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Federal Register / Vol. 86, No. 193 / Friday, October 8, 2021 / Rules and Regulations Objection 11: Combe objects to FDAs argument that the absorption percentage from the Moore study is invalid because it tested only a small patch of skin.
Objection 12: Combe objects to FDAs reliance on a permeability coefficient for lead instead of fractional absorption.
Objection 13: Combe objects to FDAs use of a permeability coefficient for lead acetate that EPA repudiated and replaced with a much lower estimate.
Objection 14: Combe objects to FDAs conclusion that lower median lead levels in blood since 1990 means that any lead contributed by lead acetate is less safe now.
Objection 15: Combe objects to FDAs entire analysis because it is missing two critical linksFDA never relates exposure from lead acetate to any change in blood levels, and thus it never relates it to any predicted harm.
Objection 16: Combe objects to FDAs whole argument as FDA never links exposure to lead from lead acetate to a change in steady-state blood levels.
Objection 17: Combe objects to FDAs conclusion about the effect of lead acetate on blood lead levels.
Objection 18: Combe objects to FDA taking a zero-tolerance approach for lead.
Objection 19: Combe objects to FDAs failure to consider reducing the permitted lead acetate level under 73.2396 from 0.6
percent to 0.153 percent.

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See Submission from Anthony M.
Santini, Senior Vice President and General Counsel, Combe Inc., Peter Barton Hutt, Matthew J. Hegreness, and Richard F. Kingham, Covington &
Burling LLP Counsel for Combe Incorporated, to the Dockets Management Staff, FDA, dated November 30, 2018, at pages 2558, available at: https
www.regulations.gov/document/FDA2017-C-1951-0233 referred to as the Submission.
III. Standards for Granting a Hearing Specific criteria for deciding whether to grant or deny a request for a hearing are set out in 12.24b. Under that regulation, a hearing will be granted if the material submitted by the requester shows, among other things, that: 1
There is a genuine and substantial factual issue for resolution at a hearing a hearing will not be granted on issues of policy or law; 2 the factual issue can be resolved by available and specifically identified reliable evidence a hearing will not be granted on the basis of mere allegations or denials or general descriptions of positions and contentions; 3 the data and information submitted, if established at a hearing, would be adequate to justify resolution of the factual issue in the way sought by the requester a hearing will be denied if the data and information submitted are insufficient to justify the factual determination urged, even if
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accurate; 4 resolution of the factual issue in the way sought by the person is adequate to justify the action requested a hearing will not be granted on factual issues that are not determinative with respect to the action requested, e.g., if the action would be the same even if the factual issue were resolved in the way sought; 5 the action requested is not inconsistent with any provision in the FD&C Act or any regulation particularizing statutory standards the proper procedure in those circumstances is for the person requesting the hearing to petition for an amendment or waiver of the regulation involved; and 6 the requirements in other applicable regulations, e.g., 21
CFR 10.20, 12.21, 12.22, 314.200, 514.200, and 601.7a, and in the notice issuing the final regulation or the notice of opportunity for a hearing are met.
A party seeking a hearing must meet a threshold burden of tendering evidence suggesting the need for a hearing Costle v. Pacific Legal Foundation, 445 U.S. 198, 214215
1980, citing Weinberger v. Hynson, Westcott & Dunning, Inc, 412 U.S. 609, 620621 1973. An allegation that a hearing is necessary to sharpen the issues or to fully develop the facts does not meet this test Georgia Pacific Corp. v. EPA, 671 F.2d 1235, 1241 9th Cir. 1982. If a hearing request fails to identify any factual evidence that would be the subject of a hearing, there is no point in holding one. In judicial proceedings, a court is authorized to issue summary judgment without an evidentiary hearing whenever it finds that there are no genuine issues of material fact in dispute, and a party is entitled to judgement as a matter of law see Rule 56, Federal Rules of Civil Procedure. The same principle applies to administrative proceedings see 21
CFR 12.28.
A hearing request must not only contain evidence, but that evidence should raise a material issue of fact concerning which a meaningful hearing might be held Pineapple Growers Assn v. FDA, 673 F.2d 1083, 1085 9th Cir. 1982. Where the issues raised in the objection are, even if true, legally insufficient to alter the decision, an Agency need not grant a hearing see Dyestuffs and Chemicals, Inc. v.
Flemming, 271 F.2d 281, 286 8th Cir.
1959. A hearing is justified only if the objections are made in good faith and if they draw in question in a material way the underpinnings of the regulation at issue Pactra Industries v. CPSC, 555
F.2d 677, 684 9th Cir. 1977. A hearing need not be held to resolve questions of law and policy see Citizens for Allegan County, Inc. v. FPC, 414 F.2d 1125, 1128

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D.C. Cir. 1969; Sun Oil Co. v. FPC, 256
F.2d 233, 240 5th Cir. 1958.
Even if the objections raise material issues of fact, we need not grant a hearing if those same issues were adequately raised and considered in an earlier proceeding. Once an issue has been so raised and considered, a party is estopped from raising that same issue in a later proceeding without new evidence. The various judicial doctrines dealing with finality, such as collateral estoppel, can be validly applied to the administrative process see Pacific Seafarers, Inc. v. Pac. Far East Line, Inc., 404 F.2d 804, 809 D.C. Cir. 1968, cert. denied, 393 U.S. 1093 1969. In explaining why these principles ought to apply to an Agency proceeding, the U.S. Court of Appeals for the District of Columbia Circuit wrote: The underlying concept is as simple as this:
justice requires that a party have a fair chance to present his position. But overall interests of administration do not require or generally contemplate that he will be given more than a fair opportunity Retail Clerks Union, Local 1401 v. NLRB, 463 F.2d 316, 322 D.C.
Cir. 1972; see also Costle v. Pacific Legal Foundation, 445 U.S. 198 at 215
17.
IV. Analysis of Objections and Response to Hearing Requests The submission from Combe contains 19 numbered objections, and Combe requests a hearing on each of them. We address each objection below, as well as the evidence and information filed in support of each, comparing each objection and the information submitted in support of it to the standards for granting a hearing in 12.24b. For purposes of clarity, we have grouped the numbered objections into categories of related subjects while maintaining the objection numbers assigned by Combe.
A. Category A: No Known Safe Level of Lead Exposure Combes numbered objections included in Category A are as follows:
1. Combe objects to FDAs finding that there is no safe level of exposure for lead.
2. Combe objects to FDAs reliance on information about lead exposure in children e.g., recommendations from the CDC.
4. Combe objects to the conclusions FDA
draws from JECFA 2011.
5. Combe objects to FDAs reliance on EPAs goals for lead in drinking water.
18. Combe objects to FDA taking a zerotolerance approach to lead.

Objection 1. Combe objects to FDAs finding that there is no safe level of exposure for lead. The objection asserts that, . . . the weight of the scientific evidence demonstrates that low levels of
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