[Federal Register Volume 64, Number 146 (Friday, July 30, 1999)]
[Proposed Rules]
[Pages 41710-41743]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-19191]
[[Page 41709]]
_______________________________________________________________________
Part V
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Parts 801, 878, and 880
Surgeon's and Patient Examination Gloves; Reclassification and Medical
Glove Guidance Manual Availability; Proposed Rule and Notice
Federal Register / Vol. 64, No. 146 / Friday, July 30, 1999 /
Proposed Rules
[[Page 41710]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 801, 878, and 880
[Docket No. 98N-0313]
RIN 0910-AB74
Surgeon's and Patient Examination Gloves; Reclassification
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing
regulations to reclassify all surgeon's and patient examination gloves
as class II medical devices because it believes that general controls
are insufficient to provide a reasonable assurance of safety and
effectiveness. The reclassified gloves, including those made of natural
rubber latex (NRL) or synthetic material, will be regulated in four
categories: Powdered surgeon's gloves, powder-free surgeon's gloves,
powdered patient examination gloves, and powder-free patient
examination gloves. The proposed special controls are in the form of a
proposed guidance document entitled ``Medical Glove Guidance Manual,''
which includes recommended protein and glove powder limits, and new
label caution statements including protein and powder labeling
requirements. FDA is also proposing to require expiration dating. This
proposed rule is intended to reduce the adverse health effects from
allergic and foreign body reactions caused by the natural latex (NL)
protein allergens and glove powder found on surgeon's and patient
examination gloves and to reduce the adverse health effects from
defects in the barrier integrity and quality of surgeon's and patient
examination gloves.
DATES: Written comments by October 28, 1999. Written comments on the
information collection requirements should be submitted by August 30,
1999.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit written comments on the information
collection requirements to the Office of Information and Regulatory
Affairs, Office of Management and Budget (OMB), New Executive Office
Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn.: Wendy
Taylor, Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Donald E. Marlowe, Center for Devices
and Radiological Health (HFZ-100), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4777.
SUPPLEMENTARY INFORMATION:
I. Background
Surgeon's and patient examination gloves are intended to provide an
effective barrier against potentially infectious materials and other
contaminants. However, the use of surgeon's and patient examination
gloves has been associated with a number of adverse health effects in
patients and users, including allergic reactions, foreign body
reactions, and irritation.
NL is a milky fluid that consists of extremely small particles of
rubber obtained from plants, principally from the Heavea brasiliensis
(rubber) tree, dispersed in an aqueous medium. NL contains a variety of
naturally occurring substances, including plant proteins, which are
believed to be the primary allergens associated with NL allergy. NL is
employed in the natural rubber latex manufacturing process. Products
made by the natural rubber latex manufacturing process, such as medical
gloves, are referred to as containing or made of NRL. For a more
complete description of the NRL manufacturing process and further
definition of related terms, see the final rule entitled ``Natural
Rubber-Containing Medical Devices; User Labeling,'' published on
September 30, 1997 (62 FR 51021), and codified in part 801 (21 CFR part
801) at Sec. 801.437.
Glove powder is defined as the total particulate matter on a
finished glove, including donning and dusting powder, as well as
former-release (or mold-release) compounds and manufacturing debris.
The main component of donning and dusting powder is most commonly
cornstarch.
Health care workers, comprised of physicians, dentists,
pharmacists, nurses, technologists, technicians, and phlebotomists, use
millions of NRL gloves during procedures involving millions of
patients; this makes NRL gloves a significant source of exposure to NL
allergens (Ref. 1).
Studies of health care workers, blood donors, and ambulatory
surgical patients have demonstrated an appreciable prevalence of NL
sensitivity (Refs. 2 to 8). FDA has received 330 reports of adverse
events attributed to NL allergy occurring in patients and health care
workers, which suggests that allergic reaction to NRL products in
health care settings manifests itself in a variety of symptoms ranging
from dermatitis to anaphylaxis (Ref. 9). The general population is
directly exposed to NRL from a variety of sources, including consumer
products such as industrial gloves and NRL balloons, as well as medical
devices such as barrier contraceptives and NRL gloves.
FDA has significant concerns about the role of glove powder as a
carrier of airborne allergens, because NL allergens have been shown to
bind to cornstarch. A number of published clinical and experimental
studies support this conclusion (Refs. 10 to 14). In addition to the
role of glove powder as a carrier of airborne allergens, FDA is also
aware that glove powder contributes to a number of other adverse health
effects. As particulate matter, it can cause foreign body reactions,
resulting in inflammation, granulomas and adhesions of peritoneal
tissues after surgery (Refs. 15 to 19). Glove powder may serve as an
absorbent or adsorbent for unbound chemicals that may be irritants or
chemical contact sensitizers. In addition, glove powder from nonsterile
patient examination gloves may also support microbial growth and act as
a carrier for endotoxins (Ref. 20). These multiple concerns of adverse
health effects associated with particulate matter from the surface of
medical gloves constitute compelling reasons for FDA to reduce the
amount of powder on all gloves, as well as to ensure that both powdered
gloves and powder-free alternatives are clearly labeled so users and
consumers may make informed choices. Although data is not currently
available to quantify a maximum allowable level of glove powder,
decreased exposure to glove powder will decrease the prevalence of
adverse health effects. Therefore, FDA is recommending a powder level
it believes is achievable by industry.
In June 1997, the National Institute of Occupational Safety and
Health (NIOSH) issued a safety alert recommending the use of powder-
free, reduced protein content NRL or synthetic gloves as a means to
reduce exposure to NL allergens, specifically via the airborne route of
exposure (Ref. 21). While FDA agrees with the goal of reducing exposure
to airborne allergens, FDA is concerned that efforts to produce powder-
free gloves with satisfactory donning properties may require additional
manufacturing processes that, if not appropriately controlled, have
deleterious effects on physical properties, performance, and shelf-life
of the gloves (Refs. 22 and 23).
[[Page 41711]]
II. Statutory Authority
The Federal Food, Drug, and Cosmetic Act (the act), as amended by
the Medical Device Amendments of 1976 (the 1976 amendments) (Public Law
94-295), the Safe Medical Devices Act of 1990 (SMDA) (Public Law 101-
629), and the Food and Drug Administration Modernization Act of 1997
(FDAMA) (Public Law 105-115), established a comprehensive system for
the regulation of medical devices intended for human use. Section 513
of the act (21 U.S.C. 360c) established three categories (classes) of
devices, depending on the regulatory controls needed to provide a
reasonable assurance of their safety and effectiveness.
The three categories of devices are class I (general controls),
class II (special controls), and class III (premarket approval). The
effect of classifying a device into class I is to require that the
device meet only the general controls that are applicable to all
devices. The effect of classifying a device into class II is to require
the device to meet special controls as well as general controls, which
together provide reasonable assurance of the safety and effectiveness
of the device. Class II devices are devices which cannot be classified
in class I because general controls by themselves are insufficient to
provide reasonable assurance of safety and effectiveness and for which
there is sufficient information to establish special controls to
provide such assurance, including the issuance of performance
standards, postmarket surveillance, patient registries, and guidelines
(see section 513(a)(1)(B) of the act). The effect of classifying a
device into class III is to require each manufacturer of the device to
submit to FDA a premarket approval application (PMA) that includes
information concerning safety and effectiveness of the device.
Under section 513 of the act, devices that were in commercial
distribution before May 28, 1976 (the date of enactment of the
amendments), generally referred to as preamendments devices, are
classified after FDA has: (1) Received a recommendation from a device
classification panel (an FDA advisory committee); (2) published the
panel's recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
A device that is first offered in commercial distribution after May
28, 1976, generally referred to as a postamendments device, and which
FDA determines to be substantially equivalent to a device classified
under this scheme, is classified into the same class as the device to
which it is substantially equivalent. The agency determines whether new
devices are substantially equivalent to previously offered devices by
means of premarket notification procedures in section 510(k) of the act
(21 U.S.C. 360(k)) and part 807 of the regulations (21 CFR part 807). A
device that was not in commercial distribution prior to May 28, 1976,
and that has not been found by FDA to be substantially equivalent to a
legally marketed device, is classified automatically by statute
(section 513(f) of the act) into class III, without any FDA rulemaking
proceeding.
Reclassification of classified preamendments devices is governed by
section 513(e) of the act (21 U.S.C. 360c(e)). This section provides
that FDA may, by rulemaking, reclassify a device (in a proceeding that
parallels the initial classification proceeding) based upon ``new
information.'' The reclassification can be initiated by FDA or by the
petition of an interested person. The term ``new information,'' as used
in section 513(e) of the act, includes information developed as a
result of the reevaluation of the data before the agency when the
device was originally classified, as well as information not presented,
not available, or not developed at that time. (See, e.g., Holland
Rantos v. United States Department of Health, Education, and Welfare,
587 F.2d 1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944
(6th Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).)
Reevaluation of the data previously before the agency is an
appropriate basis for subsequent regulatory action where the
reevaluation is made in light of changes in ``medical science.'' (See
Upjohn v. Finch, supra, 422 F.2d at 951.) However, regardless of
whether data before the agency are past or new data, the ``new
information'' on which any reclassification is based is required to
consist of ``valid scientific evidence,'' as defined in section
513(a)(3) of the act (21 U.S.C. 360c(a)(3)) and 21 CFR 860.7(c)(2). FDA
relies upon ``valid scientific evidence'' in the classification process
to determine the level of regulation for devices. For the purpose of
reclassification, the valid scientific evidence upon which the agency
relies must be publicly available. Publicly available information
excludes trade secret and/or confidential commercial information.
On November 21, 1997, the President signed into law FDAMA. Section
206 of FDAMA added a new section 510(m) (21 U.S.C. 360(m)) to the act.
Section 510(m)(2) of the act provides that FDA may, on its own
initiative or upon petition of an interested person, exempt a class II
device from the requirement of premarket notification in section 510(k)
of the act, if FDA determines that a 510(k) submission is not necessary
to provide reasonable assurance of the safety and effectiveness of the
device. Such an exemption would permit manufacturers to introduce the
generic type of device into commercial distribution without first
submitting a premarket notification to FDA.
Section 701(a) of the act (21 U.S.C. 371(a)) authorizes FDA to
issue substantive binding regulations for the efficient enforcement of
the act. (Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609
(1973); see also Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S.
645, 653 (1973); National Ass'n of Pharmaceutical Manufacturers v. FDA,
637 F.2d 877 (2d Cir. 1981); National Confectioners Ass'n v. Califano,
569 F.2d 690 (D.C. Cir. 1978); National Nutritional Foods Ass'n v.
Weinberger, 512 F.2d 688 (2d Cir.), cert. denied, 423 U.S. 825 (1975).)
Section 502(a) of the act (21 U.S.C. 352(a)) provides that a device
is misbranded ``[I]f its labeling is false or misleading in any
particular.'' Section 201(n) of the act (21 U.S.C. 321 (n)) provides
that, in determining whether labeling of a regulated article (such as a
device) is misleading
* * * there shall be taken into account * * * not only
representations made or suggested by statement, word, design,
device, or any combination thereof, but also the extent to which the
labeling * * * fails to reveal facts material in light of such
representations * * * with respect to consequences which may result
from the use of the article to which the labeling * * * relates
under the conditions of use prescribed in the labeling or
advertising thereof or under such conditions of use as are customary
or usual.
The courts have upheld FDA's authority to prevent false or
misleading labeling by issuing regulations requiring label warnings and
other affirmative disclosures (See, e.g., Cosmetic, Toiletry, and
Fragrance Association v. Schmidt, 409 F. Supp. 57 (D.D.C. 1976), aff'd
without opinion, Civil No. 75-1715 (D.C. Cir. August 19, 1977), even in
the absence of a proven cause-and-effect relationship between product
usage and harm (Council for Responsible Nutrition v. Goyan, Civil No.
80-1124 (D. D. C. August 1, 1980)).
FDA may impose testing requirements in a labeling regulation issued
under its general rulemaking authority. (See, e.g.,
[[Page 41712]]
American Frozen Food Inst. v. Mathews, 413 F. Supp. 548 (D.D.C. 1976),
aff'd per curiam sub nom. American Frozen Food Inst. v. Califano, 555
F.2d 1059 (D.C. Cir. 1977); see also National Nutritional Foods Ass'n
v. Weinberger, supra.) Thus, FDA may require that all manufacturers use
the same conditions to test aging to ensure that the expiration date
reflects the period of time a product can be used safely. Similar
requirements are imposed in Sec. 801.430(f) for absorbency testing for
menstrual tampons, and in Sec. 801.420(c)(4) on hearing aid
manufacturers and distributors who must determine and state technical
data values for hearing aid labeling in accordance with specified test
procedures. The hearing aid regulation has been upheld. (American
Speech and Hearing Ass'n v. Califano, Medical Devices Report (CCH) No.
77-1327 Secs. 15004, 15007 (D.D.C. August 23, 1977) aff'd No. 77-1327
(D.C. Cir. Dec. 19, 1977).) Food regulations issued under section
701(a) of the act also impose many such specific testing requirements
(see e.g., 21 CFR 113.40 (tests for low-acid canned foods); 21 CFR
155.190(b)(2)(i) (test for determining drained weight of canned
tomatos); 21 CFR 161.190 (method for determining color designation of
tuna).
III. Powder and Protein Concerns
Although FDA has been concerned about airborne NL allergens
associated with the use of powdered medical gloves and has undertaken
continued efforts to address these concerns, recent heightened
awareness within the health care community and State and Federal
Government agencies of adverse health effects has prompted this
proposed action.
Over the past 3 years, FDA has received requests to ban the use of
all glove powders. These requests have been based on a number of
clinical and experimental studies reporting that cornstarch on surgical
gloves can reduce tissue resistance to infection, enhance the
development of infection, cause formation of granulomas and adhesions,
act as a carrier of NL protein from NRL products, and serve as a
potential source of occupational asthma. Although a ban of all powdered
medical gloves has been requested by petitioners and would reduce the
problem of airborne powder, it would not completely address the problem
of NL allergy and would potentially leave a significant and important
need for high quality barrier products unmet.
One of the concerns regarding glove powder, in general, is its
capability, as particulate material, to cause foreign body reaction,
resulting in inflammation, granulomas and adhesions of peritoneal
tissues after surgery (Refs. 15 to 19). Although cornstarch was
considered to be absorbable by United States Pharmacopeia (USP),
changes in the sterilization processes have reduced absorbability
significantly (Ref. 15). Cornstarch represents a growth source for
bacteria, and it is also a carrier of endotoxin, which can play a role
in enhancing both delayed and immediate hypersensitivity (Ref. 20).
Clinical experience suggests that powder on NRL gloves, in addition to
its role in Type I allergy, may also be a contributing factor in the
development of irritant dermatitis and Type IV allergy. Irritant skin
reactions have been observed in association with frequent exposure to
glove powder. Compromised skin barrier properties resulting from such
reactions may permit penetration of allergens and other substances into
the skin, thereby increasing chances for the development of both Type I
and Type IV allergy (Ref. 24).
In addition, a significant concern, specific to NL gloves, exists
regarding the role of glove powder as a carrier of airborne NL
allergens. A number of respiratory problems and episodes of bronchial
spasms in hospital employees and patients, reported since the mid
1980's, were ascribed to inhalation of airborne NL allergens in
settings with heavy use of powdered gloves (Refs. 25 to 30). The
implication of glove powder in the previous clinical reports was based
on medical histories of individuals presenting with symptoms, on
positive skin tests, positive tests for the presence of antibodies to
NL allergens in blood and, in some cases, on positive inhalation
challenge tests. A number of published clinical and experimental
studies support this conclusion.
Binding of NL proteins to cornstarch was demonstrated in recent
laboratory studies, which support a causal relationship between
asthmatic reactions in individuals with NL allergy and the exposure to
airborne particles from NL products (Refs. 10 and 11). The level of
exposure and the severity of the reactions depend on both the amount of
powder and the amount of NL protein allergens on the finished products.
Measurements of airborne particle levels in environments where NL
gloves were used frequently demonstrated that the level of airborne
allergen is directly related to the frequency of powdered NL glove
usage in particular areas and to the level of allergen and/or powder on
the gloves used (Refs. 12 and 14).
Direct evidence that NL protein allergens, bound to the glove
powder particles, provoke respiratory allergic reactions and asthma-
like attacks has been documented by the bronchial provocation tests
with powders on NL gloves. The bronchial provocation tests were
performed by having allergic individuals inhale the extracts from
powder-free surgeon's gloves, from powdered surgeon's gloves, and from
cornstarch powder not exposed to NL. The studies indicated that
cornstarch powder not exposed to NL did not cause any reaction in
sensitized subjects, while nebulized powdered NL surgeon's glove
extract, and to some extent, nebulized powder-free glove extract
induced bronchoconstriction in tested subjects (Ref. 31).
However, the scientific data to define the quantitative
relationship between respiratory allergic reactions and powder level on
NL gloves are not available at this time. Such data and the specific
dose-response relationship would be difficult to establish, because
allergenicity of the airborne glove powder depends on the amount of
powder and also on the amount of powder-bound allergenic proteins.
Standardized methods for measuring the amount of powder-bound proteins
or allergens and the amount of inhaled powder are not available.
NL protein has been widely reported as a cause of Type I
sensitivity in individuals who have been exposed to NL devices (Refs. 2
to 8). Repeated exposure to NL protein is considered to increase the
probability that an individual will become sensitized. Total water-
extractable protein on the finished NL product is considered an
indirect measure of the potential allergenicity. Because several NL
proteins have already been identified as allergenic and others may be
identified in the future, exclusion of any proteins from the evaluation
may result in an inaccurate determination of potential allergenicity.
The total water-extractable protein level measured using the standard
American Society for Testing and Materials (ASTM) D 5712 method was
found to correlate well with currently used allergen measurement
methods. Most importantly, a total water-extractable protein level
correlates also with the skin prick test, which is a direct measure of
allergic response in sensitized individuals (Ref. 32). Since May 1991,
FDA has advised manufacturers of NL devices to reduce the water-
extractable protein on their NL devices. This reduction is now
addressed in the Quality System (QS) Regulation at 21 CFR 820.3(p) and
820.70(h).
[[Page 41713]]
Initially, a labeling claim for a protein level was not accepted in
a 510(k) submission because a standard test method for measuring water-
extractable protein in NL did not exist. In 1995, with the help of
industry and FDA, ASTM published the ``ASTM Standard Test Method for
Analysis of Protein in Natural Rubber and its Products, D 5712-95.''
FDA subsequently issued a document entitled ``Interim Guidance On
Protein Content Labeling Claim For Latex Medical Gloves,'' which is
based on this test method. Manufacturers were allowed to use this
guidance to submit a 510(k) submission for NL gloves identifying the
level of water-extractable protein for the device. FDA is now proposing
that a recommended limit on water-extractable protein per glove and the
actual protein level appear on the label.
The amount of powder required for satisfactory donning of gloves
has not been quantified, and the level of glove powder used varies
greatly. Limited laboratory data from measurements of a number of
surgeon's and patient examination gloves demonstrated that powder
levels ranged from 70 to 375 milligrams (mg) per glove for surgeon's
gloves and from 50 to 426 mg per glove for patient examination gloves
(Ref. 31). Because of the multiple concerns regarding adverse health
effects associated with particulate matter from the surface of
surgeon's and patient examination gloves, FDA is now proposing that a
recommended limit on glove powder and the actual level of glove powder
appear on the label. FDA recognizes there is a correlation between
powder level and ease of glove donning and that powder level is
correlated with adverse health effects. For this reason, FDA is
encouraging industry to find the balance between donning requirements
and reducing the risks of adverse health effects.
Lowering the powder level and the amount of protein on surgeon's
and patient examination gloves will reduce exposure to NL allergens and
benefit both allergic individuals and those at risk to develop allergy.
In addition, the reduction of glove powder levels will help reduce
exposure to particulate materials responsible for foreign body
reactions. However, the reduction of powder and protein levels must be
accomplished by methods that do not compromise the availability of or
barrier properties of surgeon's and patient examination gloves.
IV. Barrier and Other Quality Issues
In the Federal Register of October 21, 1980 (45 FR 69723), FDA
issued a final rule classifying the patient examination glove into
class I and exempting manufacturers of the device from compliance with
premarket notification procedures under section 510(k) of the act and
certain requirements of the current good manufacturing practice (CGMP)
regulation. FDA granted the exemptions in the 1980 regulation because,
at that time, no adverse experiences had been related to patient
examination gloves. Furthermore, the role of the gloves as a protective
barrier against human immunodeficiency virus (HIV) transmission was not
recognized and the concomitant risks associated with glove failure were
not well understood.
In the Federal Register of January 19, 1982 (47 FR 2810 at 2852),
FDA proposed that the surgeon's glove be classified into class II
because of concerns about tissue compatibility and the risk of
infection if the devices were not properly sterilized. Comments offered
in response to the proposed classification stated that those problems
could be addressed through general controls, including labeling and
CGMP adherence, and recommended that the device be classified into
class I because of the history of its safe and effective use. In the
Federal Register of June 24, 1988 (53 FR 23856), FDA issued a final
rule classifying the surgeon's glove into class I without exemptions.
Manufacturers and importers of surgeon's gloves have been required to
comply with the premarket notification and CGMP regulations since the
initial classification of the device.
Over the years, many issues regarding surgeon's and patient
examination gloves have been brought to the attention of FDA. The
acquired immune deficiency syndrome (AIDS) epidemic resulted in an
elevated reliance on medical gloves as a barrier against blood-borne
viral transmission. The increased demand for gloves soon outstripped
the domestic supply. Foreign glove manufacturers began to meet the
demand for additional gloves. Many manufacturers with little or no
medical glove manufacturing experience began operations, resulting in
large quantities of gloves of uncertain quality entering the U.S.
market.
Following the advent of AIDS as a major public health concern and
recommendations from the Centers for Disease Control and Prevention
(CDC) that health care workers use appropriate barrier precautions to
prevent exposure to the HIV virus, FDA recognized the need for greater
assurance that cross-contamination between patients and health care
workers be prevented. Accordingly, in the Federal Register of January
13, 1989 (54 FR 1602), FDA revoked the exemption for patient
examination gloves from certain CGMP requirements in order to assure
that manufacturers provide an acceptable manufacturing quality level.
FDA similarly revoked the exemption from premarket notification
requirements for patient examination gloves. On December 12, 1990 (55
FR 51254), FDA published regulations describing certain circumstances
under which surgeon's and patient examination gloves would be
considered adulterated, and establishing the sampling plans and test
methods the agency would use to determine whether gloves were
adulterated (Sec. 800.20 (21 CFR 800.20)). Subsequently, FDA initiated
inspections of glove manufacturers to assure conformance with the
acceptable quality levels (AQL) identified in that regulation.
FDA has sought to address many concerns regarding the quality and
barrier integrity of medical gloves. Certain processes or conditions
can often contribute to degradation of the barrier. NL degrades if it
is not correctly formulated and processed. Proper formulation includes
the use of stabilizers, antiozonants, and antioxidants to reduce
degradation. Improper curing can also cause thin spots on the glove
surface, which may lead to early barrier failure.
Gloves composed of synthetic polymer, such as nitrile, are produced
by essentially the same processes as NL. The same accelerators,
antioxidants, and stabilizers are used to reduce degradation. Thus,
improper formulation and processing may also lead to rapid degradation
of synthetic gloves.
Storage conditions can also cause degradation of the polymers,
whether natural or synthetic. These storage conditions include the
temperature at which the material is held, the humidity of their
environment, and any radiation (for example, sunlight or fluorescent
lights) to which the material may be exposed.
Additionally, chlorination is widely used to reduce the tackiness
of NL gloves and thus eliminate the need for donning powder.
Chlorination works by degrading the surface of the gloves. Therefore,
chlorination must be carefully controlled in order to prevent
destruction of the glove barrier. Improperly chlorinated gloves rapidly
degrade, and breaks in the latex film may occur in a matter of months.
Another concern has been the presence of minute defects known as
pinholes, which directly affect the barrier integrity of the gloves.
FDA studies of micro-photographs of
[[Page 41714]]
defective NL devices have shown that dust, dirt, rust, paint chips,
charred starch, insect parts, and other debris may cause pinholes.
Therefore, appropriate environmental and processing controls, as
required by the QS regulation, are needed. Manufacturers also need to
control other causes of pinholes such as former vibration, air bubbles
in the dipping tanks, dirty formers, incorrect formulation, and
excessive curing temperatures.
If gloves have pinholes, breaks or tears, viruses can potentially
penetrate the glove wall, eliminating or reducing the gloves'
effectiveness as a barrier. On April 6 and 7, 1989, the University of
Maryland, in conjunction with FDA, held a conference entitled ``Latex
as a Barrier Material,'' which reiterated the value of NL as a barrier
film and generated continued support towards more research in this area
by industry and FDA.
Although manufacturers have data to show that their gloves meet
their company AQL for defects when the gloves are shipped, for some
manufacturers, the same gloves which passed the manufacturer's tests
are sometimes rejected at the port of entry in the United States
because the gloves fail the FDA water leak test at that point. This
test result disparity, whether due to degradation or for other reasons,
is a primary reason why, upon importation, the gloves of some
manufacturers have been detained without physical examination.
Manufacturers should assure, by means of stability testing, that their
surgeon's and patient examination gloves will continue to meet the
manufacturers' specifications over the expected life of the gloves.
FDA is aware that microbial growth on gloves also can be a problem.
The QS regulation requires manufacturers to control processing,
shipping and storage environment, and contamination when these can
adversely affect the product. Therefore, processing controls should
include: Using only cornstarch with an acceptable bioburden, properly
storing the cornstarch until it is used, applying cornstarch by
established procedures, cooling the cornstarch slurry and/or using an
antimicrobial in the cornstarch slurry tanks, checking finished gloves
on a sampling basis to assure that excessive cornstarch is not applied,
keeping the finished gloves clean, establishing and meeting a dryness
specification for finished gloves, and protecting finished gloves from
adverse environmental conditions.
Although synthetic materials have improved in recent years, NL
gloves may be superior to some synthetic gloves in regard to barrier
properties (Ref. 34). Both NL and synthetic surgeon's and patient
examination gloves provide protection against microorganisms; however,
it has been demonstrated that compared to vinyl, NL has more effective
and durable barrier qualities (Refs. 35 and 36).
There are other safety and performance issues related to gloves and
other barrier devices that are currently being considered by industry
and FDA. These issues include puncture resistance, tear resistance,
reliability, and biocidal claims.
V. The Proposed Rule
Based upon new information that was not presented, not available,
or not developed when FDA originally classified surgeon's and patient
examination gloves, FDA has reevaluated its classification in light of
changes in the medical science discussed in sections III and IV of this
document. The new, publicly available, valid scientific evidence
demonstrates that these gloves should not remain as class I devices
because of: (1) Barrier integrity concerns; (2) degradation of quality
during storage; (3) contamination concerns; and (4) concerns about
exposure to NL allergens and the role of glove powder as a carrier of
airborne NL allergens, and the inability of general controls to address
these concerns. The agency believes that general controls are no longer
sufficient to provide reasonable assurance of the gloves' safety and
effectiveness and, therefore, FDA is proposing that these gloves be
reclassified into class II.
Surgeon's and patient examination gloves are intended for use as an
effective barrier against potentially infectious materials and other
contaminants. Risk to the user or patient may result from lack of
barrier integrity from degradation, pinholes, breaks, tears, or loss of
quality during storage, potentially causing penetration of the glove
wall by viruses or other infectious materials. When glove powder comes
into contact with compromised human tissue, risk to the user or patient
may result from foreign body reactions caused by NL allergens bound to
the glove powder. Allergic reactions may also be caused by inhalation
of NL allergens bound to the glove powder. Reducing the degree of risk
to acceptable levels depends on effective maintenance of the barrier
properties of the gloves and on reducing exposure to NL allergens,
particularly exposure to airborne NL allergens. The highest risk
products are those with large amounts of glove powder and NL protein
and those products with poor barrier properties.
In order to enable users to distinguish between powdered and
powder-free gloves and to choose the glove type appropriate for their
needs, FDA proposes to reclassify surgeon's gloves into two separate
classifications, based on powder level: Powdered surgeon's gloves, and
powder-free surgeon's gloves. FDA similarly proposes to reclassify
patient examination gloves into two categories: Powdered patient
examination gloves, and powder-free patient examination gloves.
FDA is proposing that these gloves be subject to two special
controls: A guidance document entitled, ``Medical Glove Guidance
Manual,'' and new user labeling requirements. FDA believes that the
proposed guidance document and user labeling requirements are necessary
to provide reasonable assurance of the safe and effective use of the
devices. The guidance is currently being issued in draft as a Level 1
guidance consistent with the good guidance practices (GGP's) FDA
adopted for the development, issuance, and use of guidance documents
(62 FR 8961, February 27, 1997). Elsewhere in this issue of the Federal
Register, FDA is announcing the availability of the guidance in draft
form, to provide an opportunity for comment.
The proposed guidance document recommends that manufacturers of
powdered surgeon's and patient examination gloves limit the amount of
powder to no more than 120 mg of powder per glove, regardless of glove
size. In order to limit total exposure to the user, a ``per glove''
measurement (mg per glove) is used instead of the ``per unit'' dose (mg
per gram (g) of glove material). Under the proposed labeling
requirements, manufacturers of all powdered gloves would be required to
include the actual level of glove powder on the label. FDA believes
that the recommended limit should be sufficient for proper donning of
gloves, but would reduce exposure to airborne glove powder particles.
In addition to the role of glove powder as a carrier of airborne
allergens, FDA is also aware that glove powder contributes to a number
of other adverse health effects. As particulate matter, it can cause
foreign body reactions, resulting in inflammation, granulomas and
adhesions of peritoneal tissues after surgery (Refs. 15 to 19). Glove
powder may serve as an absorbent or adsorbent for unbound chemicals
that may be irritants or chemical contact sensitizers.
The proposed guidance document further recommends that
manufacturers of powder-free surgeon's and patient
[[Page 41715]]
examination gloves limit the amount of total trace (residual) powder to
no more than 2-mg particulate weight (based on the ASTM test standard D
6124-97) per glove, regardless of glove size. Previously, this limit
was recommended to manufacturers who wanted to market gloves with a
powder-free labeling claim. A number of premarket notification
submissions based on this claim already have been cleared for market.
The proposed guidance document also recommends that manufacturers
of NL surgeon's and patient examination gloves limit the amount of
water-extractable protein on the gloves to no more than 1,200
micrograms (g) of protein per glove, regardless of glove size.
In order to limit total exposure to the user, a ``per glove
measurement'' (mg per glove) is used instead of a ``per unit'' dose (mg
per g of glove material). Under the proposed labeling requirements,
labeling on all NL gloves would be required to include the level of
water-extractable protein measured, as recommended in the guidance, by
the currently recognized ASTM D 5712 modified Lowry method. The lowest
acceptable amount of water-extractable protein that may be stated in
the labeling will be limited by the sensitivity of the current ASTM D
5712 test method to 50 g of protein per g of natural rubber
product (which translates to 300 g per glove for a 6 g glove,
i.e., 6 x 50 = 300). FDA believes that without a more sensitive
standard method, lower claims would be misleading.
The proposed labeling requirements are a special control intended
to provide guidance to users of surgeon's and patient examination
gloves. They would require manufacturers to provide new caution
statements, which would include both the FDA recommended limit for
glove powder and protein levels, as well as the actual glove powder and
protein levels present in the manufacturer's gloves. The labeling
special control provides essential decisionmaking information for
health professionals, patients, and lay users. The information required
under the proposed regulations would assist health care professionals,
patients and lay users to select a lower risk device by providing
information about protein and glove powder levels.
The proposed caution statements would be required to appear on all
device labels and other labeling, including the principal display panel
of the device packaging, the outside package, container or wrapper, and
the immediate device package, container or wrapper. The proposed
caution statements for powdered and powder-free NL gloves (surgeon's
and patient examination) would supersede the caution statements in
Sec. 801.437(d) for devices containing NRL currently required in the
regulation published in the Federal Register of September 30, 1997
(effective September 30, 1998).
Labeling for powdered surgeon's and patient examination gloves
containing NL that contacts humans would be required to bear the
following statement:
``Caution: This product contains natural rubber latex which may
cause allergic reactions. FDA recommends that this product contain
no more than 120 mg powder and 1,200 g extractable protein
per glove. This product contains no more than [insert level] mg
powder and no more than [insert level] g extractable
protein per glove.''
Labeling for powder-free surgeon's and patient examination gloves
containing NL that contacts humans would be required to bear the
following statement:
``Caution: This product contains natural rubber latex which may
cause allergic reactions. FDA recommends that this product contain
no more than 1,200 g extractable protein per glove. This
product contains no more than [insert level] g extractable
protein per glove.''
FDA is also proposing new labeling requirements for powdered gloves
made of synthetic material. FDA proposes that labeling for those gloves
bear the following statement:
``Caution: Glove powder is associated with adverse reactions.
FDA recommends that this product contain no more than 120 mg powder
per glove. This product contains no more than [insert level] mg
powder per glove.''
FDA is proposing no new labeling for powder-free surgeon's gloves and
patient examination gloves made of synthetic materials.
FDA is also proposing to require expiration dating on the labeling
of all powdered surgeon's and patient examination gloves and powder-
free surgeon's and patient examination gloves. Previously, expiration
dating has not been required for surgeon's or patient examination
gloves, although it is customary for surgeon's gloves to bear an
expiration date for sterility. A few glove manufacturers have
voluntarily used expiration dates based on real-time data to support
the integrity of the gloves throughout the shelf-life period.
In view of the quality concerns discussed in section IV of this
document, especially those relating to degradation of barrier integrity
over time, FDA believes that expiration dating is necessary to allow
users to correctly store and use stock of gloves, and to allow users to
avoid gloves that may have degraded. Users must be aware of the
potential for degradation of gloves in order to safely use such
products to provide a barrier from infectious agents. Accordingly, FDA
believes that shelf life is a fact material to the consequences of use
of surgeon's and patient examination gloves. Therefore, FDA is now
proposing that all surgeon's and patient examination gloves be required
to bear an expiration date on their primary and retail packaging and
shipping carton. The expiration date should consist of the month and
year for which data exists to support the shelf-life of the gloves. The
time period upon which the expiration date is based starts with the
date of manufacture.
This expiration date must be based on testing conducted according
to a validated stability study protocol to determine the shelf-life of
the gloves. The stability study protocol should employ tests commonly
used by industry to demonstrate the physical and mechanical integrity
of the gloves over their claimed shelf-life.
Manufacturers will not be required to provide new section 510(k) of
the act submissions to demonstrate the shelf-life of gloves. However,
for each distinct glove design, the records of study protocols and test
data must be retained for a period equivalent to the design and
expected life of the gloves, and must be made available for inspection
by FDA personnel.
Expiration dates for sterile surgeon's or patient examination
gloves should either be based on the shelf-life determined by stability
studies as outlined in the proposed rule, or on the sterility shelf-
life, whichever is shorter. Only one expiration date should appear on
each product.
FDA does not intend to require a new submission under section
510(k) of the act based upon labeling changes or reductions in glove
powder or NL protein made to comply with any final regulation based
upon this proposed regulation, provided that no other changes requiring
a new 510(k) submission under Sec. 807.81 are made to the device.
Section 510(m) of the act allows FDA to exempt a class II device
from the requirement of premarket notification in section 510(k) of the
act. FDA does not intend to exempt powdered or powder-free surgeon's or
patient examination gloves from premarket notification because of FDA's
concerns regarding the effective maintenance of barrier properties and
adverse health effects associated with NL allergens, glove powder and
residual chemical sensitizers and irritants.
This proposed rule would not impose requirements on glove users or
user facilities. Therefore, it would not affect
[[Page 41716]]
the authority of the Secretary of Labor, under the Occupational Safety
and Health Act (OSH act), to enforce regulations, standards, or other
directives issued under the OSH act.
VI. Specific Request for Comments
FDA recognizes that this regulation affects surgeon's and patient
examination gloves in different ways, depending on glove powder level.
FDA also recognizes that manufacturing processes for powdered and
powder-free gloves vary. FDA welcomes comments on all aspects of the
proposed regulation, but particularly invites comments on the following
issues:
1. FDA requests comments on the timeframe for implementation of the
proposed rule considering the need for changes in production,
technology, and labeling, as well as the immediate need to address
adverse health concerns associated with medical gloves. Although FDA
prefers a 1-year effective date, FDA is proposing a 2-year effective
date based on indications from industry that the necessary changes
could not be made in 1 year and that a shortage of medical gloves could
result.
2. In the proposed guidance document, FDA recommends a limit of no
more than 120 mg powder per powdered glove, regardless of size, as the
maximum level in order to reduce exposure to particulates and airborne
allergens. FDA requests comments on the recommended limit with regard
to the minimum level of powder needed for adequate donning of gloves.
3. FDA requests comments on the feasibility and desirability of
additional labeling requiring manufacturers to state the primary
ingredients in glove powder in the product labeling.
4. In the proposed guidance document, FDA is recommending no more
than 2 mg powder per glove, regardless of size, as the recommended
powder level for those surgeon's and patient examination gloves labeled
``powder-free.'' FDA requests comments on the proposed limit. FDA is
also seeking comments on the possible impact of this powder limit on
barrier properties and shelf-life of NL gloves.
5. FDA is also considering a future requirement that all surgeon's
and patient examination gloves marketed in the United States be powder-
free. FDA requests comments as to whether a continued need for powdered
gloves exists, and, if so, the reason for this need.
6. FDA considered restrictions on the sale (advertising),
distribution, and use of powdered surgeon's and patient examination
gloves. FDA is seeking comments on the feasibility of such
restrictions.
7. In the proposed guidance document, FDA is recommending an upper
limit of no more than 1,200 g protein per NL glove, regardless
of size, as the maximum level for NL surgeon's and patient examination
gloves. FDA is seeking comments on the proposed recommended limit.
8. FDA's objectives in this proposed rulemaking are to reduce
adverse health effects from allergic reactions and foreign body
reactions by controlling the levels of water-extractable protein and
glove powder on NL gloves. FDA requests comments as to whether there
are feasible alternative approaches to achieve these objectives. If
other alternatives or data submitted present feasible methods to
protect the public health or suggest that different powder or protein
levels are adequate to protect the public health, FDA may incorporate
such data or approaches in a final rule.
9. FDA also invites comments on the issue of whether the
recommended limits on powder and protein proposed in this rule should
be recommended limits or required limits.
10. FDA considered allowing manufacturers to establish an initial
tentative shelf-life up to a certain duration based on accelerated
aging data, provided that manufacturers initiate concurrent real-time
shelf-life studies to confirm and extend the tentative shelf-life. FDA
has been unable, however, to determine whether any validated stability
study protocols exist employing accelerated aging methodologies. The
agency invites comments or information on the availability of
accelerated aging stability study protocols which are predictive of
glove shelf-life. If convincing information concerning such protocols
is available, FDA may incorporate such an approach in a final rule.
11. FDA considered requiring the use of a special air handling
system at the point of use for those facilities using powdered
surgeon's and patient examination gloves with powder levels over 120 mg
per glove, regardless of glove size. FDA is seeking comments on the
appropriateness of this restriction.
12. FDA seeks comments as to whether a provision permitting
affected persons to request exemptions or variances from the labeling
requirements or restrictions on distribution and use proposed in this
rule should be added.
VII. General Request for Comments
Interested persons may submit written comments regarding this
proposed rule by October 28, 1999, to the Dockets Management Branch
(address above). Comments regarding the information collection
provisions should be submitted by August 30, 1999, to the Office of
Information and Regulatory Affairs, Office of Management and Budget
(address above). Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the office above between 9
a.m. and 4 p.m., Monday through Friday.
VIII. Access to Special Control
The availability of the special control entitled ``Medical Glove
Guidance Manual'' is being announced elsewhere in this issue of the
Federal Register. A copy of the ``Medical Glove Guidance Manual'' may
be seen by interested persons in the Dockets Management Branch (address
above) between 9 a.m. and 4 p.m., Monday through Friday.
Persons interested in obtaining a copy of the guidance may also do
so using the World Wide Web (WWW). FDA's Center for Devices and
Radiological Health (CDRH), maintains an entry on the WWW for easy
access to information including text, graphics, and files that may be
downloaded to a PC with access to the Web. The CDRH home page is
updated on a regular basis and includes the draft ``Medical Glove
Guidance Manual;'' device safety alerts; Federal Register reprints;
information on premarket submissions (including lists of approved
applications and manufacturers' addresses); small manufacturers'
assistance; and information on video conferencing and electronic
submissions, mammography matters, and other device-oriented
information. The CDRH home page may be accessed at ``http://
www.fda.gov/cdrh''.
Submit written requests for single copies of the draft guidance to
the Division of Small Manufacturers Assistance, Center for Devices and
Radiological Health (HFZ-220), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive
labels to assist that office in processing your request, or fax your
request to 301-443-8818.
To receive the directions via fax machine on receiving the proposed
guidance document, call CDRH Facts-on-Demand system at 800-399-0381, or
301-827-0111 from a touch-tone telephone. At the first voice prompt,
press 1 to access the Division of Small Manufacturers Assistance (DSMA)
Fax, at the second voice prompt, press 2, and then enter the document
number 852
[[Page 41717]]
followed by the pound sign (#). Then follow the remaining voice prompts
to complete your request.
IX. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866, under the Regulatory Flexibility Act (5 U.S.C. 601-612),
and under the Unfunded Mandates Reform Act (Public Law 104-4).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). Unless the agency
certifies that the rule is not expected to have a significant economic
impact on a substantial number of small entities, the Regulatory
Flexibility Act requires agencies to analyze regulatory options that
would minimize any significant economic impact of a rule on small
entities. Section 202 of the Unfunded Mandates Reform Act requires that
agencies prepare an assessment of anticipated costs and benefits before
proposing any rule that may result in an expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100 million in any one year (adjusted annually for inflation).
The agency believes that this proposed rule is consistent with the
principles set out in the Executive Order and in these two statutes.
The rule is an economically significant regulatory action as defined by
the Executive Order. With respect to the Regulatory Flexibility Act,
FDA does not believe that this proposal will have a significant effect
on a substantial number of small entities, but recognizes the
uncertainty of its estimates. Therefore, the agency has prepared an
IRFA. FDA is not required to conduct a cost-benefit analysis according
to the Unfunded Mandates Reform Act, because the rule will not impose
any mandates on State, local, or tribal governments, or the private
sector, that will result in an annual expenditure of $100 million or
more.
Furthermore, in accordance with the Small Business Regulatory
Enforcement Fairness Act of 1995 (Public Law 104-121), it has been
determined that this proposed rule would be a major rule for the
purpose of congressional review.
A. Objectives of the Proposed Regulations
The objectives of this proposed regulation are to reduce the
adverse health effects from allergic and foreign body reactions caused
by the NL protein allergens and glove powder found on surgeon's and
patient examination gloves, and from defects in the barrier integrity
and quality of surgeon's and patient examination gloves. The rule will
accomplish these objectives by encouraging manufacturers to limit both
the level of water-extractable protein allowed on gloves and the level
of powder packaged with the gloves, and by requiring the inclusion of
caution statements and the actual level of protein and powder in the
labeling of the gloves. In addition, labeling will include expiration
dates to ensure that the gloves provide adequate barrier protection and
that all medical gloves meet quality standards specified in the special
control guidance referenced elsewhere in this preamble. FDA believes
that by reducing the amount of powder dispersed, these special controls
will reduce the incidence and severity of the allergic reactions caused
by NL proteins without compromising the barrier performance of these
products.
B. Risks of NL Protein Allergic Reactions
FDA recognizes that no systemic epidemiological data exist to
identify the risk of airborne NL protein allergens. However, several
sources indicate that a proportion of the U.S. population have
developed NL sensitivity (Refs. 1 to 8) due to increased exposure to NL
proteins. The increased use of NL gloves with unlimited powder and
protein levels in recent years is believed to contribute to these
adverse events.
FDA's Adverse Experience Reporting System received a total of 330
NL allergy Medical Device Reports (MDR's) associated with medical
gloves for the 12-month period of August 15, 1996, through August 15,
1997 (Ref. 9). These reports included reactions of 435 affected
persons. Despite the lack of representative sampling and the
unconfirmed nature of these reports, FDA believes these data may
provide a reasonable measure of the magnitude of existing risk. Table 1
classifies these reports by type and severity of reaction and shows the
results by number of affected patients.
Table 1.--Number of Patients Reporting to FDA Natural Rubber Latex Allergies Reactions Associated with Medical Gloves Between August 15, 1996, and
August 15, 1997
--------------------------------------------------------------------------------------------------------------------------------------------------------
Type of Allergic Reaction1
-------------------------------------------------------------------------------------------------------
Respiratory Requiring
Systemic Topical (i.e., Systemic Respiratory Aggressive Treatment
Local Topical rash not in area with (e.g., wheezing, (e.g., anaphylaxis,
direct contact) shortness of breath) hospitalization)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Patients Reporting Reaction 20 21 294 100
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\Includes 40 patients with unclassified reactions that were distributed by proportion of reported reactions.
FDA has long been aware that MDR's received by the agency may
account for as little as one percent of the actual events (Ref. 37). If
true, the reports received for allergic reactions associated with
medical gloves could represent as many as 43,500 allergic incidents
during the 12-month period. Because patients may often fail to connect
an allergic incident to use of gloves, FDA believes that this estimate
better reflects the true number of incidents associated with medical
gloves. Given that approximately 22.0 billion gloves (Ref. 38) were
used and 2.16 billion patient visits occurred during that period (Ref.
39), the projected baseline rate of annual allergic reaction incidents
to the total population (0.0001626) at current protein/powder levels
does not seem unreasonable.
Despite the widespread under-reporting cited in the General
Accounting Office (GAO) report, FDA believes that those allergic
reactions that require the most aggressive treatment would be subject
to less under-reporting. For this analysis, FDA has assumed that MDR's
for patients with severe allergic reactions are under-reported by 33
percent, and the other three categories are proportionally
[[Page 41718]]
increased to account for the total under-reporting (Table 2).
Specifically, FDA believes that the 100 reported incidents of
respiratory allergic reactions requiring aggressive treatment (from
Table 1) represent only 150 actual such incidents; not 1,000 as would
be indicated by MDR underreporting. The difference of 850 expected
incidents were distributed to the remaining three categories to result
in 43,500 total incidents. Table 2 also shows the proportion of each
category of reactions reporting long-term and short-term effects, based
on reported lost work-time due to recovery. As expected, only 6 percent
of all topical local reactions were considered long-term, while almost
half of the serious systemic reports were long-term. As discussed in
the benefits section (section IX.F of this document), FDA has assumed,
based on discussions with clinicians, that short-term impacts have a
duration of 1 day and long-term impacts a duration of 2 months.
Table 2 also presents FDA's estimated annual number of each type of
allergic reaction. Although no mortalities were reported in the MDR's
for this period, anaphylaxis carries a risk of mortality that FDA
statisticians place at up to 2 percent, even in health care settings.
Because not all reported serious systemic respiratory reactions were
anaphylaxis, FDA assigned a probability of 0.002 to the adjusted
reports to account for potential fatalities due to anaphylactic shock
caused by NL allergens. (This assumes that only 10 percent of all
respiratory reactions that require aggressive treatment were due to
anaphylaxis.) Given the estimated under-reporting rate, this implies an
annual risk of 0.3 mortalities. FDA expects that by encouraging lower
protein and powder levels for medical gloves, the proportion of
allergic reactions to NL protein allergens will be reduced.
Table 2.--Estimated Number of Patients Experiencing Natural Rubber Latex Allergic Reaction Associated With Medical Gloves From August 15, 1996, to
August 15, 1997, and Proportion Experiencing Short- and Long-Term Effects
--------------------------------------------------------------------------------------------------------------------------------------------------------
Type of Allergic Reaction
---------------------------------------------------------------------------------------------------
Respiratory Requiring Aggressive
Systemic Treatment
Local Topical Systemic Topical Respiratory ---------------------------------------
Other Reactions Mortality
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated Number of Patients Experiencing Reaction 2,588 2,717 38,045 149.7 0.3
Proportion Exhibiting Short-Term Effects (duration 94% 74% 73% 51% NA
of 1 day)
Proportion Exhibiting Long-Term Effects (duration of 6% 26% 27% 49% NA
2 months)
--------------------------------------------------------------------------------------------------------------------------------------------------------
C. Costs of the Proposed Regulation
This section develops estimates of the costs of compliance with the
proposed rule by comparing the expected costs of using surgeon's and
patient examination gloves after the rule is in effect to the costs
that would have been incurred in the absence of the rule. Regulatory
costs occur in four categories. First, the proposed regulation is
expected to accelerate the trend of the glove market towards more
costly, powder-free products. Second, higher average glove purchase
prices will result from the increased cost of gloves with recommended
levels of powder and NL proteins compared to the cost of gloves with
unregulated levels of powder and NL proteins. Third manufacturers will
be required to conduct shelf-life testing on gloves in order to support
expiration dates. Fourth, increased labeling costs will result from the
addition of protein and powder levels and/or expiration dating to each
package of surgeon's and patient examination gloves. Because many of
the estimates are derived from uncertain projections based on limited
data, sensitivity analyses are presented for the most critical
variables and assumptions.
D. Baseline Conditions
1. Annual Number of Gloves
To measure the incremental costs of the regulation against a
baseline of nonregulation, FDA first projected future glove sales. An
estimated 22.0 billion surgeon's and patient examination gloves were
used in the United States in 1997, more than an 11-fold increase from
the approximately 2.0 billion gloves used in 1987 (Ref. 38). The major
contributors to this growth were the recognition of the potential risk
from AIDS infection and the publication of Occupational Safety and
Health Administration (OSHA) regulations requiring barrier protection
for patients and employees exposed to blood borne pathogens (Ref. 40).
FDA assumed that the demand for surgeon's and patient examination
gloves will continue to grow as a result of expected increases in
employment within the health services industry (Standard Industrial
Classification (SIC) 80). The Bureau of Labor Statistics has suggested
that employment within this industry may continue to grow at an annual
rate of 3.9 percent (Ref. 41). Assuming that annual glove use per
employee remains at current levels of approximately 10 pairs per day,
the agency projected that the annual demand for gloves will increase
over the next 10 years at an approximate rate of 3.9 percent per year
(see Table 3). As expected growth in employment or patient health
service visits may also predict future glove use. FDA tested this
assumption by forecasting alternative rates of growth in the
sensitivity analyses presented in section IX.G of this document.
About 65 percent of the current glove market consists of powdered
gloves (Ref. 38), but both health service facilities and glove
manufacturers agree that the market share of powdered gloves is
decreasing rapidly as facilities gain awareness of the potential
adverse health effects associated with NL protein allergens.
Manufacturers, however, explain that powdered gloves will not soon
disappear, because new chlorinators and production lines associated
with powder-free glove production take at least 18 months to
[[Page 41719]]
install and because powdered gloves are still desired by a proportion
of customers. However, manufacturers have estimated that even in the
absence of this regulation, the market share of powder-free gloves
could reach as high as 60 percent within 18 months (Ref. 38). For this
analysis, FDA assumed that, even in the absence of regulation, the
market share for powdered gloves would decrease from the current 65
percent down to 20 percent within 4 years. Concurrently, the market
share for powder-free gloves would increase from 35 percent up to 80
percent over the same period (see Table 3).
Next, FDA estimated that gloves manufactured with synthetic
materials (referred to as synthetic gloves), which are available in
both powdered and powder-free varieties, account for approximately 10
percent of the current market. Most synthetic gloves are manufactured
of vinyl, but other polymers are also used. Synthetic gloves are
generally believed to provide less acceptable barrier protection after
extended use and reduced tactile sensitivity compared to NL. FDA
assumed that, in the absence of regulation, this market share would
increase slightly each year, accounting for 20 percent of the market
within 5 years. Table 3 includes the projected market shares for each
glove type.
Because these projections contain considerable uncertainty, FDA
analyzed several alternative assumptions in the sensitivity analysis
section presented in section IX.G of this document. These scenarios
assume that, in the absence of this rule, the anticipated baseline
market adjustments would take either 10 years, or would not occur at
all.
[[Page 41720]]
Table 3.--Surgeon's and Patient Examination Glove Market Shares--Baseline Estimate
--------------------------------------------------------------------------------------------------------------------------------------------------------
All Surgeon's and Synthetic Gloves Natural Rubber Latex Gloves
Patient -----------------------------------------------------------------------------------------------------------------
Examination
Year Gloves Number of Number of
------------------- Number for Powder- Powdered Total (billion) Number of Powder- Powdered Total (billion)
Number of Gloves Free (billion) (billion) Free (billion) (billion)
(billion)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Current 22.00 0.77 1.43 2.20 6.93 12.87 19.80
1 22.86 1.37 1.37 2.74 10.06 10.06 20.12
2 23.75 1.99 1.33 3.32 12.25 8.17 20.42
3 24.68 2.76 1.18 3.95 14.51 6.22 20.73
4 25.64 3.69 0.92 4.61 16.82 4.20 21.02
5 26.64 4.26 1.07 5.33 17.05 4.26 21.31
6 27.68 4.43 1.11 5.54 17.71 4.43 22.14
7 28.76 4.60 1.15 5.75 18.40 4.60 23.00
8 29.88 4.78 1.20 5.98 19.12 4.78 23.90
9 31.04 4.97 1.24 6.21 19.87 4.97 24.83
10 32.25 5.16 1.29 6.45 20.64 5.16 25.80
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 41721]]
2. Baseline Glove Cost
There are an estimated 198 current marketers of surgeon's and
patient examination gloves in the United States, 10 of which are
domestic manufacturers. Approximately 95 percent of all gloves
purchased in the United States are imported. Although individual
marketers of surgeon's and patient examination gloves operate in a
highly competitive industry and face highly elastic demand curves, the
aggregate market demand for the gloves is assumed to be price
inelastic, because of workplace regulations that require gloves as
barrier protection (Ref. 42). Demand is inelastic if the percentage
increase in price exceeds the percentage decrease in quantity sold.
Consequently, most glove manufacturing cost increases would be passed
on to health care facilities in the form of industry wide price
increases. Although over 95 percent of the manufacturing facilities are
located overseas and the world wide demand for gloves is high, the
United States market dominates global sales. According to Malaysian
manufacturers (Ref. 38), about 80 percent of their gloves are for U.S.
customers.
Current prices of powdered NL gloves average $3.90 per 100, while
powder-free NL gloves average $5.80 per 100 (Ref. 38). Prices were
reported as averages of both surgeon's and patient examination gloves.
The price difference of $1.90 per 100, or almost $.02 per pair, is
attributable to a number of factors, but the predominant reason is the
increased cost of removing former-release powder and/or applying other
lubricants to produce powder-free gloves. The estimated cost for
synthetic gloves is $4.15 per 100 for powdered and $5.03 per 100 for
powder-free. Vinyl gloves account for 90 percent of the synthetic glove
market, with the remaining gloves manufactured from polymers and other
materials.
The nation's annual expenditures for surgeon's and patient
examination gloves are currently estimated at over $1.0 billion. Even
in the absence of regulation, FDA expects that these outlays would
increase to $1.1 billion within 1 year and $1.7 billion within 10
years.
E. Estimation of Compliance Costs
The net costs of compliance with the proposed regulation is the
difference between glove-related costs with and without the regulation.
As noted earlier, industry comments suggest that even in the absence of
this regulation, the market share of powder-free gloves is expected to
increase from 35 percent to about 80 percent over a 4-year period. With
regulation, this trend will be accelerated. Although the market effects
of the rule cannot be known with certainty, FDA estimates that powder-
free gloves will achieve the 80 percent market share 2 years earlier,
or within 2 years of the rule's implementation. In addition,
manufacturers would experience increased costs due to the
recommendation to limit the level of protein to 1,200 g per glove and
the level of powder on NL and synthetic powdered gloves to 120 mg per
glove. These costs would be passed through to health care facilities in
the form of higher prices. Finally, each package of NL gloves must
include labeling that includes protein and powder levels and expiration
dating, and shelf-life testing must support this labeling.
1. Accelerated Market Share for Powder-Free and Synthetic Gloves
Figure 1 illustrates FDA's forecast that powder-free gloves would
gain 80 percent of the surgeon's and patient examination glove market
share within 4 years without regulation and within 2 years with
regulation. Manufacturers have indicated (Ref. 38) that if U.S.
facilities are willing to bear the market price for powder-free gloves,
the powder-free supply to other parts of the world could be shifted to
meet U.S. demand and powder-free market shares could reach as high as
60 percent within 18 months. FDA forecasts that the proposed
regulations will accelerate this trend by reinforcing incentives for
facilities to use powder-free gloves. The shaded area of the chart
measures the expected substitution of powder-free for powdered gloves
caused by facilities choosing to increase use of powder-free gloves in
response to regulatory controls. In addition, FDA projects that the
synthetic market share will rise from 10 to 20 percent within 5 years
without regulation, but within 2 years with regulation. The expected
market shares with the proposed regulation in place are shown in Table
4.
FDA also examined the potential of this regulation to result in
domestic shortages of latex gloves and concluded that there would be
minimal disruption to the U.S. market, as it constitutes such a major
proportion of global sales (up to 80 percent (Ref. 38)). If other
countries do not restrict glove powder, it is possible that the number
of powder-free gloves sold in those markets would fall in the short-
term, while producers adjusted to the demand shift. FDA solicits public
comment on how manufacturers would respond to these altered market
forces.
[[Page 41722]]
Table 4.--Surgeon's and Patient Examination Glove Market Shares with Regulation
--------------------------------------------------------------------------------------------------------------------------------------------------------
Surgeon's and Synthetic Gloves Natural Rubber Latex Gloves
Patient -----------------------------------------------------------------------------------------------------------------
Examination
Year Gloves Number of Number of
------------------- Number of Powder- Powdered Total (billion) Number of Powder- Powdered Total (billion)
Total Number Free (billion) (billion) Free (billion) (billion)
(billion)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Current 22.00 0.77 1.43 2.20 6.93 12.87 19.80
1 22.86 1.37 1.37 2.74 10.06 10.06 20.12
2 23.75 2.47 1.33 3.80 12.97 6.98 19.95
3 24.68 3.95 0.99 4.94 15.79 3.95 19.74
4 25.64 4.10 1.03 5.13 16.41 4.10 20.51
5 26.64 4.26 1.07 5.33 17.05 4.26 21.31
6 27.68 4.43 1.11 5.54 17.71 4.43 22.14
7 28.76 4.60 1.15 5.75 18.40 4.60 23.00
8 29.88 4.78 1.20 5.98 19.12 4.78 23.90
9 31.04 4.97 1.24 6.21 19.87 4.97 24.83
10 32.25 5.16 1.29 6.45 20.64 5.16 25.80
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 41723]]
Because the regulation would not be implemented until 2 years after
publication of the final rule (as shown in Figure 1), no costs would be
incurred in the first year. Moreover, there would be no market share-
associated costs expected after the fourth year, because, by that time,
there would be no difference in the respective market shares of
powdered and powder-free gloves. Based on these assumptions, the
accelerated increase in the powder-free market share results in
increased regulatory costs of $18.9 million in the second year and
$37.3 million in the third year. In the fourth year following
implementation of the rule, costs would fall by $2.9 million due to the
increased use of lower cost synthetic gloves. As shown in Table 5, the
average annualized costs (at a 7 percent discount rate over a 10-year
period) attributable to the accelerated market share for powder-free
gloves are calculated at $6.4 million.
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2. Increased Costs for Powdered Gloves
Limiting the amount of protein and powder permitted on gloves would
increase the production cost and therefore raise the purchase price of
gloves to health care facilities. Although the limits are only
recommended, both the actual and recommended levels of protein and
powder must be included on the product label. Thus, FDA believes it
likely that most glove manufacturers will meet the recommended levels.
According to tests conducted by FDA, current powder levels on powdered
gloves vary between 50 mg and 426 mg per glove. For this analysis, FDA
assumed that a typical powdered NL or synthetic glove contains 260 mg
of powder (based on the observed distribution). Current glove protein
levels vary widely.
Several manufacturers indicated that even minimal recommendations
on powder and protein would result in cost increases of as much as five
percent. These increases would be due to the increased testing and
validation required to ensure that gloves did not exceed limits, the
slower production times resulting from more controlled processes, the
increased inventory damage when stripping gloves from molds, the
increased controls for slurry mixtures, the increased time spent
cleaning or replacing filters and other equipment, and the other costs
associated with more careful controls for the entire manufacturing
process. Manufacturers stated that limiting powder is more a question
of adding controls in the production process than adding new production
lines or facilities. Equipment such as slurries and tumblers are
currently in place, and controls are likely to consist of simply
weighing finished gloves or weighing the slurry filters. However, these
costs are expected to result in increased contract prices for U.S.
health facilities, because there are no substitute products for medical
gloves.
To calculate the costs of alternative permissible powder limits,
FDA estimated an average cost function where the cost of reducing each
mg of powder increases as the proportion of powder remaining on the
manufactured glove decreases. Because current powdered NL gloves cost
$3.90 per 100 and powder-free gloves cost $5.80 per 100, FDA calculated
that the $1.90 cost of removing the average 260 mg of powder per 100
gloves is about $0.0073 per mg ($1.90/260 mg). If the cost function
were linear, the incremental cost of reducing powder levels by 140 mg
(i.e., from the current average 260 mg of powder to the recommended
level of 120 mg) would be calculated as $0.0073 times 140, or $1.022
per 100 gloves. However, FDA believes that the relationship is unlikely
to be linear as several manufacturers indicated that significant
control costs would be needed to achieve even modest reductions in
powder levels, after which average costs would rise slowly and then
more steeply as powder concentrations approach zero. Such a functional
form is typical of many manufacturing processes and illustrated by the
solid sigmoid curve shown in Figure 2 (Refs. 44 and 45). A cost
equation fitting this illustrated functional form is:
Y = 0.00365 + 0.0292(X - 0.5)3
Where:
Y equals the cost per mg removed per 100 gloves, and
X equals the proportion of powder removed.
Figure 2 includes the estimated cost function for removing powder
from synthetic gloves as the hashed line. The expected costs per mg
removed are less than for NL gloves because the current price
difference between powder-free and powdered synthetic gloves ($0.88 per
100) is less than the difference for NL gloves ($1.90 per 100).
On the assumption that these equations approximate the actual
relationships, FDA estimates that the cost of limiting powder to 120 mg
per 100 NL gloves is about $0.003652 per mg removed, or about $0.511
per 100 NL gloves. For synthetic gloves, the estimated costs are
$0.001693 per mg removed, or about $0.237 per 100 synthetic gloves. As
shown in Figure 3, the control costs rise sharply for limits below 120
mg. For example, a proposed powder limit of 100 mg per NL and synthetic
glove would result in costs over 15 percent greater than the proposed
120 mg limit. Because of the control processes required, FDA assumes
that the previous estimates would also account for the cost of limiting
protein levels for NL gloves.
Table 5 shows these estimated costs over a 10-year period. Because
the regulation is expected to be implemented 2 years after publication
of the final rule, no increased powdered glove costs are incurred in
the first year. In year 2, the higher prices for powdered NL gloves
result in increased costs of $35.7 million. In year 3, these costs fall
to $20.2 million. Thereafter, the yearly incremental compliance costs
associated with NL glove powder and protein limits vary between $21.0
and $26.4 million. The average annualized contribution of this cost
category (at a 7 percent discount rate over 10 years) equals $21.4
million.
Within 2 years, higher costs for powdered synthetic gloves will
equal $3.1 million. The yearly incremental compliance cost for powdered
synthetic gloves is expected to decrease to $2.3 million in year 3, and
then increase slightly each year throughout the evaluation period. The
average annualized contribution of this cost category (at a 7 percent
discount rate over 10 years) equals $2.4 million.
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Table 5.--Compliance Costs Over 10-Year Period
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cost of Increased Cost of Cost of Shelf-Life Testing
Accelerated Powdered NRL Synthetic -------------------------------- Labeling Cost Total Cost ($
Year Market Share Gloves ($ Gloves ($ Test Cost ($ Lost Inventory ($ million) million)
($ million) million) million) million) ($ million)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 0.0 0.0 0.0 0.0 0.0 0.0 0.0
2 18.9 35.7 3.1 1.6 3.0 1.6 63.9
3 37.3 20.2 2.3 1.2 1.3 0.6 62.9
4 2.9 21.0 2.4 1.2 1.1 0.5 23.3
5 0.0 21.8 2.5 1.3 1.4 0.7 27.7
6 0.0 22.6 2.6 1.3 1.2 0.5 28.2
7 0.0 23.5 2.7 1.5 1.1 0.6 29.4
8 0.0 24.4 2.8 1.5 1.6 0.8 31.1
9 0.0 25.5 2.9 1.4 1.3 0.6 31.7
10 0.0 26.4 43.1 1.5 1.3 0.6 32.9
Total 53.3 221.0 24.6 12.5 13.3 6.5 331.2
Average Annualized (7 percent discount 6.4 21.4 2.4 1.2 1.3 0.7 33.4
rate)
--------------------------------------------------------------------------------------------------------------------------------------------------------
3. Costs of Shelf-life Testing and Inventory Loss
The proposed regulation will require manufacturers of patient
examination and surgical gloves to develop and affix labeling to their
products that will include expiration dating. To ensure that medical
gloves will maintain adequate barrier protection for the entire stated
period, manufacturers will likely conduct real-time shelf-life testing
of gloves. The compliance costs of this testing includes both the
actual cost of conducting laboratory tests, and the lost revenues of
inventory lost due to sampling.
a. Shelf-life testing. FDA contracted with the Eastern Research
Group (ERG), an economic consulting firm, to contact domestic and
foreign glove manufacturers and research laboratories to determine the
expected unit costs of shelf-life testing, and to determine current
levels of industry compliance. ERG developed a cost model that
estimated compliance costs according to the size of the manufacturer
(Ref. 45a).
ERG estimated that the expected marketing life for each glove model
is approximately 3 years. During this period, stability testing is
likely to occur at 6-month, 1-year, 2-year, and 3-year intervals. The
actual tests were assumed to consist of a combination of real-time and
accelerated tests. Overall, the estimated costs of a shelf-life test
was found to approximate $265 for foreign tests and $865 for domestic
tests. (The difference in testing costs are attributable to the lower
purchasing power parity per capita in foreign countries that produce
medical gloves.)
As explained in Ref. 45a, almost 3,000 separate glove models are
currently produced by 198 separate manufacturers. Only 160 models are
marketed by the 10 domestic manufacturers. Given the expected growth in
the demand for gloves, and the shift to powder-free and synthetic glove
models, the estimated costs of shelf-life testing varies with FDA's
projected number of future glove models. It was assumed that new models
would have two shelf-life tests during the year of introduction while
models already marketed would have one annual shelf-life test. Finally,
ERG and industry sources estimated the current level of shelf-life
testing based on both domestic/foreign and size characteristics.
Based on these assumptions, the greatest increase in shelf-life
testing is expected during year 2, with over 6,000 additional tests due
to this proposed regulation. The total cost of conducting these tests
equals $1.6 million, of which $0.1 million is incurred by domestic
glove manufacturers. Amortizing the annual testing costs by 7 percent
over 10 years, the average annualized costs of conducting the required
shelf-life tests equals $1.2 million.
b. Inventory losses. As part of these tests, manufacturers will be
required to set inventory aside from which test samples will be
selected. ERG, with discussions with laboratories and manufacturers,
has determined that small glove manufacturers would be likely to set
10,000 gloves per model aside for shelf-life testing while large
manufacturers would set 30,000 gloves per model. Given the industry
characteristics as discussed in Ref. 45a, this implies that over 115
million gloves would be set aside in year 2. In addition, the relative
market shares of synthetic, NL, powdered and powder-free gloves is
expected to change over time which will affect the average lost revenue
per sample. FDA analyzed the impact of this future inventory loss and
found that during year 2 of the evaluation period, the value of lost
inventory for testing is expected to equal over $3.0 million for the
entire industry. The average annualized cost of this lost inventory (as
shown in Table 5) at 7 percent over 10 years equals $1.3 million.
4. Costs of Labeling. ERG also developed estimates of the costs of
developing the proposed enhanced labeling for gloves. These estimates
included the costs of artwork, design, regulatory review, production
and application, as shown in Ref. 45a. Overall, the average cost of
developing a label for a foreign medical glove model was estimated to
equal $411, while a domestic model would cost $1,444. The number of
domestic and foreign glove models expected to be introduced throughout
the 10-year evaluation period and the market characteristics as
discussed in Ref. 45a, indicate that the costs of labeling will equal
$1.4 million in year 2. These yearly costs will then decrease to as low
as $0.3 million by the 10th year. The average annualized cost of
developing and producing labeling for medical gloves attributable to
this proposed regulation is estimated to equal $0.7 million, as shown
in Table 5.
5. Total Incremental Costs
Figure 4 presents the estimated annual expenditures imposed by the
proposed rule. Overall, costs of $63.9 million are expected in year 2.
These costs decreased to $62.9 million in year 3, and then decrease to
$23.3 million in the third year. Costs are expected to
[[Page 41729]]
increase slightly for each subsequent year. Most of the incremental
costs, as shown in Table 5, are due to increases in glove costs
(powdered NL and synthetic gloves with limited powder levels). The
estimated average annualized cost over a 10-year period (at a 7 percent
discount rate) is $33.4 million.
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F. Benefits of the Proposed Regulations
1. Expected Risk Reduction
As discussed previously, the estimated annual proportion of the
population (0.0001626) that experiences allergic reactions associated
with medical gloves is assumed to be related to the prevalence of
environmental protein and powder. Consequently, reducing protein and
powder levels would reduce the proportion of the population expected to
experience an allergic reaction. Decreases would be expected in NL
sensitization as well as allergic reactions.
To estimate this relationship, FDA assumed that the proportion of
the population affected would vary directly with the total quantity of
environmental protein/powder. The annual level of environmental
protein/powder was calculated from the expected annual number of
powdered NL gloves multiplied by the average level of powder per glove.
The current market share of powdered NL gloves (Table 3) and the
current average level of glove powder (260 mg) yield an aggregate
estimate of 3.346 billion g of protein/powder. This quantity of
protein/powder is associated with allergic reactions in 0.0001626 of
the population, or 0.000049 reactions per billion g. If the
relationship between the number of reactions and the quantity of
protein/powder were linear, the model implies a 30 percent reduction in
allergic prevalence for each billion g of powder reduction.
Alternatively, the function relationship may take other forms, and FDA
suspects that the increasing number of reports of allergic reactions to
NL in recent years likely indicates a nonlinear relationship. Figure 5
presents a polynomial projection that FDA tentatively adopts as a
plausible estimate for this analysis. The equation of the function
illustrated in Figure 5 is:
Y = (0.0000143)X2
Where:
Y equals the proportion of the population with NL allergic
reactions, and
X equals the level of environmental protein/powder (in billions of
g).
Although the exact relationship is speculative, FDA believes that
an exponential relationship as shown in Figure 5 is most likely. As
shown in section IX.G of this document, the agency's sensitivity
analysis indicates that due to the rising baseline projection, this
polynomial projection yields smaller benefits than a linear model.
Table 6 shows the expected number of allergic reactions associated
with protein/powder levels with and without the proposed regulation.
The protein/powder amounts are derived from the expected numbers of
powdered NL gloves shown in Tables 3 and 4, the current average glove
powder level (260 mg per glove), and the new recommended glove powder
level (120 mg per glove). Powdered synthetic gloves do not affect this
relationship because no NL proteins are associated with those products.
Table 6 shows that in the absence of the proposed regulation, the
expected increased market share of powder-free gloves would reduce the
number of annual allergic reactions attributable to medical gloves from
43,500 to only 4,800 within 4 years. With the proposed regulation in
place, the expected number of allergic reactions would decrease to only
900 within 3 years, and consistently remain several thousand fewer than
those expected without regulations.
2. Benefits
To estimate the potential benefits of the proposed rule, the number
of reduced expected allergic reactions shown in Table 6 were
distributed in proportion to the categories shown in Table 2. Assuming
that the decreased number of reactions would not modify the severity
distribution as reported in the MDR's (as adjusted to account for
under-reporting), the proposed regulation would reduce annual allergic
reactions by 15,100 within 2 years. The characteristics of these second
year avoided reactions are shown in the first four columns of Table 7.
[[Page 41733]]
Table 6.--Expected Number of Allergic Reactions
--------------------------------------------------------------------------------------------------------------------------------------------------------
In the Absence of Regulation1 With Regulation2
------------------------------------------------------------------------------------------------------------------ Difference in
Number of Number of Allergic
Year Powdered Natural Level of Powder Estimated Number Powdered Natural Level of Powder Estimated Number Reactions with
Rubber Latex (billion g) of Allergic Rubber Latex (billion g) of Allergic Regulation (000)
Gloves (billion) Reactions (000) Gloves (billion) Reactions (000)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Current 12.87 3.35 43.5 - NA - - NA - - NA - - NA -
1 10.06 2.62 26.9 10.06 2.62 26.9 0.0
2 8.17 2.13 17.9 6.98 0.84 2.8 (15.1)
3 6.22 1.62 10.4 3.95 0.47 0.9 (9.5)
4 4.20 1.09 4.8 4.10 0.49 1.0 (3.8)
5 4.26 1.11 5.0 4.26 0.51 1.1 (3.9)
6 4.43 1.15 5.4 4.43 0.53 1.2 (4.3)
7 4.60 1.20 5.9 4.60 0.55 1.3 (4.7)
8 4.78 1.24 6.4 4.78 0.57 1.4 (5.1)
9 4.97 1.29 7.0 4.97 0.60 1.5 (5.5)
10 5.16 1.34 7.6 5.16 0.62 1.6 (6.0)
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Powder level of 0.260 g per glove
\2\ Powder level of 0.120 g per glove
[[Page 41734]]
There is no methodology that permits a precise assignment of
monetary values to regulatory health benefits. However, one approach
recently described in the health economics literature (Refs. 47 and 48)
combines relative states of well-being with observed willingness to pay
for risk avoidance. FDA adopted this methodology and used the Kaplan-
Bush Indices of Well-Being (Refs. 49 and 50) to estimate the value of
reducing the number of allergic reactions.
The first step was to assign to each category of reaction a
functional index based on mobility/physical/sociability scales. The
index of relative well-being (as described in Refs. 49 and 50) utilize
functionality levels as a basis for estimating well-being. The
functionality scales are described in Table 8. Baseline levels of well-
being were defined for 43 distinct combinations of mobility, physical
activity, and sociability. For example, if a hypothetical patient could
drive a car and use transportation without help (mobility equals 5),
could walk without a physical problem (physical activity equals 4), and
had no morbidity symptoms or problem, then this patient would have an
assigned well-being of 1.0000. However, if this hypothetical patient
could perform all of these activities, but suffered from any morbidity
(including requiring eyeglasses), the assigned baseline level of well-
being was found to equal 0.7433. The baseline levels of well-being are
then adjusted, either up or down, based on the predominant symptom or
problem that is on-going. This methodology is described in detail in
Refs. 49 and 50. For example, a local topical reaction is unlikely to
interfere with normal activities, such as driving a car or performing
housework. A patient suffering from a local topical reaction is
expected to continue to be able to interact with others in a normal
manner. This functional state is assigned a relative well-being rate of
0.7433, or roughly 74 percent of optimum well-being. This baseline
functional index is based on the prevailing medical problem. In this
case, the problem/symptom is identified as ``burning and/or itching of
skin'' and the 0.0171 value for this problem/symptom (from Refs. 49 and
50) is added to the basic functional state. Thus, by combining these
indices, a person suffering a local, topical allergic reaction is
expected to have a relative well-being of 0.7604. Each of the
categories of reactions have been assigned values, as included in Table
7. Mortalities are valued as 0.0000.
Next, optimum values of well-being were derived for both short-term
durations (1 day) and long-term durations (2 months). The economic
literature includes many attempts to quantify society's willingness-to-
pay (WTP) to avoid risks. Various methodologies have resulted in an
average value of approximately $5.0 million as a measure of the WTP to
avoid a statistical death (Refs. 51, 52, and 53). By amortizing this
value to account for life expectancy and expected disability-days
(Refs. 54 and 55), FDA estimates that a quality-adjusted life-year
(QALY) has an approximate value of $373,000. Using this estimate, the
expected value of a quality-adjusted life-day is approximately $1,022
and the expected value of two quality-adjusted life-months is $62,166.
The relative wellness values for each category shown in Table 7
represent the proportion of wellness relative to an optimum level. The
willingness of society to pay for avoiding each incident were reflected
as the difference between the wellness state and an optimum level
multiplied by the duration of the event. For example, a local topical
allergic reaction has an expected wellness value of 0.7604, or 0.2396
below optimum. This difference is used to calculate the amount that
society is willing to pay to avoid a reaction of this type.
[[Page 41735]]
Table 7.--Characteristics of Reductions in Second Year Allergic Reactions
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Number of Value per Value per
Category Number of Avoided Avoided Problem/ Value per Value per Short-Term Long-Term
of Avoided Short-Term Long-Term Functional Symptom Relative Short-Term Long-Term Reaction Reaction Total Value
Reaction Reactions Reactions Reactions State\1\ Weight\2\ Wellness Reaction Reaction ($ Avoided ($ Avoided ($ ($ 000)
(000) (000) (000) 000) 000) 000)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Local 0.89 0.84 0.05 0.7433 0.0171 0.7604 245 14,900 205 794 999
Topical
Systemic 0.94 0.69 0.24 0.6065 0.0171 0.6236 385 23,400 267 5,709 5,976
Topical
Systemic 13.24 9.66 3.57 0.525 -0.0075 0.5175 493 30,000 4,764 107,194 111,958
Respira
tory
Respirat 0.05 0.03 0.03 0.5284 -0.1507 0.3777 636 38,700 17 972 989
ory
Requiri
ng
Aggress
ive
Treatme
nt
Mortalit 0.00 NA NA 0 0 0 NA NA NA NA 514\3\
y
Totals 15.11 11.22 3.90 120,436
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Functional states: Mobility - 5; Physical activity - 4; Social - 5 = 0.7433
Mobility - 4; Physical activity - 4; Social - .4 = 0.6065
Mobility - 4; Physical activity - 3; Social - 3 = 0.525
Mobility - 4; Physical activity - 1; Social - 2 = 0.5284
Mortality = 0.0000
\2\ Problem/Symptom Adjustments:
Burning or itching rash on body = +0.0171
Wheezing or shortness of breath = -0.0075
Loss of consciousness, fainting = -0.1507
\3\ Value per mortality is $5 million. May not add due to rounding.
[[Page 41736]]
For 1 day, this value is $245 ($1,022 x .2396) and for 2 months, the
estimated value per reaction is $14,895. The derived values for each of
the reaction categories and terms are shown in Table 7.
The values for each category, when multiplied by the number of
decreased reactions expected due to this regulation, result in the
expected annual benefit. Table 7 includes this estimate for only the
second evaluation year. It indicates that society would be willing to
pay a value of approximately $120.4 million to avoid 15,100 allergic
reactions to NL protein.
Taking these steps for each year in the evaluation period yields
estimates of the willingness to pay to avoid these reactions as shown
in Table 9. The undiscounted benefits equal $120.4 million in year 2,
then decrease to $30.4 million in year 4. Between years 4 and 10, the
estimated annual benefit increases to a value of $47.5 million. The
estimated annualized benefit of avoiding these reactions is $46.9
million.
FDA notes that other potential benefits, such as the avoidance of
third-party payments as a result of treating fewer allergic reactions,
the value of reduced anxiety due to lowering NL sensitization, the
reduction in defects in glove barrier integrity, and the reduction in
other foreign body reactions caused by glove powder have not been
quantified at this time. FDA recognizes the considerable uncertainty of
all of these estimates, however, and requests comment on all of the
data and assumptions.
Table 8.--Description of Inputs to Functionality Levels
----------------------------------------------------------------------------------------------------------------
Mobility Physical Activity Social Activity
----------------------------------------------------------------------------------------------------------------
5-Drove car and used transportation 5-Did work, school, or housework and
without help other activities
4-Did not drive, needed help with 4-Walked without physical problem 4-Did work, school, or housework,
transportation but other activities limited
3-In house 3-Walked with physical problem 3-Limited in work, school or
housework
2-In hospital 2-Moved own wheelchair without help 2-Performed self-care
1-In special unit 1-In bed or chair 1-Had help in self-care
----------------------------------------------------------------------------------------------------------------
Source: Kaplan, Bush, et. al. (Refs. 49 and 50)
Table 9.--Expected Benefit of Decreased NRL Allergic Reactions Due to Regulation
----------------------------------------------------------------------------------------------------------------
Net Present Value of
Year Decreased Reactions (000) Value of Decreased Reactions Decreased Reactions ($
($ million) millions)
----------------------------------------------------------------------------------------------------------------
Current NA NA NA
1 0.0 NA NA
2 (15.1) 120.4 105.2
3 (9.5) 76.0 62.0
4 (3.8) 30.4 23.2
5 (3.9) 31.1 22.2
6 (4.3) 34.0 22.7
7 (4.7) 37.1 23.1
8 (5.1) 40.3 23.4
9 (5.5) 43.7 23.8
10 (6.0) 47.5 24.2
Average Annual 46.9
Benefit ($
million)
----------------------------------------------------------------------------------------------------------------
G. Sensitivity Analyses
FDA examined the impact of various assumptions that affect future
conditions. These analyses are as follows:
1. Growth Rate of the Demand for Surgical and Patient Examination
Gloves
FDA used 1992 to 1994 rates of employment growth within the health
services industry (SIC 80) to project a 3.9 percent annual growth in
the future demand for surgical gloves (Ref. 41). However, more recent
data obtained for the period up to 1998 suggest the more modest growth
rate of 2.7 percent for this industry (Ref. 55a). Examining the
expected costs and benefits after lowering the expected growth for
surgical and patient examination gloves to 2.7 percent indicates that
average annual costs decrease from $33.4 to $31.5 million and average
annual benefits decrease from $46.9 to $42.1 million. If the forecast
relied instead on the growth of total employment hours in the health
service industry (Ref. 55b), the rate in recent years has been
approximately 2.0 percent. Using this rate as the expected growth rate
for surgical and patient examination gloves results in average annual
costs of $30.4 million and average annual benefits of $39.6 million.
FDA notes that under the alternative assumptions, both costs and
benefits are lower than under the scenario presented earlier, but the
regulation would still be justified.
2. Market Shares of Powder-Free and Synthetic Gloves
FDA has estimated that in the absence of regulation, within 4
years, 80 percent of the glove market would consist of powder-free
gloves; and within 5 years, 20 percent of all gloves would be
manufactured of synthetic material. The proposed regulation is expected
to accelerate these trends to within 2 years of implementation.
To examine the sensitivity of these assumptions, FDA calculated the
costs and benefits of the rule assuming that, in the absence of
regulation, it would take 10 years rather than 4 years for powder-free
gloves to account for 80 percent of the market and 10 years rather than
5 years for synthetic gloves to account for 20 percent of the market.
The expected average annual costs in this scenario equal $72.7 million,
and the average annual benefits equal $112.1 million. FDA also examined
the impact of assuming no expected change in baseline market share from
the first implementation year, in the absence of regulation. In this
case, the average
[[Page 41737]]
annual costs equal $135.7 million, and the average annual benefits
equal $283.2 million.
3. Linear Relationship between Environmental Protein/Powder and
Allergic Reactions
FDA expects that an exponential relationship exists between
protein/powder levels and allergic reactions, but the agency also
examined the effect of a linear relationship. The linear model
increased the expected average annual benefit of reducing exposure from
$46.9 million to $75.7 million, by increasing the number of avoided
incidents as protein/powder levels were decreased. Table 9 indicates
the magnitude of the expected decrease in NL reactions using the
expected exponential relationship. A total of 57,900 avoided reactions
were forecast. If the actual relationship were linear, the rule would
be expected to result in the avoidance of 88,100 incidents over the
same period.
4. Conclusion
FDA has tested several key assumptions used in the analysis of
impacts. Each simulation resulted in estimated benefits exceeding
costs. Nonetheless, FDA recognizes the significant uncertainty in this
analysis and requests any additional information that would improve the
projections.
H. Small Business Impact
1. Initial Regulatory Flexibility Analysis
FDA believes that the proposed regulation will not have a
significant impact on a substantial number of small entities, but
conducted an initial regulatory flexibility analysis (IRFA) to ensure
that impacts on small entities were assessed and to alert any
potentially impacted entities to the opportunity to submit comments to
the agency.
2. Description of Impact
The objectives of the proposed regulation are to reduce the adverse
health effects attributable to allergic and foreign body reactions from
NL allergens and glove powder and to defects in barrier protection and
quality of surgeon's and patient examination gloves. The proposed
regulation will accomplish these objectives by reclassifying surgeon's
and patient examination gloves into class II products, and requiring
product labeling. In addition, the proposed regulation recommends
protein and powder levels for surgeon's and patient examination gloves.
FDA's statutory authority for the proposed rulemaking under the act is
discussed in section II of this document.
Two separate industries will be affected by the proposed
regulation: Manufacturers of surgeon's and patient examination gloves
(found in Standard Industrial Classification 3842, Medical Equipment
and Supplies) and Health Facilities (found in SIC 80).
Table 10.--Non-Health Care Industries That Use Gloves as Protection
------------------------------------------------------------------------
Number of Number of
Industry Sector SIC Code Establishments Employees
------------------------------------------------------------------------
Government 9,461 10,893 56,345
Residential Care 836 2,423 NA
Personal Services 7,362 1,348 163,477
Funeral Services 726 19,890 57,013
Health Units in NA 202,540 178,732
Industry
Non-Health 8,221 1,453 89,159
Research
Laboratories
Linen Services 7,218 1,250 50,000
Medical Equipment 384 1,076 6,185
Repair
Law Enforcement 9,221 4,946 341,546
Fire and Rescue 9,224 3,174 252,048
Lifesaving 9,229 100 5,000
Schools 9,411 6,321 4,132
Waste Removal 4,953 940 13,300
------------------------------------------------------------------------
Source: OSHA (Ref. 40)
FDA considered the potential impact of the proposed regulation on a
number of nonhealth industries, but found that any impact would be
insignificant. When OSHA issued its final regulations on blood-borne
pathogens (Ref. 40), it considered a wide-range of establishments
including: Law enforcement agencies, schools, linen services, and
funeral parlors (see Table 10). While a substantial number of these
establishments are small under the Small Business Administration
definition, this proposed regulation does not require the use of FDA-
regulated medical gloves at these sites. OSHA assumed that many of
these industries would use utility gloves or consumer-grade gloves to
provide barrier protection. For example, janitorial services and waste
removal establishments were assumed to use utility work gloves, while
law enforcement agencies were expected to use consumer-grade vinyl
gloves. Few industries or establishments were expected to use FDA-
regulated medical gloves in nonmedical settings. However, even in
settings where medical gloves may be used, the frequency of glove usage
was much less in these sectors. OSHA estimated that an average school
would use approximately eight pairs of gloves per day. In contrast, a
small physician/dental office would be expected to use 30 pairs of
gloves per day. Both the relative frequency of glove use and the
concentration of FDA-regulated medical gloves convinced FDA to focus on
the Health Services Industry (Table 11) as the area of largest
potential impact.
Table 11.--Establishment and Employment in the Health Services1
----------------------------------------------------------------------------------------------------------------
Number of Number of Average Number of
Establishments and (Standard Industrial Classification Establishments Employees Employees per
Codes) (thousand) (thousand) Establishment
----------------------------------------------------------------------------------------------------------------
Total Health Services (80) 1,030.0 11,000.0 10.7
[[Page 41738]]
Clinics and Offices of MD's (801) 328.9 1,908.4 5.8
Clinics and Offices of Dentists (802) 138.5 709.4 5.1
Clinics and Offices of Osteopathy (803) 18.4 60.6 3.3
Other Health Practitioners (804) 243.0 483.6 2.0
Nursing Facilities (805) 57.7 2,011.8 34.9
Hospitals (806) 7.1 4,496.5 633.3
Medical/Dental Laboratories (807) 29.4 229.3 7.8
Home Health Services (808) 99.9 743.9 7.4
Other Allied Services (809) 107.7 356.5 3.3
----------------------------------------------------------------------------------------------------------------
\1\ 1992 Census of Service Industries and Bureau of Labor Statistics projections of employment trends in the
health services industries.
Glove manufacturers will be affected by labeling that requires
additional warnings and statements concerning recommended protein and
powder limits, testing and validation measures that are necessary to
ensure the accuracy of this information, and limitations on the use of
powder for mold release. Health facilities will face increased
expenditures for surgeon's and patient examination gloves by either
shifting from powdered gloves to more expensive powder-free products or
continuing to use powdered gloves that cost more due to production cost
increases.
Manufacturers classified within the four-digit SIC code 3842 are
typically small. Only 38 percent of all establishments had 20 or more
employees in 1992 (Ref. 56), and companies had an average of 1.12
separate establishments. The manufacturers are highly specialized, with
over 92 percent of their products considered within the medical
equipment and supplies industry, and 94 percent of all medical
equipment and supplies manufactured by these firms. The Small Business
Administration classifies as small any entity within this industry with
500 or fewer employees (Ref. 57), capturing the majority of
establishments. However, the affected manufacturers of surgeon's and
patient examination gloves have some product-specific characteristics
that distinguish them from the average establishment in this industry.
FDA's registration system for medical devices shows 198
manufacturers of surgeon's and patient examination gloves, the vast
majority of which are located outside the United States and operate in
a world-wide market, although the U.S. constitutes the most significant
regional market. FDA examined the records of current manufacturers and
identified 10 domestic manufacturers of surgeon's and patient
examination gloves out of the total 198 marketers. Only 1 of these 10
domestic manufacturers reported employment of fewer than 1,200
employees. However, FDA acknowledges that additional small domestic
manufacturers could enter the market in the future.
The main impacts of the proposed regulations on small manufacturers
would occur if the manufacturer had to conduct additional validation
tests to ensure the accuracy of protein and powder levels displayed on
the product labeling and if increased inventory loss or slower
production times occurred due to limited uses of powder as a mold
release. Although FDA does not stipulate the acceptable validation test
method in the regulation, and is soliciting comments on this issue in
order to minimize its impact, it is possible that a chemist would be
required on a contract basis to ensure that the actual levels of
protein and powder matched the levels on the label. FDA is working with
industry groups to ensure that an acceptable and reliable test method
is chosen. Despite this outreach, the selected test method could impose
additional and disparate costs to a small manufacturer. Similarly,
increased inventory loss because of tearing in the production process
due to limited powder would affect small production runs to a greater
degree than large production runs. Discussions with manufacturers have
indicated that any additional validation testing or negative impacts on
production capability could increase the production costs of medical
gloves by 5 percent or more.
As discussed earlier in the analysis of impacts section (section
IX.D of this document), the demand for medical gloves is highly price
inelastic due to the regulatory requirement for health facilities (SIC
80) to provide barrier protection (Ref. 40) and the lack of substitute
products (Ref. 42). The characteristics of the medical glove market
therefore indicate that production cost increases resulting from the
proposed rule are likely to be passed through in the form of higher
contract prices. In addition, many facilities are currently accepting
increased glove prices by establishing powder-free environments in the
absence of any rule-making. Thus, production cost increases by glove
manufacturers are likely to be offset by revenue gains for these same
manufacturers, with the result of shifting the cost impact to the
health facilities.
Small health facilities therefore will also bear some regulatory
impact. The Small Business Administration has defined as small any
``for-profit'' health facility with annual revenues of $5 million or
less (Ref. 57). Most hospitals and nursing facilities would be
considered large under this definition. However, nonprofit facilities
not dominant in their field are also considered small entities.
Industry characteristics of the health facility industry are shown in
Table 11. Approximately 95 percent of the hospitals and nursing
facilities are considered as small entities (6,700 hospitals and 54,800
nursing facilities).
FDA examined the potential impact of the proposed regulations on
two types of health care user facilities: Small physician/dental
facilities and small hospitals. A small physician or dental facility
may use as many as 25,000 (based on 120 patient visits per week) gloves
each year. If the facility substitutes powder-free for powdered gloves
as a result of this regulation, costs would increase by $475 per year
((25,000/100) x $1.90).
Similarly, a small hospital is also likely to experience increased
annual costs of acquiring gloves. An extremely small hospital with only
6 beds and a staff of 11 might use about 22,000 gloves annually. If the
facility faced increased glove costs, the total increase in costs could
amount to about $950.
FDA wishes to collect additional information on the nature of the
impacts on small entities in order to ensure that all such impacts are
noted. In addition,
[[Page 41739]]
other public facilities such as prisons, and police or fire departments
may face higher glove prices due to this regulation. FDA does not
expect these costs to be significant, but solicits comments on this
potential burden.
3. Analysis of Alternatives
FDA has examined and rejected the following alternatives to the
proposed rule:(1) Banning powdered gloves; (2) mandating protein and
powder levels on medical gloves; (3) requiring all users of powdered
gloves to comply with restrictions on distribution and use; (4)
retaining the class I classification for all (or some) of the medical
gloves; and (5) excluding powdered synthetic gloves from this
rulemaking; and (6) providing for a shorter or longer compliance
period. FDA has rejected the alternatives at this time for the
following reasons:
Alternative 1: A ban of all powdered medical gloves has been
requested in a citizen petition submitted to FDA. FDA considered
banning powdered gloves because that action would meet the stated
objective of eliminating airborne powder and greatly reducing exposure
to airborne allergens associated with the use of medical gloves.
However, FDA did not select this alternative because a ban would not
address exposure to NL allergens from medical gloves with high levels
of NL proteins. Moreover, such a ban of powdered gloves might
compromise the availability of high quality medical gloves and greatly
increase the annual costs by almost as much as $64 million over the
selected alternative.
Alternative 2: FDA also considered mandating powder and protein
levels for medical gloves because this alternative would accomplish the
stated objectives more completely than banning. FDA rejected mandating
powder and protein levels for medical gloves because the agency
believes that the increased regulatory flexibility of the proposed rule
may reduce the costs of compliance by allowing for more efficient
methods of reaching the goal. Inventories could be lowered and industry
capacity could be assured. Mandating specific protein and powder
levels, as well as the acceptable test method, may preclude all parties
from developing a more efficient system. In addition, FDA inspectional
and compliance costs are minimized by relying on recommended levels of
powder and protein. By ensuring user access to relevant information,
the agency believes that users will move the market to a more efficient
level.
Alternative 3: FDA considered restricting the distribution and use
of powdered NRL or synthetic material medical gloves by requiring that
establishments using powdered gloves establish and maintain written
procedures for selecting, purchasing and distributing gloves. FDA
further considered restricting the distribution and use of powdered NRL
or synthetic material medical gloves by requiring establishments using
powdered gloves with more than the recommended powder levels to
establish and maintain written procedures to evaluate, monitor and
control airborne particulate matter at the point of use, through the
use of an externally exhausted air handling system, HEPA filtration, or
other system. FDA believes that these restrictions would reduce the
risk of adverse foreign body and allergic reactions associated with
powdered glove use. However, the extent of the expected reduction is
uncertain. The expected costs of complying with these restrictions was
estimated to be over $21 million. Furthermore, any such workplace
restrictions may impede or preempt the authority of OSHA to regulate
gloves and glove powder in the workplace.
Before rejecting this alternative, the agency had examined the
feasibility of exempting small facilities from the requirements of
developing written procedures and air quality measures. Based on the
expectation that small establishments with 10 or fewer employees would
be able to communicate and control risks associated with powdered
medical easier than larger institutions. Exempting small medical
facilities from these controls lowers the added costs to $6.6 million.
However, FDA rejected this alternative because the expected benefits of
restricting glove use remained uncertain, and the potential overlap of
authority with OSHA would still exist.
Alternative 4: FDA considered retaining the class I classification
for all or some of the medical gloves. This alternative was rejected
because it did not meet the stated objectives. In light of new
information concerning barrier integrity, degradation of quality during
storage, contamination concerns and concerns about exposure to foreign
bodies and allergens, FDA found that general controls are no longer
sufficient to provide reasonable assurances of the safety and
effectiveness of medical gloves. Moreover, such concerns were not
limited to only powdered gloves. To require a device to meet special
controls as well as general controls, a device must be classified (or
reclassified) into class II. Consequently, although compliance costs
would have been reduced by this alternative, retaining some or all
gloves as class I devices was rejected.
Alternative 5: Alternative 5 (excluding powdered synthetic gloves
for this rulemaking) was considered in order to reduce cost by as much
as $2.4 million per year. FDA rejected this alternative because it
would not meet the stated objective of the applicable statutes. While
synthetic gloves do not contain NL proteins, FDA is concerned about
foreign body reactions caused by glove powder. These reactions occur
whether the powder is present on a NRL or synthetic glove.
Consequently, FDA is rejecting exempting powdered synthetic gloves from
this regulation.
Alternative 6: FDA considered providing a shorter compliance period
for implementation of the regulation. A compliance period of 90 days or
1 year would significantly increase the expected benefits of the rule
by decreasing the number of annual allergic reactions. FDA estimates
that a 90-day or 1-year implementation period would result in between
3,300 and 3,600 fewer annual allergic reactions to NL proteins than the
number expected with the selected 2-year compliance period. However,
FDA is concerned that the lead times necessary to manufacture limited
powder gloves would make compliance difficult. As stated earlier,
manufacturing equipment used to control glove powder levels is
currently backordered as much as 18 months, and short compliance
periods may result in inadequate supplies of medical gloves. Not
including the potential of shortages, FDA has estimated that average
annualized costs of shorter compliance periods could equal $10 million
to $16 million more than the selected alternative. The 2-year
compliance period allows firms to combine recommended changes with any
other market driven changes, and will allow firms to deplete their
supply of existing labels. As set forth above, however, FDA is
soliciting comment on the timeframe for implementation to determine
whether a 2-year compliance period is really needed. FDA also rejected
providing a longer compliance period. FDA has tentatively determined
that the decrease in costs is outweighed by the decrease in benefits if
the compliance period is lengthened to as many as 3 years. While annual
costs would decrease by almost $9 million, allowing such a long
compliance period would result in about 1,800 additional average annual
allergic reactions as compared to the selected alternative and benefits
would be reduced to $32.0 million. Since glove manufacturers would have
ample opportunity to comply within the
[[Page 41740]]
selected 2-year period, FDA does not believe that additional time is
justified.
FDA solicits comments on other alternatives that meet the stated
objectives.
4. Assuring Small Entity Participation in Rulemaking
At this time, FDA does not believe that the proposed regulation
will have a significant economic impact on a substantial number of
small entities. However, the agency recognizes that many facilities
will be affected. The impact may range from increased glove
manufacturing costs due to validation testing and control of mold
powder to increased contract prices of powdered gloves used by health
facilities. FDA solicits comments from affected entities to ensure that
this impact is analyzed.
FDA plans to provide for access to the Federal Register analysis
through FDA's website on the Internet. Notice of the availability of
this proposed rule and request for comment will be communicated to all
glove-related associations and include a request for comments.
FDA is currently preparing an article for publication in latex-
related trade publications that will highlight the proposed
requirements. In addition, notice of the proposed rulemaking and
request for comments will be available in health-related publications
and sent to trade organizations. FDA actively seeks input into this
proposal and requests comments on all aspects of the analysis of
impacts and the regulatory flexibility analysis.
X. Conclusion
FDA has examined the impacts of the proposed regulation of protein
and powder levels of NL gloves. Based on these estimates, the average
annual quantifiable benefits ($46.9 million) exceed the average annual
quantifiable costs ($32.5 million). Given the high level of uncertainty
and the existence of unquantified benefits, FDA solicits comment on
this analysis and all of its assumptions and projections.
XI. Environmental Impact
FDA has determined under 21 CFR 25.30(k) and 25.34(b) that this
action is of the type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
XII. Paperwork Reduction Act of 1995
This proposed rule contains information collections provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). A
description of these provisions is given below with an estimate of the
annual reporting burden. Included in the estimate is the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing each
collection of information.
FDA invites comments on: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Title: Labeling and Written Procedures Requirements for Powdered
and Powder-Free Patient Examination Gloves, and Powdered and Powder-
Free Surgeon's Gloves.
Description: The proposed rule intends to provide users with
material information to safely use patient examination and surgeon's
gloves. The proposed rule expands the labeling for medical gloves to
include: (1) Caution statements including the actual levels of protein
and powder on the gloves, and (2) expiration dating.
The proposed labeling requirements would require manufacturers to
conduct tests to support the protein and glove powder levels and
expiration date. The proposed special control, a guidance document
entitled ``Medical Glove Guidance Manual,'' recommends that protein
levels be measured by the ASTM D 5712 modified Lorry method and that
glove powder levels be measured by the ASTM D6124-97 method. The
labeling requirements also require stability testing to support the
expiration date. The special control recommends that stability testing
include tensile strength, elongation and water leak tests.
The labeling is intended to communicate useful information to users
about FDA's guidance recommending the use of gloves with no more than
1,200 g of protein and 120 mg of glove powder (or 2 mg of
powder, for powder-free gloves) and to ensure that the labeling
contains adequate directions for use. The labeling would require
manufacturers to indicate the actual levels of protein and powder on
the gloves so that the user can ascertain if the gloves meet the
recommended limits on protein and powder, which are intended to reduce
exposure to particulates and airborne allergens. The expiration date
labeling is intended to ensure that medical glove users have
appropriate information regarding shelf life to enable them to use
medical gloves safely by avoiding products that may have degraded.
Description of Respondents: Businesses or other for profit
organizations.
Table 12.--Estimated Annual Reporting Burden1
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours Total Capital
Respondents Response Responses Response Costs
----------------------------------------------------------------------------------------------------------------
801.440(a) 180 1 180 22 3,960 $985,248
801.440(b) 18 1 18 14 252
801.440(c) 178 1 178 16 2,848
801.440(d) 376 42 1,504 72 108,288
Total 115,348 $985,248
----------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.
\2\ The annual burden reported here represents the first year in which a manufacturer would have conducted
testing at 0 days, 3 months, 6 months, and 1 year. FDA expects in any succeeding years, testing would only be
done at 6-month intervals.
[[Page 41741]]
For the proposed labeling requirements, the hours per response
included the hours estimated, based upon communications with industry,
to run the tests to support the powder and protein levels and the
expiration date, as well as the hours estimated to change the
respondent's labeling. The total capital costs were derived from
multiplying the total annual responses for protein testing and
multiplying it by the estimated costs of buying a spectrometer and a
plate reader, instruments that are necessary to conduct the protein
testing. That cost was then annualized over a 5-year period.
Based on communication with industry, FDA estimates that a
respondent would take approximately 8 hours to run the protein tests
necessary to obtain a protein level to add to the labeling. FDA bases
its estimate on the ASTM D 6124-97 protein test.
Based on communication with industry, FDA estimates that a
respondent would take approximately 6 hours to run the powder tests
necessary to obtain a powder level to add to the labeling. FDA bases
its estimate on the ASTM D 5712 modified Lowry method powder test.
Based on communication with industry, FDA estimates that a
respondent would take approximately 16 hours to run the elongation,
tensile strength, and waterleak tests recommended to support the
expiration date. In the first year, FDA estimates that the tests would
be run 4 times, at 0 days, 3 months, 6 months, and 1 year (16 X 4 =
64). In the second, or succeeding years, FDA expects the tests to be
run twice a year.
FDA estimates that a respondent would take approximately 8 hours to
change the labeling and approximately 8 hours to change the promotional
materials to include the appropriate caution statement and the
expiration date. This 16 hours is divided between the labeling changes
proposed in Sec. 801.440(a) and (d) resulting in 8 hours being assessed
for the caution statement and 8 hours being assessed for the expiration
date.
FDA estimates the number of burden hours per response for
Sec. 801.440(a) is 22. That burden comes from the sum of the hours for
running the powder and protein tests (8 hours plus 6 hours) and the
hours for changing the labeling (8 hours).
FDA estimates the number of burden hours per response for
Sec. 801.440(b) is 14. That burden comes from the sum of the hours for
running the powder tests (6 hours) and the hours for changing the
labeling (8 hours).
FDA estimates the number of burden hours per response for
Sec. 801.440(c) is 16. That burden comes from the sum of the hours for
running the protein tests (8 hours) and the hours for changing the
labeling (8 hours).
FDA estimates the number of burden hours per response for
Sec. 801.440(d) is 72. That burden comes from the sum of the hours for
running the elongation, tensile strength, and waterleak tests four
times in the first year (64 hours) and the hours for changing the
labeling (8 hours).
FDA believes that manufacturers already have the equipment
necessary to do the tests to support the powder levels and expiration
dating because such equipment is currently being used to test the
gloves. In order to do the protein tests recommended by FDA, FDA
believes a manufacturer would need to obtain a spectrometer and a plate
reader. FDA estimates that buying this equipment would cost
approximately $22,000 (approximately $10,000 for the spectrometer and
$12,000 for the plate reader). In addition, FDA assumed a 7 percent
discount on the price of the equipment and that the equipment would be
annualized over a 5-year period. In order to obtain a per annualized
year estimate, FDA multiplied the cost by the discount ($22,000 x
.244). FDA added the discounted amount ($5,368) to the cost of the
equipment ($22,000) for a total equipment cost of $27,368. That cost
annualized over a 5-year period is $5,473.60. FDA multiplied that cost
by the number of respondents testing for protein levels (180) for a
total capital cost of $985,248.
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3507(d)), FDA has submitted the information collection provisions of
this proposed rule to OMB for review. Interested persons are requested
to send comments regarding information collection by August 30, 1999,
to the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn.:
Wendy Taylor, Desk Officer for FDA.
XIII. References
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Kaczmarek, R., R. Moore, J. McCrohan, et al., ``Glove Use by
Health Care Workers: Results of a Tri-state Investigation,''
American Journal of Infection Control, 19:228-232, 1991.
2. Kibby, T., and M. Akl, ``Prevalence of Latex Sensitization in
a Hospital Employee Population,'' Annals of Allergy, Asthma &
Immunology, 78:41-44, 1997.
3. Kaczmarek, R., B. Silverman, T. Gross, et al., ``Prevalence
of Latex-specific IgE Antibodies in Hospital Personnel,'' Annals of
Allergy, Asthma & Immunology, 76:51-56, 1996.
4. Arellano, R., J. Bradley, and G. Sussman, `` Prevalence of
Latex Sensitization Among Hospital Physicians Occupationally Exposed
to Latex Gloves,'' Anesthesiology, 77:905-908, 1992.
5. Lagier, F., D. Vervioet, I. Lhermet, et al., `` Prevalence of
Latex Allergy in Operating Room Nurses,'' Journal of Allergy and
Clinical Immunology, 90:319-322, 1992.
6. Yassin, M., M. Lierl, T. Fischer, et al., ``Latex Allergy in
Hospital Employees,'' Annals of Allergy, 72:245-249, 1994.
7. Ownby, D., H. Ownby, J. McCullough, and A. Shafer, ``The
Prevalence of Anti-latex IgE Antibodies in 1000 Volunteer Blood
Donors [Abstract],'' Journal of Allergy and Clinical Immunology,
97:1188-1192, 1996.
8. Lebenbom-Mansour, M., J. Oesterle, et al., ``The Incidence of
Latex Sensitivity in Ambulatory Surgical Patients: A Correlation of
Historical Factors with Positive Serum Immunoglobin E Levels,''
Anesthesia and Analgesia, 85:44-49, July 1997.
9. FDA, Medical device reporting databases of adverse event
reports, Rockville, MD, 1996-1997 (World Wide Web access: http://
www.fda.gov/cdrh/mdr.html).
10. Beezhold, D. and W. Beck, ``Surgical Glove Powders Bind
Latex Antigens,'' Archives of Surgery, 127:1354-1357, 1992.
11. Tomazic, V., E. Shampaine, A. Lamanna, T. Withrow, N.
Adkinson, Jr., and R. Hamilton, ``Cornstarch Powder on Latex
Products Is an Allergen Carrier,'' Journal of Allergy and Clinical
Immunology, 93:751-758, 1994.
12. Tarlo, S., G. Sussman, A. Contala, and M. Swanson, ``Control
of Airborne Latex by Use of Powder-free Latex Gloves,'' Journal of
Allergy and Clinical Immunology, 93:985-989, 1994.
13. Swanson, M., M. Bubak, L. Hunt, J. Yunginger, M. Warner, and
C. Reed, ``Clinical Aspects of Allergic Disease: Quantification of
Occupational Latex Aeroallergens in a Medical Center,'' Journal of
Allergy and Clinical Immunology, 94:445-451, 1994.
14. Heilman, D., R. Jones, M. Swanson, and J. Yunginger, ``A
Prospective, Controlled Study Showing that Rubber Gloves Are the
Major Contributor to Latex Aeroallergen Levels in the Operating
Room,'' Journal of Allergy and Clinical Immunology, 98:325-330,
1996.
15. Ellis, H., ``The Hazards of Surgical Glove Dusting
Powders,'' Surgery, Gynecology & Obstetrics, 171: 521-527, 1990.
16. Edlich, R., ``A Plea for Powder-free Surgical Gloves,'' The
Journal of Emergency Medicine, 12:69-71, 1994.
17. Hunt, T., J. Slavin, and W. Goodson, ``Starch Powder
Contamination of Surgical Wounds,'' Archives of Surgery, 129: 825-
828, 1994.
18. Luijendijk, R., D. deLange, C. Wauters, W. Hop, et al.,
``Foreign Material in Postoperative Adhesions,'' Annals of Surgery,
223: 242-248, 1996.
[[Page 41742]]
19. Holmdahl, L., B. Risberg, D. Beck, et al., ``Adhesions:
Pathogenesis and Prevention-Panel Discussion and Summary,'' European
Journal of Surgery, Supplement, 163 (Suppl. 577), 56-62, 1997.
20. Williams, P., and J. Halsey, ``Endotoxin as a Factor in
Adverse Reactions to Latex Gloves,'' Annals of Allergy, Asthma, and
Immunology, 79:303-310, October 1997.
21. Department of Health and Human Services (NIOSH), ``National
Institute of Occupational Safety and Health (NIOSH) Alert:
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List of Subjects
21 CFR Part 801
Labeling, Medical devices, Reporting and recordkeeping
requirements.
21 CFR Parts 878 and 880
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR parts 801, 878, and 880 be amended as follows:
PART 801--LABELING
1. The authority citation for 21 CFR part 801 is revised to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 360c, 360i, 360j, 371,
374.
2. Section 801.437 is amended by revising paragraph (d) to read as
follows:
Sec. 801.437 User labeling for devices that contain natural rubber.
* * * * *
(d)(1) As described in paragraph (b) of this section, devices
containing natural rubber latex that contacts humans, except natural
rubber latex surgeon's and patient examination gloves shall bear the
following statement in bold print on the device labeling:
``Caution: This Product Contains Natural Rubber Latex Which May
Cause Allergic Reactions.''
This statement shall appear on all device labels, and other labeling,
and shall appear on the principal display panel of the device
packaging, the outside package, container, or wrapper, and the
immediate device package, container, or wrapper.
(2) Natural rubber latex surgeon's and patient examination gloves
shall bear the appropriate caution statement delineated in
Sec. 801.440(a) or (c). This statement shall appear on all device
labels, and other labeling, and shall appear on the principal display
panel of the device packaging, the outside package, container, or
wrapper, and the immediate device package, container, or wrapper.
* * * * *
3. Section 801.440 is added to subpart H to read as follows:
[[Page 41743]]
Sec. 801.440 User labeling for powdered and powder-free surgeon's and
patient examination gloves.
The caution statements required in this section shall appear on all
device labels, and other labeling, and shall appear on the principal
display panel of the device packaging, the outside package, container,
or wrapper, and the immediate device package, container, or wrapper.
(a) Natural rubber latex powdered surgeon's gloves and powdered
patient examination gloves shall bear the following statement:
``Caution: This product contains natural rubber latex which may cause
allergic reactions. FDA recommends that this product contain no more
than 120 mg powder and 1,200 g extractable protein per glove.
This product contains no more than [insert level] mg powder and no more
than [insert level] g extractable protein per glove.''
(b) Synthetic material powdered surgeon's or powdered patient
examination gloves shall bear the following statement: ``Caution: Glove
powder is associated with adverse reactions. FDA recommends that this
product contain no more than 120 milligrams powder per glove. This
product contains no more than [insert level] mg powder per glove.''
(c) Natural rubber latex powder-free surgeon's gloves and powder-
free patient examination gloves shall bear the following statement:
``Caution: This product contains natural rubber latex which may cause
allergic reactions. FDA recommends that this product contain no more
than 1,200 g extractable protein per glove. This product
contains no more than [insert level] g extractable protein per
glove.''
(d) All surgeon's and patient examination gloves shall bear an
expiration date as follows:
(1) The expiration date shall state the month and year of the
shelf-life as supported by data from the studies described in paragraph
(d)(3) of this section;
(2) The expiration date must be prominently displayed on the
exterior of the primary and retail package, and on the shipping carton;
(3) The expiration date must be supported by stability studies
demonstrating acceptable physical and mechanical integrity of the
product over the shelf-life of the product from its date of
manufacture;
(4) For each glove design, the testing data and stability study
protocol supporting an expiration date must be maintained by the
manufacturer for a period equivalent to the design and expected life of
that glove type, and shall be made available for inspection and copying
by FDA; and
(5) Sterile surgeon's and patient examination gloves that have a
date of expiration based on sterility that is different from the
expiration date based upon physical and mechanical integrity testing
shall bear only the earlier expiration date.
PART 878--GENERAL AND PLASTIC SURGERY DEVICES
4. The authority citation for 21 CFR part 878 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
5. Section 878.4460 is revised to read as follows:
Sec. 878.4460 Surgeon's gloves, powdered.
(a) Identification. A powdered surgeon's glove is a disposable
device made of natural rubber latex or synthetic material that bears
powder to facilitate donning, and it is intended to be worn on the
hands, usually in surgical settings, to provide a barrier against
potentially infectious materials and other contaminants. The
lubricating or dusting powder used on these gloves is classified
separately in Sec. 878.4480.
(b) Classification. Class II special controls are as follows:
(1) Guidance document. The Center for Devices and Radiological
Health, FDA, ``Medical Glove Guidance Manual,'' as revised. The
guidance document is available from the Division of Small Manufacturers
Assistance (HFZ-220), Center for Devices and Radiological Health, Food
and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850.
(2) Labeling. User labeling requirements in Sec. 801.440 of this
chapter.
6. Section 878.4461 is added to subpart E to read as follows:
Sec. 878.4461 Surgeon's gloves, powder-free.
(a) Identification. A powder-free surgeon's glove is a disposable
device made of natural rubber latex or synthetic material that may bear
a trace amount of glove powder and is intended to be worn on the hands,
usually in surgical settings, to provide a barrier against potentially
infectious materials and other contaminants.
(b) Classification. Class II special controls are as follows:
(1) Guidance document. The Center for Devices and Radiological
Health, FDA, ``Medical Glove Guidance Manual,'' as revised (See
Sec. 878.4460(b)(1)).
(2) Labeling. User labeling requirements in Sec. 801.440 of this
chapter.
PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES
7. The authority citation for 21 CFR part 880 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
8. Section 880.6250 is revised to read as follows:
Sec. 880.6250 Patient examination gloves, powdered.
(a) Identification. A powdered patient examination glove is a
disposable device made of natural rubber latex or synthetic material
that bears powder to facilitate donning and is intended to be worn on
the hand or finger(s) for medical purposes to provide a barrier against
potentially infectious materials and other contaminants.
(b) Classification. Class II special controls are as follows:
(1) Guidance document. The Center for Devices and Radiological
Health, FDA, ``Medical Glove Guidance Manual,'' as revised. The
guidance document is available from the Division of Small Manufacturers
Assistance (HFZ-220), Center for Devices and Radiological Health, Food
and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850.
(2) Labeling. User labeling requirements in Sec. 801.440 of this
chapter.
9. Section 880.6251 is added to subpart G to read as follows:
Sec. 880.6251 Patient examination gloves, powder-free.
(a) Identification. A powder-free patient examination glove is a
disposable device made of natural rubber latex or synthetic material
that may bear a trace amount of glove powder and is intended to be worn
on the hand or finger(s) for medical purposes to provide a barrier
against potentially infectious materials and other contaminants.
(b) Classification. Class II special controls are as follows:
(1) Guidance document. The Center for Devices and Radiological
Health, FDA, ``Medical Glove Guidance Manual,'' as revised (See
Sec. 880.6250(b)(1)).
(2) Labeling. User labeling requirements in Sec. 801.440 of this
chapter.
Dated: March 2, 1999.
Jane E. Henney,
Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 99-19191 Filed 7-29-99; 8:45 am]
BILLING CODE 4160-01-F
