSALS
Both food contact substances that are of the listed substances authorized for
the subject of the petition—sodium this use under § 177.1210. If we determine the criteria are met, we
perchlorate monohydrate and potassium The FD&C Act provides that we must inform the requestor by letter that the
perchlorate—belong to a class of by regulation prescribe the procedure by intended use of a substance in food-
chemicals termed ‘‘perchlorates.’’ which a food additive regulation may be contact articles is exempt from
Perchlorates are both naturally- amended or repealed (see section 409(i) regulation as a food additive. Therefore,
occurring and man-made chemicals of the FD&C Act). Our regulation when we issue a TOR exemption, the
with a wide variety of industrial and specific to the administrative actions for intended use of the substance does not
some medical applications. Perchlorates food additives provides that the require a regulation authorizing its food
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petition’s requests to revoke the could induce thyroid hormone changes goal (MCLG) for perchlorate in drinking
approval of TOR exemption No. 2005– to an extent that could ultimately result water. The Safe Drinking Water Act
006 and to issue a new regulation under in neurodevelopmental effects in fetuses defines an MCLG as the level of a
part 189 in this document. However, and infants. The SAB utilized a similar contaminant in drinking water ‘‘at
although we are addressing these MOA framework. In both MOA which no known or anticipated adverse
requests in connection with our denial frameworks, IUI is the determinant, effects on the health of persons occur
of a food additive petition, we non-adverse precursor effect, which and which allows for an adequate
emphasize that these requests are not must occur prior to any later adverse margin of safety.’’ 42 U.S.C. 300g–
the proper subject of a food additive effect. 1(b)(4). An MCLG is a nonenforceable
petition. Our denial of these two public health goal. EPA generally
1. 2005 NRC Review
requests is a final Agency decision, but derives an MCLG using the RfD and
is not an order under section The 2005 NRC report was prepared in specific chemical exposure factors. (Ref.
409(c)(1)(B) of the FD&C Act. response to a request from the EPA that 7). Rather than this default approach,
the National Academy of Sciences the SAB recommended that EPA expand
D. Background on Perchlorate review the science regarding potential existing physiologically-based
Perchlorate can interfere with the adverse effects of disruption of thyroid pharmacokinetic/pharmacodynamics
normal functioning of the thyroid gland function and provide recommendations (PBPK/PD) models to relate perchlorate
by competitively inhibiting the to apply this information to a risk exposure, in combination with iodide
transport of iodide into the thyroid. assessment for environmental intake, beyond IUI to downstream MOA
Iodide is an important component of contamination from perchlorate. The framework effects, such as resultant
two thyroid hormones, T4 and T3, and report recommended that EPA derive a thyroid hormone perturbations and
the transfer of iodide from the blood reference dose (RfD) for perchlorate by potential adverse neurodevelopmental
into the thyroid is an essential step in applying a tenfold intraspecies outcomes. The SAB also recommended
the synthesis of these two hormones. uncertainty factor to a no observed that the sensitive populations for
Iodide transport into the thyroid is effect level (NOEL) based on the exposure to perchlorate that EPA should
mediated by a protein molecule known initiation of IUI as determined in a consider when determining an MCLG
as the sodium (Na∂)-iodide (I¥) human study (Ref. 4). (The RfD is an are the fetuses of hypothyroxinemic
symporter (NIS). NIS molecules bind estimate (with uncertainty spanning pregnant women (hypothyroxinemia
iodide with high affinity, but they also perhaps an order of magnitude) of a means that the free thyroxine (fT4)
bind other ions that have a similar daily oral exposure to the human value is at lower end of the normal
shape and electric charge, such as population (including sensitive range with normal levels of thyroid
perchlorate. The binding of these other subgroups) that is likely to be without stimulating hormone (Ref. 8)) and
ions to the NIS can inhibit iodide an appreciable risk of deleterious effects infants exposed to perchlorate through
transport into the thyroid, which can during a lifetime. The NOEL is an either water-based formula preparations
result in intrathyroidal iodide exposure level at which there are no or the breast milk of lactating women.
deficiency and consequently decreased statistically or biologically significant
synthesis of T4 and T3 (73 FR 60262, increases in frequency or severity of any III. Review of the Petition
60266, October 10, 2008). In fetuses, effect between the exposed population The petition asserted that the original
infants, and young children, thyroid and its appropriate control.) The NRC request for TOR exemption No. 2005–
hormones are critical for normal growth stated that this approach was 006 contained errors that should have
and development. Id. at 60275. For conservative and protective of health made the request ineligible for a TOR
example, sustained thyroid hormone given that the NOEL is based on the exemption under § 170.39. The petition
decrement in a pregnant mother could non-adverse effect of IUI, which also asserted that we made additional
lead to adverse neurodevelopmental precedes the continuum of possible errors in exempting the proposed use of
effects in the fetus. Id. at 60266. adverse effects as a result of perchlorate sodium perchlorate monohydrate from
Research in this area is ongoing. exposure. According to the NRC, the regulation as a food additive. The
As part of its discussion asserting that application of the uncertainty factor petition also identified four categories of
new information is available that raises accounts for differences in sensitivity ‘‘significant new information that raises
question as to the safety of the allowed between the healthy human subjects of questions about the dietary
food-contact uses of perchlorates, the the determinant clinical study and concentration or the safety of a
petition cited two reviews on ‘‘even the most sensitive populations’’ substance that [FDA] has exempted from
perchlorate requested by the for perchlorate exposure, which the regulation,’’ that it contends warrant
Environmental Protection Agency NRC identified as fetuses of pregnant reevaluation of TOR exemption No.
(EPA): A 2005 National Research women who may have hypothyroidism 2005–006 under § 170.39(g). Lastly, the
Council (NRC) review (Ref. 2) and the or iodide deficiency. (Hypothyroidism petition asserted that infants are likely
2013 report of the EPA’s Scientific is a condition where ‘‘the thyroid gland to be disproportionately impacted by
Advisory Board (SAB) (Ref. 3). The 2005 does not produce enough thyroid perchlorate, and that we have an
NRC report noted that thyroid iodide hormones to meet the body’s needs’’ obligation under Executive Order 13045
uptake inhibition (IUI) is the only effect (Ref. 5)). EPA adopted the NRC’s (see 62 FR 19885, April 23, 1997) to
that has been consistently documented recommendations resulting in an RfD of address risks to infants from perchlorate
pmangrum on DSK3GDR082PROD with PROPOSALS
in humans exposed to perchlorate. 0.7 micrograms perchlorate/kilogram exposure. The petition also requested
Therefore, as part of its review, the NRC body weight/day (mg/kg bw/d) (Ref. 6). that FDA issue a new regulation under
utilized a hypothetical mode-of-action part 189 to prohibit the use of
(MOA) framework, which represents a 2. 2013 EPA SAB Report perchlorate as a conductivity enhancer
continuum of possible biological effects The 2013 SAB report was developed in the manufacture of antistatic agents
resulting from perchlorate exposure, to in response to a request by EPA for to be ‘‘applied to food contact articles.’’
describe the potential pathway of events guidance on a suitable approach to We will first address the petition’s
following perchlorate exposure. This utilize relevant available information to arguments regarding the review of TOR
MOA framework hypothesized that IUI derive a maximum contaminant level exemption No. 2005–006, then address
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![Federal Register / Vol. 82, No. 85 / Thursday, May 4, 2017 / Proposed Rules 20857
perchlorate as a result of TOR acknowledged potential flaws in the 50 necessary due to deficiencies in the
exemption No. 2005–006 as determined ppb migration concentration Lumen et al. BBDR model (discussed in
by Ciba (0.063 mg per chlorate/person/ assumption for migration to non-fatty, section III.B.1) and because a pregnant
day, which equates to 0.001 mg/kg dry foods (Food Type VIII). To support woman’s short-term exposure to
bodyweight/day utilizing FDA’s this statement, the petition cited a 2011 perchlorate can cause irreversible harm
assumption of 60 kg bodyweight for article which summarizes the speech to the fetal brain if the woman has low
adults as described in the chemistry given by the FDA scientist (Ref. 16). The iodine intake.
guidance), as well as the exposures petition also asserted that the 50 ppb We note that § 170.22 pertains to
determined from the migration study migration assumption is particularly safety factors used in applying animal
discussed in section II.A.2 (for adults: flawed for perchlorate, which is used in experimentation data to man. As the
0.075 mg/person/day which equates to packaging to neutralize the static charge safety arguments presented in the
0.001 mg/kg bodyweight/day; and for on dry food. petition utilize data obtained from
infants: 0.019 mg/kilogram bodyweight/ The migration study provided in human subjects, and the petition
day—see section II.A.4). Therefore, even comments submitted to the docket for discusses specific safety factors for each
if deriving a risk assessment value based the petition (discussed in section argument, § 170.22 is not relevant to the
on the results presented in the Lumen III.A.2.a) found that perchlorate safety arguments presented in the
et al. article were appropriate, the migrated into a simulant for non-fatty, petition. Furthermore, in the December
exposure to perchlorate as a result of dry foods at a concentration of 0.5 ng 5, 2014, submission the petition stated
TOR exemption No. 2005–006 is lower perchlorate/g food, or 0.5 ppb. As noted, that the tenfold safety factor utilized to
than the resulting risk assessment value, this value is substantially less than the derive the RfD for perchlorate is
and therefore would not support the 50 ppb migration concentration consistent with Executive Order 13045.
assertion by the petitioners that the assumption provided in our chemistry With respect to the petition’s request
results presented in the Lumen et al. guidance and indicates that the 50 ppb to apply additional safety factors,
article ‘‘raises questions about the safe migration concentration assumption section III.B.1 explains that FDA
level of exposure to perchlorate relied does not understate migration from the believes the results of the BBDR model
on by Ciba when the Agency approved intended use of sodium perchlorate are preliminary in nature and not an
TOR No. 2005–006.’’ monohydrate into non-fatty, dry foods. appropriate basis for a quantitative risk
As a result, the petition’s contentions assessment as presented in the petition.
2. Argument Related to Cumulative regarding alleged flaws in the 50 ppb A discussion of whether or not
Dietary Exposure From Perchlorate, and migration concentration assumption,
Substances Pharmacologically Related uncertainty factors should be applied is
both generally and as applied to premature at this time. For these
to Perchlorate, in the Food Supply perchlorate, do not support a conclusion reasons, we believe that our analysis of
The petition asserted that new that TOR exemption No. 2005–006 is no the potential health effects of
information has become available, since longer supportable. perchlorate satisfies Executive Order
FDA issued the listing regulation for 13045 and that the use of additional
potassium perchlorate in § 177.1210 and C. Alleged Disproportionate Impact of
Perchlorate on Children’s Health and safety factors is not necessary.
TOR exemption No. 2005–006, that
nitrate and thiocyanate are FDA’s Obligation Under Executive D. Request To Issue a New Regulation
pharmacologically related to Order 13045 Under 21 CFR Part 189
perchlorate, and that perchlorate Executive Order 13045, ‘‘Protection of Part II of the petition asserted that, if
contamination of the food supply is Children from Environmental Health FDA were to revoke TOR exemption No.
widespread. The petition also asserted Risks and Safety Risks’’ (see 62 FR 2005–006, publication of the notice of
that we are required to take into account 19885, April 23, 1997), provides in part revocation in the Federal Register
the cumulative effect of these that, ‘‘to the extent permitted by law would be insufficient to alert industry,
substances in the diet. and appropriate, and consistent with the and therefore requested that we issue a
As discussed in section III.A.5, under agency’s mission,’’ each Federal Agency new regulation under part 189. The
§ 170.39(a)(2)(i), we do not calculate ‘‘shall ensure that its policies, programs, requested regulation would prohibit the
cumulative dietary exposure to a activities, and standards address use of perchlorates in the manufacture
substance or pharmacologically related disproportionate risks to children that of antistatic agents to be used in food-
substances in evaluating whether the result from environmental health risks contact articles, which is the use of
use of the substance qualifies for a TOR or safety risks,’’ which are defined as perchlorate allowed by TOR exemption
exemption from regulation as a food ‘‘risks to health or to safety that are No. 2005–006.
additive. Under § 170.39(a)(2)(i), the attributable to products or substances Because we conclude that TOR
only dietary exposure that is relevant to that the child is likely to come in exemption No. 2005–006 remains
whether the use of a substance qualifies contact with or ingest (such as the air supportable under § 170.39, we decline
for a TOR exemption from regulation as we breath [sic], the food we eat, the to propose a regulation under part 189
a food additive is the dietary exposure water we drink or use for recreation, the prohibiting this use of perchlorate.
resulting from the use in question. soil we live on, and the products we use
Therefore, the petition’s argument or are exposed to).’’ The petition IV. Comments on the Filing Notice
regarding cumulative dietary exposure asserted that, because perchlorate has a We received very few comments on
disproportionate impact on infants, the
pmangrum on DSK3GDR082PROD with PROPOSALS
to perchlorate or pharmacologically the petition. Those comments that
related substances does not support a Executive Order warrants the use by discussed the safety of the use of
conclusion that TOR exemption No. FDA of additional safety factors beyond perchlorate in food contact applications
2005–006 is no longer supportable. those provided in § 170.22 (21 CFR did not provide any additional data to
170.22) when considering the safety of that presented in the petition.
3. Alleged Flaws in FDA’s 50 ppb the food-contact uses of perchlorate. In this section we discuss the issues
Migration Concentration Assumption Specifically, the petition contended that raised in the remaining comments. We
The petition stated that FDA, in a safety factors in addition to the 100-fold preface each comment discussion with
2011 speech by an FDA scientist, safety factor stated in § 170.22 are a numbered ‘‘Comment’’ and each
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![Federal Register / Vol. 82, No. 85 / Thursday, May 4, 2017 / Proposed Rules 20859
10. FDA Memorandum from J. Smith, the St. Johns River. This action is hazardous condition for all vessels
September 15, 2005. necessary to ensure the safety and transiting in and out of the Port of
11. FDA Memorandum from R. Costantino to efficiency of navigation for all vessels Jacksonville. These conditions may
P. Honigfort, March 31, 2017. transiting in and out of the Port of worsen with the expected growth in the
12. FDA. ‘‘Draft Guidance for Industry:
Preparation of Food Contact
Jacksonville. We invite your comments number of vessels, and the likelihood of
Notifications for Food Contact on this proposed rulemaking. large vessels calling on Jacksonville in
Substances in Contact with Infant DATES: Comments and related material the near future.
Formula and/or Human Milk.’’ December must be received by the Coast Guard on In 2013, Coast Guard Sector
2016. Available at https://www.fda.gov/ or before June 5, 2017. Jacksonville hosted a meeting to discuss
Food/GuidanceRegulation/
ADDRESSES: You may submit comments
the establishment of a commercial
GuidanceDocuments anchorage off the entrance to the St.
RegulatoryInformation/ucm528215.htm. identified by docket number USCG–
2016–0897 using the Federal Johns River. Members from SJBPA,
13. FDA. ‘‘Guidance for Industry: Preparation JMTX, Jacksonville Port Authority,
of Food Contact Notifications for Food eRulemaking Portal at http://
www.regulations.gov. See the ‘‘Public Florida Docking Masters, Army Corp of
Contact Substances: Toxicology
Recommendations.’’ Available at https:// Participation and Request for Engineers, NOAA, local tug companies,
www.fda.gov/Food/GuidanceRegulation/ Comments’’ portion of the and the local Shrimp Producers
GuidanceDocuments SUPPLEMENTARY INFORMATION section for
Association all provided input to the
RegulatoryInformation/ucm081825.htm. further instructions on submitting proposed anchorage outlined in this
14. Lumen A., D.R. Mattie, and J.W. Fisher.
comments. notice. Additionally, in April 2016,
‘‘Evaluation of Perturbations in Serum Coast Guard Sector Jacksonville
Thyroid Hormones During Human FOR FURTHER INFORMATION CONTACT: If conducted a focused Waterways
Pregnancy Due to Dietary Iodide and you have questions about this proposed Analysis and Management System
Perchlorate Exposure Using a rulemaking, call or email Lieutenant (WAMS) study for the proposed offshore
Biologically Based Dose-Response Allan Storm, Sector Jacksonville,
Model.’’ Toxicological Sciences. anchorage area. No additional findings
Waterways Management Division, U.S. were found and no comments of
133(2):320–41, 2013.
15. FDA Memorandum from G. Patton, P. Coast Guard; telephone 904–714–7616, concern were received from this WAMS
Honigfort, and J. Aungst to email Allan.H.Storm@uscg.mil. study.
Administrative File, March 31, 2017. SUPPLEMENTARY INFORMATION: The Coast Guard proposes this
16. Clapp, S., ‘‘FDA Chemist Says Agency’s rulemaking under authority in 33 U.S.C.
Food Contact Advice is ‘Showing Its I. Table of Abbreviations 471, 1221 through 1236, 2071; 33 CFR
Age.’ ’’ Food Chemicals News. 53(30): CFR Code of Federal Regulations 1.05–1; Department of Homeland
11–12, 2011. DHS Department of Homeland Security Security Delegation No. 0170.1.
Dated: April 28, 2017. FR Federal Register
NPRM Notice of proposed rulemaking III. Discussion of Proposed Rule
Anna K. Abram,
§ Section The Coast Guard proposes to amend
Deputy Commissioner for Policy, Planning, U.S.C. United States Code
Legislation, and Analysis. its anchorage regulations to establish an
[FR Doc. 2017–08987 Filed 5–3–17; 8:45 am] II. Background, Purpose, and Legal offshore anchorage area approximately
Basis seven nautical miles northeast of the St.
BILLING CODE 4164–01–P
Johns River inlet, Florida. There
The Coast Guard, with the currently is not a dedicated deep draft
recommendation from the St. Johns Bar offshore anchorage for commercial
DEPARTMENT OF HOMELAND Pilot Association (SJBPA) and ocean-going vessels arriving at the port
SECURITY Jacksonville Marine Transportation of Jacksonville. This action is necessary
Exchange (JMTX) Harbor Safety to ensure the safety and efficiency of
Coast Guard Committee, developed the dedicated navigation for all vessels transiting in
offshore anchorage area approximately 7 and out of the Port of Jacksonville. The
33 CFR Part 110 nautical miles northeast of the St. Johns anchorage area’s dimensions are
[Docket Number USCG–2016–0897] River inlet, Florida proposed in this approximately three nautical miles by
notice of proposed rulemaking (NPRM). two nautical miles and would
RIN 1625–AA01 The purpose of this proposed encompass approximately six square
rulemaking is to improve the nautical miles.
Anchorage Ground; Atlantic Ocean,
navigational safety, traffic management The anchorage boundaries are
Jacksonville, FL
and port security for the Port of described, using precise coordinates, in
AGENCY: Coast Guard, DHS. Jacksonville. the proposed regulatory text at the end
ACTION: Notice of proposed rulemaking. Currently, there is not a dedicated of this notice.
deep draft offshore anchorage for
SUMMARY: The Coast Guard proposes to commercial ocean-going vessels arriving IV. Regulatory Analyses
amend its anchorage regulations to at the port of Jacksonville. Vessels have We developed this proposed rule after
establish a new offshore anchorage area routinely been recommended to anchor considering numerous statutes and
approximately 7 nautical miles 11⁄2 nautical miles northeast of the Executive orders related to rulemaking.
pmangrum on DSK3GDR082PROD with PROPOSALS
northeast of the St. Johns River inlet, ‘‘STJ’’ entrance buoy. However, many Below we summarize our analyses
Florida. Currently, there is not a mariners are hesitant to anchor in this based on a number of these statutes and
dedicated deep draft offshore anchorage location due to its proximity to the Executive Orders.
for commercial ocean-going vessels charted danger area, which is related to
arriving at the Port of Jacksonville. unexploded ordinances on the sea floor. A. Regulatory Planning and Review
Establishing an adequate and dedicated Without a designated charted anchorage Executive Orders 12866 (Regulatory
offshore anchorage will alleviate area, many vessels end up drifting or Planning and Review) and 13563
hazardous conditions with vessels anchoring in the common approaches to (Improving Regulation and Regulatory
anchoring in the common approaches to the St. Johns River, creating a potential Review) direct agencies to assess the
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Document Created: 2017-05-04 01:49:11
Document Modified: 2017-05-04 01:49:11
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Notification; denial of petition. | |
| Dates | This notification is effective May 4, 2017; except as to any provisions that may be stayed by the filing of proper objections. See Section VI of this document for information on the filing of objections. Submit either electronic or written objections and requests for a hearing by June 5, 2017. Late, untimely filed objections will not be considered. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of June 5, 2017. Objections received by mail/hand delivery/courier (for written/ paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. | |
| Contact | Hui-Chen (Anita) Chang, Center for Food Safety and Applied Nutrition (HFS-275), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740-3835, 240-402- 1161. | |
| FR Citation | 82 FR 20847 | |
| CFR Citation | 21
CFR
170 21 CFR 177 21 CFR 189 |
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