[Federal Register Volume 86, Number 193 (Friday, October 8, 2021)]
[Rules and Regulations]
[Pages 56183-56195]
[FR Doc No: 2021-21892]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2017-C-1951]

Termination of Listing of Color Additives Exempt From
Certification; Lead Acetate

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; response to objections and denial of public hearing
requests; removal of administrative stay.

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SUMMARY: The Food and Drug Administration (FDA or we) is responding to
objections and a public hearing request that we received from Combe
Inc., on the final rule entitled ``Termination of Listing of Color
Additives Exempt From Certification; Lead Acetate,'' which published on
October 31, 2018. The final rule amended the color additive regulations
to no longer provide for the safe use of lead acetate in cosmetics
intended for coloring hair on the scalp. After reviewing the
objections, we have concluded that the objections do not raise issues
of material fact that justify a hearing. Therefore, the stay of the
effectiveness for the repeal and delisting of the color additive
regulation is now lifted, and we are amending the color additive
regulations to no longer provide for the safe use of lead acetate in
cosmetics intended for coloring hair on the scalp.

DATES: This rule is effective January 6, 2022.

ADDRESSES: For access to the docket to read background documents or
comments 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 Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
240-402-7500.

FOR FURTHER INFORMATION CONTACT: Shayla West-Barnette, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 31, 2018 (83 FR 54665), we
issued a final rule repealing the color additive regulation in Sec.
73.2396 (21 CFR 73.2396) to no longer provide for the safe use of lead
acetate in cosmetics intended for coloring hair on the scalp because
new data available since lead acetate was permanently listed have
demonstrated that there is no longer a reasonable certainty that no
harm will result from the use of this color additive. We gave
interested persons until November 30, 2018, to file objections and
requests for a hearing on the final rule. The preamble to the final
rule stated that the effective date of the final rule would be on
December 3, 2018, except as to any provisions that may be stayed by the
filing of proper objections (83 FR 54665 at 54673). On December 3,
2018, Sec.  73.2396 was removed from the CFR. However, we had received
objections and requests for a hearing on the objections from Combe Inc.
(Combe), a manufacturer of hair dyes containing lead acetate. Under
sections 701(e)(2) and 721(d) of the FD&C Act (21 U.S.C. 371(e)(2) and
379e(d)), the filing of objections operates to stay the effectiveness
of our repeal until we take final action on the objections.
    To implement a stay of effectiveness as required by sections
701(e)(2) and 721(d) of the FD&C Act, we published a final rule in the
Federal Register of April 1, 2019 (84 FR 12081), reinstating Sec.
73.2396 pending final FDA action on the objections to the October 31,
2018, final rule. We also stated that this action did not reflect any
change in our determination that new data demonstrate that there is no
longer a reasonable certainty of no harm from the use of this color
additive.
    FDA listed lead acetate in Sec.  73.2396 in 1980 as a color
additive for safe use in cosmetics intended for coloring hair on the
scalp, subject to certain restrictions and labeling requirements, at
levels up to 0.6 percent (weight to volume; equivalent to 6,000 parts
per million (ppm)) lead in the cosmetic product (45 FR 72112). Lead
acetate is used in progressive hair dyes that, when applied to gray
hair, gradually change the color with repeated applications.\1\
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    \1\ For example, as indicated in a lead acetate-containing
progressive hair dye product manufacturer's use direction (Ref. 10),
after the initial application, users might apply the progressive
hair dye daily until the desired color shade is achieved, and once
or twice per week to maintain the hair color thereafter.
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II. Objections and Requests for a Hearing

    Sections 701(e)(2) and 721(d) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) collectively provide that, within 30 days after
publication of an order relating to a color additive regulation, any
person adversely affected by such an order may file objections,
specifying with particularity the provisions of the order deemed
objectionable, stating the grounds therefor, and requesting a public
hearing upon such objections. We may deny a hearing request if the
objections to the regulation do not raise genuine and substantial
issues of fact that can be resolved at a hearing (Sec.  12.24(b)(1) (21
CFR 12.24(b)(1)). (See also Community Nutrition Institute v. Young, 773
F.2d 1356, 1364 (D.C. Cir. 1985).)
    Objections and requests for a hearing are governed by 21 CFR part
12 of our regulations. Under 21 CFR 12.22(a), each objection must meet
the following conditions: (1) Must be submitted on or before the 30th
day after the date of publication of the final rule; (2) must be
separately numbered; (3) must specify with particularity the provision
of the regulation or proposed order objected to; (4) must specifically
state the provision of the regulation or proposed order on which a
hearing is requested (failure to request a hearing on an objection
constitutes a waiver of the right to a hearing on that objection); and
(5) must include a detailed description and analysis of the factual
information to be presented in support of the objection if a hearing is
requested (failure to include a description and analysis for an
objection constitutes a waiver of the right to a hearing on that
objection).
    Following publication of the final rule repealing the regulation in
Sec.  73.2396 to no longer provide for the safe use of lead acetate in
cosmetics intended for coloring hair on the scalp, we received a
submission from Combe, a manufacturer of hair dyes containing lead
acetate, providing 19 objections and requesting a hearing on each of
the objections. Combe provided the following numbered objections:

    Objection 1: Combe objects to FDA's finding that there is no
safe level of exposure for lead.
    Objection 2: Combe objects to FDA's reliance on information
about lead exposure in children (e.g., recommendations from the
Centers for Disease Control and Prevention (CDC)).
    Objection 3: Combe objects to FDA's reliance on sources that
discuss blood level of lead, not exposure levels (see, e.g.,
National Toxicology Program (NTP) monograph).
    Objection 4: Combe objects to the conclusions FDA draws from the
Joint Food and Agriculture Organization/World Health Organization
(FAO/WHO) Expert Committee on Food Additives (JECFA) (2011).
    Objection 5: Combe objects to FDA's reliance on the
Environmental Protection Agency's (EPA's) goals for lead in drinking
water.
    Objection 6: Combe objects to FDA's conclusion that the 1980
Moore et al. study (Ref. 1, the Moore study) underestimated the
exposure of lead.
    Objection 7: Combe objects to FDA's criticisms of Moore.
    Objection 8: Combe objects to FDA's finding that the lead in the
Moore study could have been absorbed by other parts of the body than
the blood.
    Objection 9: Combe objects to FDA's reliance on a novel and
unvalidated computer model.
    Objection 10: Combe objects to FDA's treating an unvalidated
computer model as more reliable than robust human data.

    Objection 11: Combe objects to FDA's 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 FDA's reliance on a
``permeability coefficient'' for lead instead of fractional
absorption.
    Objection 13: Combe objects to FDA's use of a permeability
coefficient for lead acetate that EPA repudiated and replaced with a
much lower estimate.
    Objection 14: Combe objects to FDA's 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 FDA's entire analysis because it
is missing two critical links--FDA 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 FDA's 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 FDA's 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 FDA's failure to consider
reducing the permitted lead acetate level under Sec.  73.2396 from
0.6 percent to 0.153 percent.

    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 25-58, available at: https://www.regulations.gov/document/FDA-2017-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 Sec.  12.24(b). 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 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
601.7(a), 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, 214-215 (1980), citing
Weinberger v. Hynson, Westcott & Dunning, Inc, 412 U.S. 609, 620-621
(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 Ass'n 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 (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 Sec.  12.24(b). 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

    Combe's numbered objections included in Category A are as follows:

    1. Combe objects to FDA's finding that there is no safe level of
exposure for lead.
    2. Combe objects to FDA's 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 FDA's reliance on EPA's goals for lead in
drinking water.
    18. Combe objects to FDA taking a zero-tolerance approach to
lead.

    Objection 1. Combe objects to ``FDA's 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

lead are safe, especially for the population that uses hair dye
containing lead acetate--older men with graying hair.'' See Submission,
page 26.
    (Response to Objection 1) Our determination that a color additive
is safe means that there is convincing evidence that establishes with
reasonable certainty that no harm will result from the intended use of
the color additive (Sec.  70.3(i)). The regulation in Sec.  73.2396
permits the use of lead acetate (calculated as lead) at levels not to
exceed 0.6 percent (6,000 parts per million (ppm; milligrams/kilograms
(mg/kg))) as a color additive in cosmetics intended for coloring hair
on the scalp. Combe did not provide scientific data to support its
objection or to demonstrate that there is a level of exposure to lead
that could be considered safe.
    Following our full evaluation of data submitted in color additive
petition (CAP) 7C0309 requesting repeal of Sec.  73.2396 and other
pertinent data and information (see September 18, 2018, memorandum from
M.K. Wyatt to M. Harry, ``the Wyatt Memorandum'' (Ref. 2)), we have
determined that there is no known level of exposure to lead that does
not produce adverse effects. While Combe states that ``. . . lead does
not pose a danger to adults at low levels . . .,'' Combe failed to
provide in this objection the specific levels at which lead does not
pose a danger to adults and any corresponding scientific evidence to
support this statement. See Submission, page 27.
    The objection failed to include new data or information that would
refute our findings about the lack of a safe level of lead exposure.
The objection merely alleges that low levels of lead are safe, without
providing any scientific basis. A hearing will not be granted on the
basis of mere allegations or general descriptions of positions and
contentions (Sec.  12.24(b)(2)). The objector must, at a minimum, raise
a genuine and substantial issue of fact for resolution at a hearing.
Therefore, we are denying the request for a hearing on this objection.
    Objection 2. Combe objects to ``FDA's reliance on information about
lead exposure in children (e.g., recommendations from the CDC).'' In
this objection, ``Combe does not dispute the fact that lead exposure
can harm a developing child,'' but states that this fact has ``no
bearing on the use of lead acetate in a progressive hair dye for older
men.'' See Submission, page 27. Combe also asserts that ``lead poses no
danger at low levels to older adults.'' See Submission, page 28.
    (Response to Objection 2) We acknowledge that Combe's products
(i.e., lead acetate-containing progressive hair dyes) are intended for
use by adults and not by children. Our decision to repeal the
regulation is based on the evidence of lead-related adverse health
effects reported at low levels of lead in adults, such as adverse
cardiovascular and kidney effects, cognitive dysfunction, and adverse
reproductive outcomes (Ref. 3), and the lack of evidence of a safe
level of exposure for lead. Currently, available data and information
do not support the safe use of lead acetate intentionally added to
cosmetics for coloring hair on the scalp of any age group or gender.
Therefore, the use of lead acetate as a color additive no longer meets
the safety standard of ``reasonable certainty of no harm.''
    We also note that we did not rely on the toxicity information about
lead exposure in children; rather, in the final rule, we referred to
the CDC statement that there is no safe blood lead level in children to
further demonstrate the risks of lead exposure and why there is a U.S.
Government-wide effort to limit lead exposure to the public. We
continue to work to limit consumers' exposure to lead in all FDA-
regulated products, including cosmetics.
    Combe failed to provide scientific data and information
demonstrating that there is a safe level of lead exposure from the
listed use of lead acetate as a color additive. A hearing will not be
granted on the basis of mere allegations or general descriptions of
positions and contentions (Sec.  12.24(b)(2)). The objector must, at a
minimum, raise a genuine and substantial issue of fact for resolution
at a hearing. Therefore, we are denying the request for a hearing on
this objection.
    Objection 4. Combe objects to ``the conclusions FDA draws from
JECFA (2011).'' See Submission, page 32. In this objection, Combe cites
JECFA's conclusion that ``it could not establish a new provisional
tolerable weekly intake (PTWI) that would be considered health
protective,'' and that JECFA instead established a ``negligible risk''
level for food. See Submission, at page 32. Combe alleges that ``FDA
did not analyze the underlying scientific discussion in JECFA (2011).''
See Submission, page 32.
    (Response to Objection 4) JECFA stated that ``because the dose-
response analyses do not provide any indication of a threshold for the
key effects of lead, the Committee therefore concluded that ``it was
not possible to establish a new PTWI that would be considered to be
health protective'' (Ref. 4). Notably, JECFA's statement about
``negligible risk'' was within the context of unavoidable lead exposure
as an impurity in food, instead of intentionally added, avoidable
exposures to lead in a cosmetic product. We are not aware of any
statement by a competent, national regulatory authority or an
international risk assessment body establishing a safe level of lead
exposure that would support a determination that there is a reasonable
certainty of no harm from the use of lead acetate as a color additive
in hair dye. Instead, for example, the WHO has stated that ``[t]here is
no level of exposure to lead that is known to be without harmful
effects.'' (Ref. 5).
    Contrary to Combe's assertion, JECFA's statement establishing a
negligible risk level for lead as an unavoidable food impurity does not
provide a ``safe harbor'' for any intentionally added lead in a
cosmetic product. See Submission, page 33. Also, JECFA's negligible
risk level for food does not support Combe's claim that the intended
use of lead acetate in hair dye meets the safety standard of
``reasonable certainty of no harm'' set forth at Sec.  70.3(i) (21 CFR
70.3(i)) because as JEFCA states, currently available data do not
provide any indication of a threshold for the reported adverse effects
from exposure to lead (Ref. 4).
    The objection failed to include any new information or data that
would change our findings about the lack of a safe exposure level of
lead. The objection merely alleges that FDA did not analyze JECFA's
conclusion and does not provide scientific information to support
Combe's argument. A hearing will not be granted on the basis of mere
allegations or general descriptions of positions and contentions (Sec.
12.24(b)(2)). The objector must, at a minimum, raise a genuine and
substantial issue of fact for resolution at a hearing. Therefore, we
are denying the request for a hearing on this objection.
    Objection 5. Combe objects to ``FDA's reliance on EPA's goals for
lead in drinking water.'' Combe states that the EPA goal in setting the
maximum contaminant level for lead in drinking water at zero is based
on the effect of lead in children. See Submission, page 33. Combe
contends that EPA's goal for lead in drinking water ``in no way means,
however, that lead is unsafe in a progressive hair dye for aging men
with graying hair.'' Ibid.
    (Response to Objection 5) FDA did not rely on EPA's goal for lead
in drinking water; we referred to it to further document the adverse
effects resulting from lead exposure. Adverse effects to the public
more generally

resulting from lead exposure are the reason why there is a government-
wide effort to limit lead exposure to the public. Our decision to
repeal the regulation was based on the recognition that there is no
scientific data demonstrating a safe level of exposure to lead and that
the data currently available no longer demonstrate that there is
reasonable certainty of no harm from the use of lead acetate as a color
additive in hair dyes authorized under Sec.  73.2396. Combe fails to
show that there is a genuine and substantial issue of fact for
resolution at a hearing. A hearing will not be granted on the basis of
mere allegations or general descriptions of positions and contentions
(Sec.  12.24(b)(2)). Therefore, we are denying the request for a
hearing on this objection.
    Objection 18. Combe objects to ``FDA taking a zero-tolerance
approach to lead.'' Combe argues that ``FDA appears to draw a legal
distinction between lead that is intentionally added and lead that is
present as impurities. Although such a distinction can be legally drawn
for food, FDA cannot do this for cosmetics.'' See Submission, page 54.
Combe claims that the safety standard for cosmetics is the same,
whether the lead is intentionally added or present as an impurity.
Combe asserts that under section 406 of the FD&C Act (21 U.S.C. 346),
FDA can only set tolerances for poisonous and deleterious substances
for food, and not cosmetics. Combe further asserts that FDA is acting
arbitrarily and capriciously by banning lead acetate in hair dyes, but
not banning it in lipstick. See Submission, pages 55-56.
    (Response to Objection 18) We disagree that the presence of lead as
an impurity in some cosmetic products means that FDA must find that
there is a reasonable certainty of no harm from the use of lead acetate
in hair dyes at levels up to 6,000 ppm (mg/kg). The intended use of
lead acetate is as a color additive and as such we are acting under
sections 721(d) and 601(e) (21 U.S.C. 361(e)) of the FD&C Act. See 28
FR 13374 (December 10, 1963) (providing FDA's interpretation of
sections 601(a) and (e) of the FD&C Act). We have concluded that
intended use of lead acetate does not meet the safety standard of
``reasonable certainty of no harm'' set forth at Sec.  70.3(i) for
color additives. Combe has not demonstrated that the intended use of
lead acetate meets this safety standard. Therefore, we are repealing
the listing of lead acetate under section 721(d) of the FD&C Act, and
its use adulterates a cosmetic under section 601(e) of the FD&C Act.
    Our repeal of the listing of lead acetate as a color additive in
hair dye and our recommendation to limit lead as an unavoidable
impurity in lipstick and other cosmetics are not arbitrary and
capricious actions, as Combe asserts. In our ``Draft Guidance for
Industry: Lead in Cosmetic Lip Products and Externally Applied
Cosmetics: Recommended Maximum Level'' (2016), we recommend lead not be
present as an impurity (not an intentionally added ingredient) in
cosmetics at levels exceeding 10 ppm (10 mg/kg) (Ref. 6).\2\ Lead as an
impurity may occur in any cosmetics due to its background presence in
the environment. Lead as an impurity cannot be completely avoided,
although we have concluded that limiting trace amounts of lead to less
than 10 ppm (10 mg/kg) can be achieved through reasonable and practical
approaches to control raw materials and through other good
manufacturing practices (Ref. 7). The draft guidance does not apply to
hair dyes that contain lead acetate as an ingredient (Ref. 6 at page
3).
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    \2\ The draft guidance, only when finalized, will represent the
current thinking of the FDA on this topic. It does not establish any
rights for any person and is not binding on FDA or the public. You
can use an alternative approach if it satisfies the requirements of
the applicable statutes and regulations.
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    By contrast, lead acetate as a color additive is an intentionally
added ingredient in hair dye and must meet the safety standard for
color additives. We believe that the available data demonstrate that
exposure to lead acetate from the intended use may cause adverse
effects (Refs. 3 and 4). Therefore, the use of lead acetate in hair dye
products that would result in lead levels up to 6,000 ppm (6,000 mg/kg)
in the final products does not meet the safety standard for color
additives.
    Because there is no factual issue Combe identifies in this
objection that can be resolved by available and specifically identified
reliable evidence, we are denying the request for a hearing on this
objection (Sec.  12.24(b)(1)).

B. Category B: The Moore Study

    Combe's numbered objections included in Category B are as follows:

    6. Combe objects to FDA's conclusions that the Moore study
underestimated the exposure to lead.
    7. Combe objects to FDA's criticisms of Moore.
    8. Combe objects to FDA's finding that the lead in the Moore
study could have been absorbed by other parts of the body than the
blood.
    11. Combe objects to FDA's argument that the absorption
percentage from the Moore study is invalid because it tested only a
small patch of skin.

    Objection 6. Combe objects to ``FDA's conclusions that the Moore
study underestimated the exposure of lead.'' Combe asserts that the
Moore study remains the best evidence of the absorption of lead from
lead acetate, that the Moore study protocol was developed with guidance
from FDA, and that FDA acknowledged as much because it used some of the
figures derived from the Moore study in its own modeling. See
Submission, pages 33-34.
    (Response to Objection 6) FDA acknowledges that the Moore study has
some scientific merit. As discussed in our responses to Objections 9,
12, and 13, the fractional absorption (the percentage of the total
amount of lead applied that is absorbed through the skin) from this
study was used to calculate EPA's permeability coefficient (Kp) value
(the rate at which a chemical penetrates the skin), which we used in
our assessment.\3\ Additionally, the results generated by Moore et al.
would be reliable for a situation where the experimental conditions
reflected the intended use conditions. However as explained below, the
intended conditions of use of the lead acetate-containing progressive
hair dyes are different from the experimental conditions in the Moore
study.
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    \3\ Objection 12 provides an additional explanation of
fractional absorption and Kp.
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    New scientific information and computational tools have become
available since the Moore study protocol was developed in the 1970s to
1980. We considered newer scientific information, including peer-
reviewed publications describing nonclinical and clinical studies that
demonstrate that dermally applied lead acetate and other lead compounds
penetrate human and animal skin (Ref. 2). Additionally, newer
computational tools have shown that the surface area of the application
site is an important factor for estimating dermal absorption of lead
and other compounds. This includes the in silico (i.e., via computer
simulation, as opposed to in vitro or in vivo experimental studies)
ConsExpo dermal absorption model that we used to predict the percentage
of dermal lead absorption. Using a surface area that is representative
of the actual application area is also consistent with our recent
guidance for industry, \4\ which provides recommendations for
conducting in vivo absorption trials for topically applied active
ingredients (Ref. 8). The

guidance recommends, in part, that the test article should be applied
to the part of the body and maximal skin surface areas that are
consistent with the final product's intended skin surface area use
(Ref. 8, page 6).
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    \4\ The Wyatt Memorandum (Ref. 2) refers to the draft guidance
(Ref. 6), which has since been finalized.
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    By contrast, the Moore study design--where the lead acetate
formulation was applied to a small surface area on the forehead--did
not reflect either where lead acetate hair dye is intended to be
applied or the surface area of such application. Specifically, in the
Moore study, the lead acetate formulation was tested on only a small
fraction of the skin surface area (i.e., 8 to 10 square centimeters
(cm\2\) on the forehead instead of approximately 580 cm\2\ for the full
scalp). Additionally, the test formulation was applied to an area of
skin without many hair follicles, which may have further underestimated
the amount of lead absorbed. Lead absorption was measured after 12
hours and 24 hours of exposure, and the test formulation was washed off
after the first 12 hours. The study did not investigate the actual
directions of use of this hair dye, which results in accumulation of
lead on the hair and skin. \5\ Therefore, the Moore study
underestimated exposure to lead from the use of lead acetate hair dyes.
Based on these flaws and the additional flaws we identified in the
Moore study, specifically, the formulation used in the study contained
0.12 to 0.18 percent lead (instead of 0.6 percent), the ages of the
eight male test subjects range from 20 to 35 years (instead of older
adults), and the short duration of test article application, which were
discussed in detail in the final rule that appeared in the Federal
Register of October 31, 2018 (83 FR 54665 at 54668 through 54670), we
stated that the Moore study results could no longer be relied on to
make a safety decision for the use of lead acetate as a color additive
in hair dye.
---------------------------------------------------------------------------

    \5\ The manufacturer's use directions state that after the
initial application, users might apply the progressive hair dye
daily until the desired color shade is achieved (usually takes 2-3
weeks), and then once or twice a week to maintain the hair color.
---------------------------------------------------------------------------

    Therefore, considering the reported adverse effects at low levels
of lead exposure (e.g., increased blood pressure, hypertension,
decreased glomerular filtration rate) (83 FR 54665 at 54668), and the
absence of data showing a safe level of lead exposure, we believe that
the safety standard of reasonable certainty of no harm is no longer
met.
    Because Combe has not provided new data that address the identified
flaws in the Moore study, we conclude that Combe's argument on the
Moore study is insufficient to justify a hearing (Sec.  12.24(b)(3)).
Therefore, we are denying the request for a hearing on this objection.
    Objection 7. Combe objects to ``FDA's criticisms of Moore.'' Combe
states that in 1981, FDA concluded that Moore's radioactive tracking
study demonstrated a miniscule amount of lead absorption from lead
acetate hair dyes. See Submission, page 35. Combe further states that
the Moore study result of 0.058 percent is supported by a subsequent
study by Bress and Bidanset (Ref. 2), which estimated absorption of
lead acetate as 0.05 percent. See Submission, at page 37.
    (Response to Objection 7) We acknowledge that, based on the
scientific information available 40 years ago, we considered the 1978
radioactive tracer skin absorption study sponsored by Combe (a
petitioner for CAP 3C0107) and conducted by Moore et al. (published in
1980) to be the primary study supporting the approval of lead acetate
as a color additive in 1980, and that it was applicable for studying
human skin lead absorption at that time. However, as discussed in our
response to Objection 6 and the October 31, 2018, final rule (83 FR
54665 at 54668 through 54670), we have since identified several flaws
in the Moore study design and conduct, such as applying test
formulation with a lower lead concentration, on a smaller surface area
of skin, and for a short period of time, when compared to the intended
conditions of use. For example, as discussed previously, Moore et al.
applied the lead acetate-containing formulation to an 8 to 10 cm\2\
surface area on the forehead without many hair follicles, which is not
consistent with the intended condition of use for the hair dye product
(on the full scalp with many hair follicles and a skin surface area of
approximately 580 cm\2\), thereby underestimating the exposure to lead
from lead acetate-containing hair dye. In addition, the result of 0.058
percent was measured 12 hours after a single application of the hair
dye, which was then washed off. Therefore, the result does not
represent the accumulation of lead from daily use of the hair dye.
Because of these identified flaws and others described in the response
to Objection 6, the fractional absorption calculated from the Moore
study does not accurately represent the actual dermal absorption under
the intended conditions of use, and therefore does not support the safe
use of lead acetate in progressive hair dyes.
    We also reviewed the study published in 1991 by Bress and Bidanset
(Ref. 2). While the results from this study are consistent with those
from the Moore study, Bress and Bidanset also applied the lead compound
to a small skin surface area; thus, their study is of similar limited
utility as the Moore study because it may also underestimate the
exposure to lead from the use of hair dye. The objection failed to
provide new data that address the identified flaws in the Moore study
and the limitation of the Bress and Bidanset study for estimating skin
absorption of lead from the use of lead acetate hair dye, and the
information discussed in this objection is insufficient to justify a
hearing (Sec.  12.24(b)(3)). Therefore, we are denying the request for
a hearing on this objection.
    Objection 8. Combe objects to ``FDA's finding that the lead in the
Moore study could have been absorbed by other parts of the body than
the blood.'' Combe also states that the radioactive tracer skin
absorption study conducted by Moore et al. measured whole body lead
(including lead in the blood, other fluids, tissues, muscle, and bone)
and that Moore et al. calculated that 40 percent of the lead absorbed
by the whole body was absorbed into the blood. See Submission, page 38.
    (Response to Objection 8) In a March 3, 1978, final rule postponing
the closing date for the provisional listing of lead acetate for use as
a component of hair colors (43 FR 8790), we stated that the radioactive
tracer skin absorption study protocol submitted to FDA would measure
whole body counts of lead absorption, and in addition, blood and urine
samples would be analyzed for measurable levels of lead (43 FR 8790 at
8793). However, as further discussed in our response to Objection 12,
the use of fractional absorption to express dermal absorption depends
on the study design (e.g., duration of exposure, how much of the test
material is in contact with a given surface area, the concentration of
the substance in the matrix). Also, as stated in our response to
Objection 6, given its fundamental flaws, the Moore study
underestimated exposure to lead from the use of lead acetate hair dyes.
Therefore, we can no longer rely on this study's exposure estimate to
assure the safe use of lead acetate in hair dye. Combe does not point
to any other studies that have evaluated lead absorption across the
full surface area of the scalp, nor does Combe point to other studies
demonstrating an absorption estimate after correcting the flaw in the
Moore study that could provide evidence that the use of lead acetate in
hair dye is safe.
    A hearing will not be granted on the basis of mere allegations or
general descriptions of positions and contentions (Sec.  12.24(b)(2)).
Therefore, in

the absence of any other evidence, studies, or new scientific
information addressing the flaws identified in the Moore study that
would demonstrate that the use of lead acetate in hair dye is safe, we
are denying the request for a hearing on this objection.
    Objection 11. Combe objects to ``FDA's argument that the absorption
percentage from Moore is invalid because it tested only a small patch
of skin.'' See Submission, page 40. Combe acknowledges that the scalp
has a larger surface area, but states that the use instruction for its
hair dye product is to apply the dye to the hair while avoiding ``areas
you want to keep gray'' and not to apply the product to the scalp. See
Submission, page 41. Thus, Combe claims that its product ``would never
touch the whole scalp.'' Ibid. Combe asserts that Moore's approach of
applying the lead acetate formulations directly to skin on the forehead
was a conservative approach that would substantially overestimate
absorption. Combe further asserts that,

    Moore applied a small amount of hair dye to a small patch of
skin and measured how much of that small amount was absorbed. Thus,
Moore was able to estimate the percentage of the applied dye that
enters the body. This fraction (0.058 percent) was then multiplied
by the actual amount of hair dye that would reach the head, yielding
the amount of absorption that can be expected from the whole
application. By such multiplication, Moore took into account the
application to more than just a small patch of skin. Moore
considered the entire scalp.

    See Submission, pages 41-42.
    Combe also asserts that the way Moore estimated absorption
``remains the standard way that industry and regulators do it today.''
See Submission, page 42. Specifically, Combe states that FDA
``evaluated the dermal absorption of lead as a percentage of the amount
applied to the skin'' in its 2016 draft guidance for lead as an
impurity in cosmetic lip products and externally applied cosmetics, and
that this approach is similar to the approach in the Moore study. Ibid.
    (Response to Objection 11) Our criticism of the Moore study is not
limited to its testing of only a small patch of skin; however, the size
of the skin tested is one relevant factor.
    We note that Combe asserts that lead acetate ``would never touch
the whole scalp.'' See Submission, page 41. Yet, Combe failed to
provide data showing how much of the scalp (by the percent area) is
estimated to be exposed to the hair dye. Without such data, our
assumption that the hair dye would be applied to the surface area of
the scalp that would be expected to be treated with the hair dye
product is consistent with the practices used in an appropriately
designed dermal absorption study. For example, see the European
Commission's Scientific Committee on Consumer Products' (SCCP's)
guidance for testing and evaluating safety of cosmetic ingredients
(Ref. 9). Page 44 of the SCCP guidance document states, ``Hence, when
dermal absorption is expressed as a percentage, the absorbed amount
resulting from in vitro tests has to be expressed as a percentage of
the dose applied in real in use conditions, that can be estimated by
the ratio of the default amount of formulation applied in real
conditions and the respective default value of skin surface area per
product type.''
    In addition, it is likely that some users would apply the product
to the whole scalp. For example, Combe's Grecian[supreg]
Formula16[supreg] liquid and cream products use instructions state that
the user should apply the lead acetate-containing hair dye ``to cover
gray totally, until hair feels slightly damp;'' ``[c]omb hair as
usual;'' ``if desired apply daily until hair reaches desired shade;''
and ``[t]o maintain your natural look, apply once or twice a week
thereafter'' (Ref. 10). The pictures provided in the use instructions
appear to indicate that the dye may be applied on the area of the head
covered by hair (Ibid.). Accordingly, we expect that some users would
follow these instructions and apply the dye and comb the damp hair such
that the dye would widely reach the scalp.
    Nonetheless, Combe asserts that Moore considered ``the entire
scalp,'' by multiplying the percentage of the applied dye that enters
the body (i.e., the fractional absorption) by the ``actual amount of
hair dye that would reach the head.'' See Submission, page 41.
Experimental conditions can impact fractional absorption and are not
independent of skin loading conditions, which can have dramatic effects
on the results (Refs. 11 and 12). The experimental conditions in the
Moore study were drastically different from the intended conditions of
use, thus the fractional absorption measured in this experiment is not
representative of the real fractional absorption under the intended use
conditions. For example, a fractional absorption obtained by applying
0.1 milliliter (mL) of hair dye formulation containing 0.12 percent
lead acetate to an 8 or 10 cm\2\ area of skin on the forehead without
many hair follicles and measured after 12 hours does not accurately
reflect the actual use conditions where 0.18 mL of formulation
containing up to 0.6 percent lead is applied to a 580 cm\2\ area of
scalp area with many hair follicles and is reapplied every 24 hours
until the hair reaches the desired shade (Refs. 1 and 2). Thus, the
relative dermal loading of the hair dye was 0.01 mL/cm\2\ (0.1 mL/10
cm\2\) in the Moore study versus 0.00031 mL/cm\2\ (0.18 mL/580 cm\2\),
which is a 32-fold difference that influences dermal absorption. We do
not consider a study design, in which the test formulation (with lower
lead acetate concentration) was applied to a small surface area on the
forehead (instead of the full scalp) and washed off after an
application period-to be a conservative approach as Combe asserts, nor
do we consider it an accurate measure of lead exposure from the product
use. Thus, we believe that the Moore study underestimated the total
amount of lead that was absorbed.
    With regard to FDA's 2016 draft guidance, as discussed in our
response to Objection 18, this guidance is specific to lead present in
certain cosmetics as an impurity. It is important to note the maximum
permitted use level of 6,000 ppm lead acetate intentionally added to a
hair dye is 600 times greater than the maximum recommended lead level
of 10 ppm as an impurity. For the draft guidance, FDA evaluated the
dermal absorption of lead as a percentage of the amount applied to the
skin in order to assess exposure more generally. The draft guidance
incorporated usage data for three representative cosmetic product
categories (lipstick, eye shadow, and body lotion) and estimated whole
body exposure to lead. The draft guidance considered average daily
usages of lipstick, eye shadow, and body lotion to make generalizations
for lead as an impurity in all categories of cosmetics covered by this
guidance, rather than in each specific category.
    By contrast, for our review of lead acetate, we considered
specifically how much lead would be absorbed from a hair dye to ensure
that this intended use of lead acetate meets the safety standard for
color additives. Because use of lead acetate as a hair dye is
associated with a specific usage scenario limited to only the scalp,
the intended conditions of use, including the surface area of
application, were important in calculating absorption. Because of study
design limitations with the Moore study, we used a published Kp value
(see response to Comment 12 that addresses the Kp value) in a ConsExpo
model to estimate exposure and predict potential percentages of dermal
lead absorption for this specific usage scenario.
    A hearing will not be granted on the basis of mere allegations or
general descriptions of positions and

contentions (Sec.  12.24(b)(2)). Therefore, in the absence of any other
evidence, studies, or new scientific information addressing the flaws
identified in the Moore study that would demonstrate that the use of
lead acetate in hair dye is safe, we are denying the request for a
hearing on this objection.

C. Category C: ConsExpo In Silico [Computer] Modeling

    Combe's numbered objections included in Category C are as follows:

    9. Combe objects to FDA's reliance on a novel and unvalidated
computer model.
    10. Combe objects to FDA's treating an unvalidated computer
model as more reliable than robust human data.

    Objection 9. Combe objects to ``FDA's reliance on a novel and
unvalidated computer model.'' Combe states that FDA failed to explain
whether the model is validated and why it used this particular model.
See Submission, page 39. Combe further claims that FDA never explained
the details of the model, ``how the math works, or why FDA's inputs to
the model are reasonable.'' Ibid.
    (Response to Objection 9) Contrary to Combe's contention, the
ConsExpo dermal absorption model is not novel. The ConsExpo dermal
absorption model is a mathematically based modeling program that
enables general estimation of human exposure to chemicals found in
consumer products via inhalation, skin absorption, and oral intake. The
description of the basis of the ConsExpo dermal absorption model was
first published in 1996 (Ref. 13). The program was developed by the
Netherlands National Institute for Public Health and the Environment
(RIVM) and is available to the public. The program updates are now
released by RIVM in collaboration with other European counterpart
institutes, including the French Agency for Food, Environmental and
Occupational Health and Safety, the German Institute for Risk
Assessment, the Federal Office of Public Health (Switzerland), and
Health Canada. This model has been used by other regulators (e.g.,
Health Canada) and has been cited in various scientific publications,
as listed in Appendix 6 of the Wyatt memorandum (Refs. 2 and 14).
    In the Wyatt memorandum (Ref. 2, Appendices 4 to 6), and in the
October 31, 2018, final rule (83 FR 54665 at 54670), we explained our
decision to use the in silico modeling to predict the percentage of
dermal absorption of lead by the surface area of the full human scalp
and all the parameters and inputs to the model. We chose to use in
silico modeling because, as described in our response to Objection 7,
we had identified several flaws in the Moore study design that resulted
in the underestimation of lead exposure from this intended use.
    Using EPA's Kp value for lead acetate,\6\ we used the ConsExpo
dermal absorption modeling software to estimate absorption based on the
intended conditions of use (including the relevant lead concentration,
surface area, and duration of application period). As stated in
Appendix 4 of the Wyatt memorandum (Ref. 2), we also performed an
internal validation by applying parameters identical to experimental
conditions used in the Moore study into the ConsExpo dermal absorption
model. The model successfully predicts Moore's experimental results
using Moore's study parameters from experimental conditions, which can
be taken as evidence of validation of the model. We believe that no
further validation is needed for the purpose of using the model to fill
gaps in experimental data.
---------------------------------------------------------------------------

    \6\ Kp is a chemical-specific absorption-related constant that
is independent of the surface area, concentration, etc. (see further
description of Kp in our response to Objection 12).
---------------------------------------------------------------------------

    The objection failed to include any new information or data that
would refute our conclusion that the ConsExpo dermal absorption model
was appropriate to use in the manner that we applied it. A hearing will
not be granted on the basis of general descriptions of positions and
contentions (Sec.  12.24(b)(2)). The objector must, at a minimum, raise
a material issue concerning which a meaningful hearing might be held.
Therefore, we are denying the request for a hearing on this objection.
    Objection 10. Combe objects to ``FDA's treating an unvalidated
computer model as more reliable and robust than human experimental
data.'' In this objection, Combe insists that the computer model is not
needed because human data are available and that ``it is unscientific
for a computer model to be used to trump robust human data.'' See
Submission, page 40.
    (Response to Objection 10) FDA agrees that human studies, when
scientifically well-designed and conducted, provide more robust and
reliable data than computer modeling in the safety evaluations of color
additives. As discussed in the Wyatt memorandum and in the October 31,
2018, final rule (83 FR 54665 at 54668 through 54672), we reevaluated
the Moore study and identified significant scientific flaws. Based on
this reevaluation, our current thinking regarding the radioactive
tracer skin absorption study conducted by Moore et al., is that it is
no longer possible to rely on this human data because of these
significant flaws. Consequently, we no longer consider it
scientifically sound to continue the use of the experimental fractional
absorption number derived from this study when the experimental
conditions are not consistent with the intended conditions of use for
the hair dye product. We believe that the flaws in the Moore study may
have resulted in underestimating the exposure to lead from lead
acetate-containing hair dye. We also believe that it is scientifically
valid and appropriate to use the in silico computer model to
extrapolate and predict the absorption to fill the data gaps created by
the absence of data from human experimental studies designed and
conducted to simulate the intended conditions of use for lead acetate-
containing hair dye.
    In this objection, Combe did not provide any information to address
the significant flaws in the Moore study that we identified. This
objection also failed to identify any other human studies that we could
consider in lieu of the in silico computer model. Therefore, we are
denying the request for a hearing on this objection.

D. Category D: Skin Permeability Coefficient

    Combe's numbered objections included in Category D are as follows:

    12. Combe objects to FDA's reliance on a ``permeability
coefficient'' for lead instead of fractional absorption.
    13. Combe objects to FDA's use of a permeability coefficient for
lead acetate that EPA repudiated and replaced with a much lower
estimate.

    Objection 12. Combe objects to ``FDA's reliance on a `permeability
coefficient' for lead instead of fractional absorption.'' Combe argues
that FDA has not demonstrated that the ConsExpo dermal absorption model
has been validated for inorganic substances such as lead, and that FDA
does not explain how the permeability coefficient for lead acetate was
derived and whether it is appropriate for use in the model. See
Submission, page 44. Combe further asserts that we are relying on an
outdated permeability coefficient from EPA. See Submission, pages 43-
44. Because this last argument is also the subject of Objection 13 (see
Submission, page 45), we will respond to this assertion in our response
to Objection 13 below.
    (Response to Objection 12) There are two ways to calculate skin
absorption for exposure assessments: (1) The use of

the Kp and (2) the use of fractional absorption. Kp is a constant
(i.e., the rate at which a chemical penetrates across the stratum
corneum (the outermost layer of the skin, e.g., centimeters per hour
(cm/h) or meters per second (m/s)). The fractional absorption is the
percentage of the total amount of lead applied that is absorbed through
the skin and depends on the study design (e.g., duration of exposure,
how much of the test material is in contact with a given surface area,
the concentration of the substance in the matrix, etc.). Thus, the
extension of an experimental fractional absorption number is only
scientifically valid when the experimental conditions are similar, if
not identical, to the intended condition of use. As discussed
previously, the experimental conditions in the Moore study are
significantly different from the intended conditions of use for the
lead acetate-containing hair dye. For example, as mentioned in our
response to Objection 9, Moore's study was conducted with formulations
containing 6 millimole per liter (mmol/L) or 9 mmol/L lead acetate
(equivalent to 0.12 or 0.18 percent lead respectively), which are three
to five times lower than the maximum use level (0.6 percent lead) in
hair dyes. Second, the test formulation(s) were reportedly applied to a
skin surface area of 8 to 10 cm\2\ on the forehead, an area of the skin
without hair follicles, while lead acetate-containing hair dye is
intended to be applied to the full scalp that has many hair follicles
and a skin surface area of approximately 580 cm\2\. Third, the 12-hour
application period in the Moore study may be too short to assess the
full extent of percutaneous absorption of lead under the intended
conditions of use, which in some cases could remain on the scalp for 24
hours or longer and may accumulate due to repeated applications.
Therefore, application to the small surface area, use of a formulation
with a lower lead concentration, and a shorter exposure period used in
the Moore study all resulted in an underestimation of the fractional
absorption number of lead acetate.
    Therefore, we believe it is appropriate to use the Kp (which allows
the incorporation of parameters, such as the surface area,
concentration, and duration of exposure) in the modeling to determine
dermal absorption. We note that Kp is often the preferred, more
reliable, and commonly utilized parameter to quantify percutaneous
absorption of chemicals from solutions (Refs. 15 and 16).\,\
    We also note that the ConsExpo dermal absorption model can be
applied to an organic or inorganic compound because the underlying
basis for the model is the well-known Fick's law, which describes the
transport of mass, through diffusion, from a region of higher
concentration to a region of lower concentration. The Fick's law-based
equation for the ConsExpo dermal absorption model is described in the
user manual as follows (Ref. 17):
    Aabs = Askin x (1-exp(-P x S x t/V))

Where:
Aabs = Amount of substance absorbed (kg)
Askin = Amount of substance on the skin (kg)
P = Permeability of the skin (m/s) (Equivalent to Kp in the context)
V = Volume of the substance on the skin (m\3\)
S = Exposed skin area (m\2\)
t = Exposure time (s)

As shown in the equation above, the only physicochemical property
related to the chemical itself is the Kp; chemical composition is not a
part of the equation. Thus, this Fick's law-based approach, which is
not dependent on chemical composition, does not need to be specifically
validated according to whether the substance is organic or inorganic
because the permeability (Kp) is a set number. As discussed above in
our response to Objection 9, we used the ConsExpo dermal absorption
model to fill in the existing experimental data gaps (i.e., related to
the small surface area, lower lead concentration, and shorter duration
of exposure) in order to address the differences between the
experimental conditions and the approved intended conditions of use.
    Because the objection failed to provide new data that would change
our conclusion, and the information discussed in the objection is
insufficient to justify a hearing (Sec.  12.24(b)(3)), we are denying
the request for a hearing on this objection.
    Objection 13. Combe objects to ``FDA's use of a permeability
coefficient for lead acetate that EPA repudiated and replaced with a
much lower estimate.'' See Submission, page 45. Combe states that FDA
used a permeability coefficient for lead acetate from, ``an internal
report that EPA has since repudiated.'' Ibid. Combe further states:
``FDA's reliance on this figure is particularly unsupportable given
that EPA in 2004 actually published a permeability coefficient for lead
acetate that is an order of magnitude lower than the internal interim
1992 estimate.'' Ibid.
    (Response to Objection 13) We acknowledge that we used the
permeability coefficient in EPA's 1992 interim report (Ref. 18) (the
larger Kp value of 4 x 10-6 cm/hr), rather than in EPA's
2004 final guidance (Ref. 19) (the smaller Kp value of 0.0005 x
10-3 cm/hr, which is 5 x 10-7 cm/hr), entitled
``Risk Assessment Guidance for Superfund Volume I: Human Health
Evaluation Manual.'' The Kp values in EPA's 1992 and 2004 documents
were both based on the same data set (the Moore study) and they are
both valid. Specifically, the fractional absorption reported by the
Moore study was in a range between 0 to 0.3 percent (Refs. 18, 19, 21,
and 22). While the Kp value in EPA's 1992 document was based on the
upper limit of the reported range (namely a fractional absorption of
0.3 percent), the Kp value in EPA's 2004 document \7\ was based on the
mean of the reported data range (minus the highest value for injured
skin (``dry and scratch'' in the Moore study)) (namely a fractional
absorption of 0.058 percent, instead of 0.3 percent). Using a higher Kp
value--the upper limit of the reported range--is more conservative
because it results in higher predictions of dermal absorption. FDA's
use of this more conservative Kp value is consistent with ensuring
there is a reasonable certainty of no harm from the use of this color
additive.
---------------------------------------------------------------------------

    \7\ We disagree with Combe's characterization of EPA
``repudiating'' the prior Kp value in the EPA 1992 document. We also
note that in its 2004 document, FDA did not independently derive the
Kp value of 0.0005 x 10-3 cm/hr for lead acetate and
instead cited Hostynek et al. (1998).
---------------------------------------------------------------------------

    Had FDA used the smaller Kp value from EPA's 2004 guidance, the
predicted fractional absorption number would have been 3.8 percent
(acknowledged by Combe in Objection 13; see Submission, page 47). The
3.8 percent fractional absorption is more than 10 times higher than
what had been reported in the Moore study as the highest absorption
value. This discrepancy in fractional absorption supports our
conclusion that the Moore study underestimated the amount of lead
absorbed and therefore was flawed. In addition, as stated in the Wyatt
memorandum (Ref. 2, p. 19), FDA did not rely on the predicted levels of
transdermal absorption from modeling to quantify the extent of lead
acetate absorption. Rather, FDA used the predictions from modeling to
show that the Moore study, which was relied on for the listing of lead
acetate as an approved color additive in 1980, may have significantly
underestimated exposure to transdermally absorbed lead from the use of
lead acetate hair dyes (Ref. 2).
    The objection failed to provide new data that would change our
conclusion that there is no longer reasonable certainty that no harm
would result from the listed use of lead acetate in hair dye, and the
information discussed in their objection is insufficient to

justify a hearing (Sec.  12.24(b)(3)). Therefore, we are denying the
request for a hearing on this objection.

E. Category E: Lead Exposure and Blood Lead Levels

    Combe's numbered objections included in Category E are as follows:

    3. Combe objects to FDA's reliance on sources that discuss blood
levels of lead and not exposure levels (see, e.g., NTP monograph).
    14. Combe objects to FDA's conclusion that lower median blood
levels in lead since 1990 mean that any the lead contributed by lead
acetate is less safe now.
    15. Combe objects to FDA's entire analysis because it is missing
two critical links--FDA never relates exposure from lead acetate to
any change in blood lead levels, and thus it never relates it to any
predicted harm.
    16. Combe objects to FDA's whole argument as FDA never links
exposure to lead from lead acetate to a change in steady-state blood
lead levels.
    17. Combe objects to FDA's conclusions about the effect of lead
acetate on blood lead levels.

    Objection 3. Combe objects to ``FDA's reliance on sources that
discuss blood levels of lead and not exposure levels (see, e.g., NTP
monograph).'' Combe asserts that the NTP monograph does not support
that lead is harmful at low levels in adults. See Submission, pages 30-
32. Combe argues that the NTP showed increased risk of potential health
effects (heart and kidney) associated with blood lead levels of 5-10
micrograms per decaliter ([mu]g/dL), while noting that the current mean
blood lead level in U.S. adults is 0.92 [mu]g/dL. See Submission, at
pages 30-31. Combe asserts that there is no evidence that the use of
lead acetate-containing hair dye can raise blood lead levels to >5
[mu]g/dL. See Submission, page 31.
    (Response to Objection 3) With regard to the NTP monograph, the
evaluation found sufficient evidence for an association of adverse
effects on kidney function with blood lead levels of less than 5 [mu]g/
dL in adults (Ref. 3, page 87). A recent literature review by FDA found
that ``the overall body of evidence . . . suggests that some adverse
effects may occur at a blood lead level of 3 [mu]g/dL . . . in adults''
(Ref. 20). In addition, as discussed in our response to Objection 2,
there is a lack of evidence of a safe level of exposure for lead. For
example, JECFA has stated that ``because the dose-response analyses do
not provide any indication of a threshold for the key effects of lead,
the Committee concluded that it was not possible to establish a new
PTWI that would be considered to be health protective'' (Ref. 4, page
212). Furthermore, Combe fails to provide any data that shows the
impact of the use of lead acetate-containing hair dye on blood lead
levels.
    Combe has not provided scientific evidence to support its
contention that the intended use of lead acetate is safe. A hearing
will not be granted on the basis of mere allegations or general
descriptions of positions and contentions (Sec.  12.24(b)(2)).
Therefore, we are denying the request for a hearing on this objection.
    Objection 14. Combe objects to ``FDA's conclusion that lower median
blood levels in lead since 1990 mean that any [of] the lead contributed
by lead acetate is less safe now.'' Combe asserts that because blood
lead levels in the U.S. population are lower now, any amount of lead
contributed by lead acetate ``is safer now because of the overall lower
levels of lead.'' See Submission, page 48.
    (Response to Objection 14) In the October 31, 2018, final rule, we
concluded that any increase in exposure to lead resulting from use of
lead acetate containing hair dye can no longer be considered
insignificant in terms of public health (83 FR 54665 at 54671). Given
that there is no known safe exposure level for lead, we disagree that
any amount of lead contributed by lead acetate-containing hair dye is
safer now. The decrease in blood lead levels since 1990 resulted from
the actions taken by multiple regulatory and public health agencies to
reduce lead exposure in order to minimize potential adverse effects.
For example, we have taken measures to reduce exposure to lead from
our-regulated products to the lowest level that is technically feasible
to protect the public health. Such measures include (but are not
limited to) prohibiting the use of tin-coated lead foil capsules for
wine bottles (21 CFR 189.301) and prohibiting the use of lead-soldering
in food cans (21 CFR 189.240). The decrease in blood lead levels in the
U.S. population, resulting from these measures, does not mean that the
use of lead acetate in hair dye is safe.
    To the contrary, as the science has evolved, more sensitive
endpoints have been identified at lower blood lead levels than known in
the 1970s. A growing body of evidence indicates that adults may
experience adverse health impacts from exposure to lead levels lower
than those previously believed to be harmful. For example, in 2012, the
NTP provided evidence of adverse effects in adult humans (e.g.,
increased blood pressure, hypertension, decreased glomerular filtration
rate) at blood lead levels less than 10 [mu]g/dL, based on
epidemiological evidence (Ref. 3). Also see recent literature review by
FDA that ``the overall body of evidence . . . suggests that some
adverse effects may occur at a blood lead level of 3 [mu]g/dL . . . in
adults'' (Ref. 20). We further note that any additional lead exposure
would contribute to the occurrence of the reported adverse effects of
lead.
    Combe has not provided data to demonstrate that the intended use of
lead acetate-containing hair dyes would not elevate the lead level in
blood and other tissues. A hearing will not be granted on the basis of
mere allegations or general descriptions of positions and contentions
(Sec.  12.24(b)(2)). Therefore, we are denying the request for a
hearing on this objection.
    Objection 15. Combe ``objects to FDA's entire analysis because it
is missing two critical links--FDA never relates exposure from lead
acetate to any change in blood levels, and thus it never relates it to
any predicted harm.'' See Submission, page 49. Combe argues that FDA,
in its conclusion in the final rule that ``we no longer can conclude
that exposure to lead from lead acetate-containing hair dye has no
discernible effect on the steady-state blood lead level,'' did not link
exposure to lead from lead acetate to any change in steady-state blood
lead levels. See Submission, page 49.
    (Response to Objection 15) To satisfy its burden that would justify
its request for a hearing, it is the objector's responsibility to
provide data and scientific information that calls into question our
conclusions. It is not enough to just make an allegation; the objection
needs to contain scientific information to demonstrate the safety of
the color additive under the intended conditions of use. We evaluated
the data and information submitted in the petition (CAP 7C0309) along
with comments submitted in response to the petition and other available
information (including published literature) to arrive at our
conclusion. Based on currently available data, we conclude that there
is no known safe exposure level for lead. This view is consistent with
conclusions by other U.S. agencies responsible for ensuring public
health (e.g., CDC, EPA) and international bodies (e.g., JECFA).
    Combe has not provided data showing that use of lead acetate-
containing hair dyes would not increase the lead level in blood or in
other tissues (including bones). Because a hearing will not be granted
on the basis of mere allegations or general descriptions of positions
and contentions (Sec.  12.24(b)(2)), we are denying the request for a
hearing on this objection.
    Objection 16. Combe ``objects to FDA's whole argument as FDA never

links exposure to lead from lead acetate to a change in steady-state
blood levels.'' See Submission, page 50.
    (Response to Objection 16) Combe's argument in Objection 16 is
essentially the same as its argument in Objection 15. We reiterate that
our determination is based on whether the currently available
scientific evidence shows that there is a reasonable certainty of no
harm from the use of lead acetate-containing hair dye.
    A hearing will not be granted on the basis of mere allegations or
general descriptions of positions and contentions (Sec.  12.24(b)(2)).
Therefore, we are denying the request for a hearing on this objection.
    Objection 17. Combe objects to ``FDA's conclusions about the effect
of lead acetate on blood lead levels.'' See Submission, page 51. Combe
argues that ``the amount of lead that lead acetate contributes to daily
intake (e.g., 0.3 [mu]g) is less than 1 percent of the amount
contributed daily by food, and thus the effect on steady-state blood
lead levels would be expected to be extremely small--on the order of
0.01 [mu]g or less.'' See Submission, page 52.
    (Response to Objection 17) We reiterate that, in lead acetate-
containing hair dyes, up to 6,000 ppm (mg/kg) lead acetate (calculated
as lead) is intentionally added as an ingredient to achieve a coloring
effect; as such, the lead acetate must meet the safety standard of a
reasonable certainty of no harm. There is no lead-containing compound
approved for use as a food additive or color additive in food. Thus,
dietary exposure to lead results from lead that is present as an
impurity in raw materials that manufacturers are unable to avoid
through good manufacturing practices.
    The objection failed to provide new data that changes our
conclusion that the scientific evidence does not support any level of
lead intake that is safe. Therefore, the information discussed in this
objection is insufficient to justify a hearing (Sec.  12.24(b)(3)), and
we are denying the request for a hearing on this objection.

F. Category F: Permitted Lead Acetate Levels

    Combe's numbered objection in Category F is as follows:

    Objection 19. Combe objects to ``FDA's failure to consider
reducing the permitted lead acetate level under 21 CFR 73.2396 from
0.6 percent to 0.153 percent.'' Combe states, ``Since 1998, Combe's
lead acetate hair dyes have contained only 0.153 percent lead,
approximately a quarter of the permitted 0.6 percent under 21 CFR
Section 73.2396.'' Submission, page 56. Combe asserts that ``the
Agency refused to account for this fact in its Final Rule.'' Ibid.

    (Response to Objection 19) We addressed this consideration in the
final rule in our response to Combe's comment (see 83 FR 54665 at
54672). Combe states that it reformulated its lead acetate-containing
products in 1998. See Submission Appendix A, page 1. Reformulating the
hair dye product by reducing the lead content from 0.6 percent to 0.153
percent may reduce the exposure, but it does not establish a safe level
of exposure to lead from lead acetate when used as a color additive in
hair dye. We reiterate that we are not aware of data demonstrating that
any level of lead is safe. We note also JECFA's concluding statement
that it was not possible to establish a new PTWI for lead that would be
considered health protective.
    Moreover, a color additive regulation is not manufacturer or
sponsor-specific and, as such, any manufacturer can use a listed color
additive within the limitations of the regulation. Therefore, it is
appropriate for FDA to conduct its evaluation associated with the
repeal of Sec.  73.2396 based on the maximum permitted use level of 0.6
percent (6,000 ppm; mg/kg) of lead acetate (calculated as lead) in hair
dyes.
    Combe has not provided data that demonstrates with reasonable
certainty that no harm would result from the use of 6,000 ppm (mg/kg)
lead acetate (calculated as lead) as a color additive in cosmetics for
coloring hair on the scalp. A hearing will not be granted on the basis
of mere allegations or general descriptions of positions and
contentions (Sec.  12.24(b)(2)). Therefore, we are denying the request
for a hearing on this objection.

V. Summary and Conclusions

    Section 721 of the FD&C Act requires that a color additive be shown
to be safe prior to marketing. Under Sec.  70.3(i), a color additive is
safe if there is convincing evidence that establishes with reasonable
certainty that no harm will result from the intended use of the color
additive. When new scientific evidence comes to light that calls into
question the safety of an approved color additive, we will evaluate the
new evidence and determine if the color additive continues to be safe
under the condition of use.
    In our October 31, 2018, final rule, we stated that, following a
full evaluation of the data submitted in support of CAP 7C0309 and
other pertinent data and information, we concluded that the data
currently available no longer demonstrate that there is a reasonable
certainty of no harm from the use of lead acetate as a color additive
in hair dyes authorized under Sec.  73.2396. This conclusion was based
on the recognition of the current consensus that there is no safe
exposure level for lead; our reevaluation of the 1980 skin absorption
Moore study that may have resulted in an underestimation of exposure to
lead from its use in hair dye; and the fact that blood lead levels in
the United States have dropped significantly since 1980, so we no
longer could conclude that exposure to lead from lead acetate-
containing hair dyes has no discernible effect on the steady-state
blood lead level. Therefore, we issued a final rule repealing Sec.
73.2396.
    Our responsibility in listing a color additive for safe use in a
regulated product is to evaluate the currently available scientific
data and other pertinent information to determine with reasonable
certainty that the color additive is not harmful under the intended
conditions of use. Considering all the scientific information currently
available, we have not changed our conclusion that the current data no
longer support the safe use of lead acetate as a color additive in
cosmetics intended to color hair on the scalp.
    The burden is on the objector to provide pertinent evidence that
calls into question our conclusion. Despite all its objections, Combe
has not provided any new scientific data or information that establish
with reasonable certainty that there is a level of lead exposure that
could be considered safe and health protective. Combe has also not
provided any new data demonstrating that no harm would result from the
use of up to 6,000 ppm of lead acetate (calculated as lead) as a color
additive intentionally added to cosmetics for coloring hair on the
scalp.
    Therefore, we have determined that the objections do not raise any
genuine and substantial issue of fact that can be resolved by an
evidentiary hearing (Sec.  12.24(b)). Accordingly, we are denying the
requests for a hearing. Furthermore, after evaluating the objections,
we have concluded that the objections do not provide any basis for us
to reconsider our decision to issue the final rule amending Sec.
73.2396 to no longer authorize the use of lead acetate as a color
additive in cosmetics intended for coloring hair on the scalp.
    Under sections 701(e)(2) and 721(d) of the FD&C Act, the filing of
objections operates to stay the effectiveness of our repeal of Sec.
73.2396 until we take final action on the objections. Section 701(e)(3)
of the FD&C Act further stipulates that, as soon as practicable, the
Secretary shall, by order, act upon such objections and make such order

public. We have completed our evaluation of the objections and conclude
that a continuation of the stay is not warranted.
    In the absence of any other objections and requests for a hearing,
we conclude that this document constitutes final action on the
objections received in response to the October 31, 2018, final rule as
prescribed in section 701(e)(2) of the FD&C Act. Therefore, under
sections 701 and 721 of the FD&C Act, notice is given that the
objections and the requests for a hearing filed in response to the
final rule that appeared in the Federal Register of October 31, 2018,
do not form a basis for further stay of the effectiveness of the final
rule. Accordingly, we are ending the stay of the final rule and we are
repealing the listing for lead acetate in Sec.  73.2396 as a color
additive in cosmetics intended for coloring hair on the scalp as of
January 6, 2022.
    In the October 31, 2018, final rule, we stated our intention to
exercise enforcement discretion for a period of 12 months from the
effective date of the final rule regarding marketed hair dye products
that contain the color additive lead acetate to provide an opportunity
for industry to deplete the current stock of hair dye products with
lead acetate and reformulate products prior to enforcing the
requirements of the final rule. We also stated that we had taken into
consideration the fact that bismuth citrate, which is listed in Sec.
73.2110 for use in cosmetic hair dye products at a level up to 2.0
percent weight/volume, was already being used as an alternative for
lead acetate in hair dye products marketed both in the United States
and other countries. Therefore, our intent is to exercise enforcement
discretion for a period of 12 months from the effective date of the
final rule for those hair dye products containing the color additive
lead acetate that comply with the requirements of Sec.  73.2396,
including the specifications, uses and restrictions, and labeling
requirements.

VI. References

    The following references marked with an asterisk (*) are on display
with the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they are also available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
FDA has verified the website addresses, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.

1. Moore, M.R., P.A. Meredith, W.S. Watson, et al., 1980. ``The
Percutaneous Absorption of Lead-203 in Humans from Cosmetic
Preparations Containing Lead Acetate, as Assessed by Whole-Body
Counting and Other Techniques.'' Food and Cosmetics Toxicology,
18:399-405.
*2. Memorandum from M.K. Wyatt, Cosmetics Division, Office of
Cosmetics and Colors, CFSAN, FDA to M. Harry, Division of Petition
Review, Office of Food Additive Safety, CFSAN, FDA, September 18,
2018.
*3. HHS, National Toxicology Program, ``NTP Monograph on Health
Effects of Low-Level Lead,'' June 2012. https://ntp.niehs.nih.gov/ntp/ohat/lead/final/monographhealtheffectslowlevellead_newissn_508.pdf.
4. Evaluation of Certain Food Additives and Contaminants: Seventy-
Third Report of the Joint FAO/WHO Expert Committee on Food
Additives, WHO Tech Report Series No. 960, 2011. http://apps.who.int/iris/bitstream/10665/44515/1/WHO_TRS_960_eng.pdf.
5. WHO, Fact Sheet: Lead Poisoning and Health, August 23, 2019.
https://www.who.int/news-room/fact-sheets/detail/lead-poisoning-and-health.
*6. HHS, FDA, Center for Food Safety and Applied Nutrition. ``Lead
in Cosmetic Lip Products and Externally Applied Cosmetics:
Recommended Maximum Level.'' Draft Guidance, December 2016,
available at https://www.fda.gov/media/99866/download.
*7. Supporting Document for Recommended Maximum Lead Level in
Cosmetic Lip Products and Externally Applied Cosmetics. December
2016, Docket No. FDA-2014-D-2275. http://wcms-internet.fda.gov/cosmetics/cosmetics-guidance-documents/supporting-document-recommended-maximum-lead-level-cosmetic-lip-products-and-externally-applied#VIII.
*8. HHS, FDA, Center for Drug Evaluation and Research. Maximal Usage
Trials for Topical Active Ingredients being Considered for Inclusion
in an Over-The-Counter Monograph: Study Elements and Considerations.
Draft Guidance for Industry. Clinical Pharmacology/OTC, May 2018;
Final Guidance: Maximal Usage Trials for Topically Applied Active
Ingredients Being Considered for Inclusion in an Over-The-Counter
Monograph: Study Elements and Special Considerations, May 2019.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/maximal-usage-trials-topically-applied-active-ingredients-being-considered-inclusion-over-counter.
9. European Commission. ``The SCCP'S Notes of Guidance for the
Testing of Cosmetic Ingredients and Their Safety Evaluation.'' 6th
Revision, 2006. https://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_03j.pdf.
*10. Easy Directions. Grecian[supreg] Formula16[supreg] LIQUID.
Grecian[supreg] Formula16[supreg] CREAM.
11. Frasch, H.F., G.S. Dotson, and S. Wilkinson. ``Analysis of
Finite Dose Dermal Absorption Data: Implications for Dermal Exposure
Assessment.'' Journal of Exposure Science & Environmental
Epidemology, 24: 65-73, 2014. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3868874/.
12. Kissel, J.C. ``The Mismeasure of Dermal Absorption.'' Journal of
Exposure Science & Environmental Epidemiology, 21(3): 302-309, 2010.
https://pubmed.ncbi.nlm.nih.gov/20424648/.
13. Van Veen, M.P. ``A General Model for Exposure and Uptake from
Consumer Products.'' Risk Analysis, 16:331-338, 1996.
14. Health Canada. ``Screening Assessment Acrylates and
Methacrylates Group. October 2018. https://www.canada.ca/en/environment-climate-change/services/evaluating-existing-substances/screening-assessment-acrylates-methacrylates-group.html.
15. Fitzpatrick D., J. Corish, and B. Hayes. ``Modelling Skin
Permeability for Risk Assessment--The Future.'' Chemosphere,
55:1309-1314, 2004.
16. Korinth, G., K.H. Schaller, and H. Drexler. ``Is the
Permeability Coefficient Kp a Reliable Tool in 34 Percutaneous
Absorption Studies?'' Archives of Toxicology, 79, 155-159, 2005.
17. National Institute for Public Health and the Environment,
Ministry of Health, Welfare and Sport. ConsExpo Web, Consumer
Exposure models model documentation, 2017. https://www.rivm.nl/bibliotheek/rapporten/2017-0197.pdf.
*18. EPA. Interim Report. ``Dermal Exposure Assessment: Principles
and Applications.'' Office of Health and Environmental Assessment
EPA/600/8-91/011B, January 1992.
*19. EPA (July 2004). ``Risk Assessment Guidance for Superfund
Volume I: Human Health Evaluation Manual (Part E, Supplemental
Guidance for Dermal Risk Assessment) Final.'' EPA/540/R/99/005,
OSWER 9285.7-02EP, PB99-962212.
20. Dolan, L.C., B.M. Flannery, D. Hoffman-Pennesi, et al. ``A
Review of the Evidence to Support Interim Reference Level for
Dietary Lead Exposure in Adults.'' FDA, Center for Food Safety and
Applied Nutrition, Journal of the International Society of
Regulatory Toxicology and Pharmacology, 111. 2020.
21. Hostynek, J.J., R.S. Hinz, C.R. Lorence, and R.H. Guy. ``Human
Skin Penetration by Metal Compounds.'' Drugs and the Pharmaceutical
Sciences, 91:647-668, 1998.
22. M.S. Roberts and K.A. Walters, eds. ``Dermal Absorption and
Toxicity Assessment,'' Marcel Dekker, Inc., New York.

List of Subjects in 21 CFR Part 73

    Color additives, Cosmetics, Drugs, Foods, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, 21 CFR
part 73 is amended as follows:

PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

0
1. The authority citation for part 73 continues to read as follows:

    Authority:  21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355,
361, 362, 371, 379e.

Sec.  73.2396  [Removed]

0
2. Remove Sec.  73.2396.

    Dated: September 30, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21892 Filed 10-7-21; 8:45 am]
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[Federal Register: May 5, 2010 (Volume 75, Number 86)]
[Notices]
[Page 24708]
[DOCID:fr05my10-97]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0475]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Administrative Detention and Banned
Medical Devices

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Administrative Detention and
Banned Medical Devices'' has been approved by the Office of Management
and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Federal Register of January 19, 2010
(75 FR 2871), the agency announced that the proposed information
collection had been submitted to OMB for review and clearance under 44
U.S.C. 3507. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. OMB has now approved the
information collection and has assigned OMB control number 0910-0114.
The approval expires on February 28, 2013. A copy of the supporting
statement for this information collection is available on the Internet
at http://www.reginfo.gov/public/do/PRAMain.

    Dated: April 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-10580 Filed 5-4-10; 8:45 am]
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[Federal Register: April 15, 2009 (Volume 74, Number 71)]
[Rules and Regulations]
[Page 17405-17406]
[DOCID:fr15ap09-17]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-1170; FRL-8410-1]

Modification of Pesticide Tolerance Revocation for Diazinon

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This final rule resolves an objection filed by the California
Grape and Tree Fruit League in response to a final rule on diazinon
tolerances published on September 10, 2008 (73 FR 52607) by granting
the objection and modifying the revocation of the diazinon tolerance on
grapes to expire on September 10, 2010.

DATES: This final rule is effective April 15, 2009.

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-1170. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Jane Smith, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at
http://www.regulations.gov, you may access this Federal Register
document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://
www.gpoaccess.gov/ecfr.

II. Prior Diazinon Tolerance Rulemaking

    On May 21, 2008 (73 FR 29456) (FRL-8362-1), EPA proposed the
revocation of the tolerance for residues of diazinon, O, O-diethyl O-
[6-methyl-2-(1-methylethyl)-4-pyrimidinyl]phosphorothioate; (CAS Reg.
No. 333-41-5), in or on the food commodity grape at 0.75 parts per
million (ppm) in 40 CFR 180.153(a) because the use on grapes had been
canceled. The proposal neither discussed nor took into account the fact
that an existing stocks provision in the cancellations allowed
continued use of existing diazinon stocks until December 2008. No
comments were received in response to the proposal expressing
objections to the revocation of the diazinon tolerance on grapes. EPA
published a final rulemaking on September 10, 2008 (73 FR 52607) (FRL-
8379-3) revoking the diazinon tolerance on grapes.

III. The California Grape and Tree Fruit League Objection

    On November 10, 2008, the California Grape and Tree Fruit League
filed an objection to the tolerance rulemaking pursuant to 21 U.S.C.
346a(g)(2)(A), objecting to the revocation of the diazinon tolerance on
grapes. The basis of the California Grape and Tree Fruit League
objection is that although the use on grapes has been canceled the
tolerance is ``still necessary to allow for the orderly exhaustion of
existing stocks.'' The California Grape and Tree Fruit League argued
that a tolerance is therefore required for grapes treated with existing
stocks of diazinon to allow the legally treated commodity to clear the
channels of trade and preventing seizure of the treated grapes by the
Food and Drug Administration.

IV. Order on Objection

    Despite the fact that the California Grape and Tree Fruit League
did not comment on this issue with respect to the proposed rule,
because the proposal erroneously failed to take into account the
existing stock provision, EPA in its discretion has considered the
objection and found it to be sound. Accordingly, EPA, by this rule and
order, and pursuant to section 408(g)(2)(C) of the Federal Food, Drug,
and Cosmetic Act (FFDCA), is amending the diazinon tolerance in 40 CFR
180.153(a) to add a tolerance for grape at at 0.75 ppm. The tolerance
will remain in effect until September 10, 2010. The Agency anticipates
this should allow a reasonable period of time for the depletion of
existing diazinon stocks and the clearance of diazinon treated grapes
from the channels of trade.

V. Conclusion

    Therefore, pursuant to section 408(g)(2)(C) of FFDCA, a tolerance
for the residues of diazinon, O, O-diethyl O-[6-methyl-2-(1-
methylethyl)-4-pyrimidinyl]phosphorothioate; (CAS Reg. No. 333-41-5),
in or on the food commodity grapes is added at 0.75 ppm until September
10, 2010.

VI. Statutory and Executive Order Reviews

    EPA included the required statutory discussion in the September 10,
2008 final rule (72 FR 52610).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report to each House of the Congress and
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of the rule in the Federal Register.
This rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: April 2, 2009.
Debra Edwards,
Director, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.153, is amended by alphabetically adding the commodity
to the table in paragraph (a) to read as follows:

Sec.  180.153  Diazinon; tolerances for residues.

    (a) General. * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Grape2...............................................               0.75
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. E9-8117 Filed 4-14-09; 8:45 am]

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