[Federal Register Volume 60, Number 181 (Tuesday, September 19, 1995)]
[Rules and Regulations]
[Pages 48374-48387]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23130]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1000 and 1002

[Docket No. 82N-0273]
RIN 0905-AD78


Records and Reports Regulations for Radiation Emitting Electronic 
Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations regarding the requirements for recordkeeping and reporting 
of adverse experiences and other information relating to radiation 
emitting electronic products. This rule reduces recordkeeping and 
reporting requirements for some products, requires only abbreviated 
reporting for other products, and clarifies certain requirements. The 
timing and content of certain reports will be revised to enhance the 
usefulness of the information. These amendments will improve protection 
of the public health while reducing regulatory burdens on 
manufacturers, dealers, and distributors of radiation emitting 
electronic products.

EFFECTIVE DATE: October 19, 1995.

FOR FURTHER INFORMATION CONTACT: Joanne Barron, Center for Devices and 
Radiological Health (HFZ-300), Food and Drug Administration, 2094 
Gaither Rd., Rockville, MD 20850, 301-594-4654.

SUPPLEMENTARY INFORMATION:

I. Background

    The Regulatory Flexibility Act (5 U.S.C. 601) and Executive Order 
12866 require FDA to periodically conduct a comprehensive review of 
existing regulations. This review is to analyze alternative regulatory 
approaches and to identify regulations that need to be revised or 
revoked because they impose an unnecessary burden on specific segments 
of the public, such as manufacturers, dealers, small businesses, or the 
general public. In the Federal Register of July 2, 1982 (47 FR 29004), 
FDA announced its plan to review the records and reports regulations in 
part 1002 (21 CFR part 1002). FDA recognized that, although part 1002 
does not appear to have a major impact on the overall radiation 
emitting electronic products industry, its impact on small 
manufacturers 

[[Page 48375]]
should not be overly burdensome and should be determined.
    FDA recognizes that, for some products, meeting the full 
recordkeeping and reporting requirements is not necessary to protect 
the public health. Therefore, in the final rule, FDA has reduced the 
recordkeeping and reporting requirements for some products and 
determined that an abbreviated report is sufficient regulatory 
monitoring for other products. FDA also recognizes that some sections 
of the regulations need additional clarification to be more meaningful 
and reduce regulatory burdens. Thus, FDA has adopted certain amendments 
to clarify its regulations.
    On October 25, 1990, FDA published in the Federal Register (55 FR 
43066) a proposed rule amending its regulations regarding the 
requirements for recordkeeping, reporting, and other information 
relating to radiation emitting electronic products. FDA invited 
interested parties to comment on the proposed rule by January 22, 1991. 
The comment period was later extended until March 25, 1991 (56 FR 
7316). FDA received 11 comments. A summary of these comments and FDA's 
responses to them are set forth below. FDA is finalizing the proposed 
rule at this time and incorporating changes that are the result of the 
agency's review of the comments.
    FDA is also amending references to statutory citations to reflect 
changes in the law. On November 28, 1990, the President signed into law 
the Safe Medical Devices Act of 1990 (the SMDA), which amended the 
Federal Food, Drug, and Cosmetic Act (the act). Section 19 of the SMDA 
transferred the Radiation Control for Health and Safety Act of 1968 
from the Public Health Service Act (the PHS Act) into the act as 
subchapter C. Thus, all references to the PHS Act in parts 1000 and 
1002 (21 CFR parts 1000 and 1002) are being revised to reflect this 
change. Additionally, the agency is changing all references to the 
``Office of Compliance and Surveillance'' throughout parts 1000 and 
1002 to the ``Office of Compliance'' to reflect an organizational 
change within the Center for Devices and Radiological Health (CDRH). 
The agency is also changing references to ``the Secretary'' and to 
``the Director'' of CDRH in order to reflect the delegation of the 
Secretary's authority in accordance with 21 CFR 5.90.

II. Highlights of the Final Rule

    To reduce the regulatory burden on the industry, FDA is amending 
regulations regarding the recordkeeping and reporting requirements for 
certain radiation emitting electronic products.
    First, the reporting requirements in Sec. 1002.12 (reports of model 
changes) have been consolidated with the requirements of Sec. 1002.10 
(initial reports), and the name ``initial report'' has been changed to 
``product report.''
    Second, FDA has developed two new categories of reports, 
``supplemental reports'' in Sec. 1002.11, and ``abbreviated reports'' 
in Sec. 1002.12. New Sec. 1002.11 (supplemental reports), which 
requires manufacturers to provide information on product safety and 
testing, applies to a smaller subset of manufacturers, and reduces the 
number of required reports by approximately 40 percent. New 
Sec. 1002.12 (abbreviated reports) requires manufacturers to report 
abbreviated information on product safety and testing and replaces the 
existing requirements for many initial reports and model change 
reports. Although the total combined number of product reports and 
abbreviated reports will remain about the same as the former initial 
reports and model change reports, the time necessary to complete the 
reports will be reduced by approximately 60 percent.
    Finally, FDA has limited the applicability of the records 
requirements in Secs. 1002.30 and 1002.40. These changes have reduced 
the number of records to be maintained by manufacturers and by dealers/
distributors by 50 percent and 99 percent, respectively.
    Overall, this final rule will reduce the annual reporting and 
recordkeeping burden hours on the industry by 81 percent, without 
reducing public health protection.

III. Comments

    The following is a summary of the comments and the agency's 
responses to them.

A. Reporting Requirements

    1. One comment stated that there are no relevant changes in the 
content or format of the initial report to warrant a name change to 
``product report.'' The comment states that the name change would 
result in unnecessary additional costs because personnel, particularly 
nonregulatory staff, who are familiar with the term initial report, 
would need to be reeducated.
    FDA recognizes that, as with any new requirement, the affected 
parties may need some training in order to appreciate and understand 
the changes. In this case, the change is intended to lessen the burden 
of this requirement by clearly describing the reports that are 
required, and the filing and content requirements of such reports. For 
example, FDA has deleted the reference to a 90-day due date for filing 
an initial report (see revised Sec. 1002.10) because that requirement 
was applicable only to newly listed products. FDA believes that the 
long-term benefits of such changes--clearer regulatory requirements, a 
reduced regulatory burden on industry, and improved cost effectiveness 
and efficiency--outweigh its short-term training costs. Because FDA and 
the industry have used the previous term for 20 years, it is expected 
that there will be a period of transition to the new term over the next 
year for both the industry and FDA personnel.
    2. One comment stated that industrial x-ray systems should not be 
included in the list of products for which abbreviated reports, rather 
than initial reports (to be called ``product reports''), are required. 
The comment expressed the belief that industrial x-ray systems should 
follow the same reporting requirements as diagnostic x-ray and other x-
ray systems.
    FDA included analytical and industrial x-ray equipment in the list 
of products for which abbreviated reports are required because there is 
no FDA radiation performance standard for these products and, unlike 
diagnostic x-ray systems, any exposure of people to radiation would be 
unintentional. In addition, the users of such equipment are trained to 
be more aware of precautions necessary to reduce or eliminate 
exposures. In the event that a public health concern arises, however, 
the regulation would permit FDA to request additional safety 
information from the manufacturer.
    3. One comment asked whether FDA will exempt linear accelerators 
and low-energy therapy x-ray devices from annual reporting 
requirements.
    Linear accelerators and low-energy therapy x-ray equipment are 
included in Sec. 1002.1, Table 1, under the category of ``Products 
Intended to Produce Particulate Radiation or X-rays Other Than 
Diagnostic or Cabinet X-ray.'' The format of Table 1 has been modified 
to make clear that the requirements are the same for all medical, 
analytical, and industrial systems that fall within this product 
category. Specifically, manufacturers are required to submit 
abbreviated and annual reports and to maintain test and distribution 
records for these products.
    4. One comment expressed the concern that, unlike television 
receivers, video display terminals (VDT's) are not specifically 
delineated by FDA under the reporting and recordkeeping provisions of 
the regulations. The comment stated that there is little 

[[Page 48376]]
difference between television receivers and VDT screens and monitors 
and, therefore, these products should be treated similarly in these 
provisions. The comment stated that recent investigations of VDT use 
have shown that low levels of electromagnetic radiation are emitted 
from certain brands and models. The comment stated that the health and 
safety effects of these emissions are unknown, but the nature of most 
VDT work suggests that the effects may be detrimental. Given the health 
concerns, and the fact that such emissions have generally not been 
examined, the comment recommended that manufacturers be required to 
provide product reports, supplemental reports, annual reports, and test 
records to VDT purchasers, who in turn should be required to relay such 
information to their employees and representatives. The comment 
suggested that the hazard communication standard under the Occupational 
Safety and Health Act (29 CFR 1910.1200) would provide a model for FDA 
in constructing radiation recordkeeping requirements for VDT's.
    FDA has used the designation ``television products'' in 
Sec. 1002.1, Table 1, to reflect the scope of the product category that 
is the subject of the performance standard for television receivers at 
21 CFR 1020.10. The intent of that standard has been to reduce 
unnecessary x-ray exposure to persons from any electronic product that 
can display a viewable picture on a cathode ray tube (CRT). FDA agrees 
that there are a number of clarifications that need to be made 
regarding this category of products. FDA anticipates issuing a notice 
of proposed rulemaking to amend the television receiver standard to 
address the issues raised in this comment and other issues concerning 
VDT's. FDA will propose the appropriate changes to part 1002 when the 
performance standard for television receivers is amended.
    With respect to the suggestion that manufacturers be required to 
provide reports and records to users of VDT's, amended Sec. 1002.3 will 
provide the mechanism for FDA to require manufacturers to provide the 
ultimate purchaser of the product with necessary performance and 
technical data.
    5. One comment stated that a 25 kilovolt (kV) criterion should be 
established for television receivers to differentiate between 
television receivers that will be subject to relatively moderate 
reporting requirements (abbreviated reports and annual reports) and 
those that will be subject to more substantial reporting requirements 
(product reports, supplemental reports, and annual reports).
    FDA agrees with this comment and adopted a 25 kV criterion in the 
rule. See Sec. 1002.1, Table 1.
    6. One comment stated that television receivers with less than 25 
kV and less than 0.1 milliroentgen per hour (mR/hr) should be relieved 
of the annual report requirement of 1002.13 and the preservation and 
inspection of records provisions of Sec. 1002.31. The comment asserted 
that exemptions from these provisions already apply to receivers with 
less than 25 kV pursuant to a 1987 letter to industry which stated that 
only status identification is required for annual reports on these 
products.
    Consistent with the November 16, 1987, letter to manufacturers of 
television receiver products from the Director of CDRH (Ref. 1), 
television receivers which, when tested under phase III conditions, 
will not equal or exceed 25 kV and for which the chassis power curve 
will not reach or exceed the 0.1 mR/hr isoexposure rate limit curve 
(IRLC) are relieved of the annual report requirement of Sec. 1002.13 
and the preservation and inspection of records provisions of 
Sec. 1002.31. Section 1002.1, Table 1, has been revised accordingly.-
    7. One comment noted discrepancies between the preamble language 
and Table 1 of the proposed rule. The preamble states that abbreviated 
reports will replace initial and supplemental reports for ``certain 
television products.'' The text further states that product reports, 
but not supplemental reports, will be required for television receivers 
emitting less than 0.1 mR/hr. However, Table 1 of the proposed rule 
states that television receivers with less than 25 kV and less than 0.1 
mR/hr will require abbreviated reports and television receivers 
emitting greater than 0.1 mR/hr will require only product reports (not 
supplemental reports). The comment supports the requirements as set 
forth in Table 1, but recommends, consistent with the preamble, that 
the requirement for supplemental reports be deleted for television 
receivers with greater than 25 kV and less than 0.1 mR/hr.
    FDA has corrected the errors appearing in Table 1. Since November 
16, 1987, the policy at CDRH has been that certain categories of 
television products may be exempt from some of the reporting and 
recordkeeping requirements, depending on the maximum high voltage on 
the picture tube and the possibility of emission of x-rays at or above 
0.1 mR/hr. Manufacturers were given the responsibility to conduct phase 
III tests and inform CDRH, through annual reports, which models qualify 
for such exemptions. The agency's intention was to maintain the same 
level of requirements under the amended reporting and recordkeeping 
regulations that has previously been in effect for products that may 
operate at or above 25 kV and products that may emit x-rays at a rate 
of 0.1 mR/hr or above. The agency believes that these products 
represent different levels of risks and that different levels of 
recordkeeping and reporting requirements continue to be appropriate for 
each category.
    Therefore, any television product that contains a CRT or other 
component capable of producing x-rays, and which, when tested under 
phase III conditions, will not equal or exceed 25 kV and for which the 
chassis power curve will not reach or exceed the 0.1 mR/hr IRLC, will 
require only abbreviated reports. A television product containing a 
CRT, which, when tested under phase III conditions, may equal or exceed 
25 kV but for which the chassis power curve does not reach or exceed 
the 0.1 mR/hr IRLC, will require product reports, supplemental reports, 
and annual reports. A television product containing a CRT, for which, 
when tested under phase III conditions, the chassis power curve reaches 
or exceeds the 0.1 mR/hr IRLC, will require product reports, 
supplemental reports, annual reports, and maintenance of the records of 
test results and distribution of products for 5 years.
    Manufacturers must continue to conduct an adequate quality control 
and testing program to ensure continued compliance of all models with 
the performance standard. Products for which there is no requirement 
that test results be kept for 5 years must, nevertheless, be tested 
adequately and the results should be reviewed by a quality control 
manager. These products should be rejected at a maximum limit of 0.1 
mR/hr when tested under phase III conditions.
    The agency retains the authority to inspect all documents 
supporting the adequacy of the manufacturer's quality control and 
testing program, including programs for these products for which it is 
not necessary to retain test results for 5 years. The final rule has 
added a footnote to Table 1 (footnote 1) to clarify this point.
    8. One comment stated that FDA should codify its existing practice 
concerning importation of products for compliance testing and other 
related purposes to reduce the potential for confusion about the 
precise terms and conditions surrounding these activities. The comment 
stated that bulletins sent by FDA to the industry have stated, at 

[[Page 48377]]
least with respect to television receivers and laser products, that FDA 
performance standards do not apply to products ``that are imported for 
purpose of research, investigations, studies, demonstrations, or 
training, and that consist of 10 or fewer units per shipment,'' so long 
as certain administrative safeguards are observed.
    The scope of this rule is limited to the reporting andrecordkeeping 
requirements in part 1002 and is not intended to amend FDA practices 
and regulations regarding the scope of the applicability of performance 
standards. Under current policies, FDA allows exemptions from 
performance standards for 10 or fewer units of certain products (i.e., 
television products, microwave ovens, and certain laser products), that 
are imported for test and evaluation and remain under the importer's 
control, if such products are properly labeled. These exemptions are 
referenced in FDA Compliance Program 7382.007 which is available from 
the Division of Small Manufacturers Assistance, Center for Devices and 
Radiological Health (HFZ-220), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 800-638-2041 or 301-443-6597. These 
policies will be continued but this rule does not expand the scope of 
that exemption to all products. However, the rule codifies procedures 
that allow manufacturers to apply for special exemptions from the 
reporting and recordkeeping requirements of part 1002 or the Director 
of CDRH to grant such exemptions on his or her own. See 
Secs. 1002.50(a)(3) and 1002.50(b).
    9. One comment requested that FDA clarify the distinctionbetween 
television receivers and CRT's and explain whether there are 
differences in the regulations that apply to the products that fall 
within these two categories. The comment noted that the majority of 
television receivers use CRT's to display video images (a small 
minority of receivers use liquid crystal displays), and the comment was 
uncertain why television receivers remain subject to various reporting 
requirements while CRT's will be generally exempt from reporting 
requirements, with the exception of Sec. 1002.20. The comment further 
stated that FDA's distinction apparently depends on whether a device is 
limited by design to display only alphanumeric characters (CRT) or 
whether it can also display other video images (television receiver). 
The comment stated that FDA's distinction does not appear to be based 
on public health considerations, and that confusion and potential 
compliance problems would be avoided by adopting a definition of 
television that is more consistent with that of the affected industry. 
The comment suggests that FDA consider adopting the definition used by 
the FCC, which defines television receiver as a ``device designed to 
receive television pictures that are broadcast simultaneously with 
sound on the television channels authorized under part 73 of the FCC's 
rules.'' (See 47 CFR 15.3(w)(1990)).
    Previously, the regulations required manufacturers to submit 
initial, model change, and annual reports for television receivers and 
to submit initial and model change reports for CRT's. A CRT is an 
electronic product component and, as such, is subject to the general 
radiation safety requirements, but not subject to a performance 
standard. FDA has determined that the Joint Electron Device Engineering 
Council/Tube Engineering Panel Advisory Council (JEDEC/TEPAC) data on 
CRT's that is available from the Electronic Industries Association is 
sufficient for FDA to assess the potential radiation hazards for CRT's; 
therefore, any additional reports on the CRT's are not necessary. 
However, the monitors and video display products that contain the CRT's 
and associated electronics are subject to the television receiver 
standard. Accordingly, manufacturers are required to demonstrate that 
these products, including the CRT's contained in them, meet the 
standard and to report how the products are tested for compliance. FDA 
currently is reviewing whether to change the performance standard for 
television receivers to clarify the definitions of products to which 
the standard is applicable. This comment will be included in that 
review.

B. Exemptions

    10. One comment proposed that manufacturers of products forwhich 
there is no applicable performance standard under 21 CFR part 1020 and 
for which a 510(k) premarket notification (510(k)) has been submitted 
and cleared in accordance with part 807, subpart E, be exempt from 
submitting all reports listed in Table 1 of proposed Sec. 1002.1. The 
comment believes it would be appropriate to include manufacturers of 
these products in the exemption under proposed Sec. 1002.50(e), because 
sufficient information regarding safety and effectiveness has been 
obtained through FDA review of the 510(k) submission. Alternatively, 
the comment suggests that the fact that any particular electronic 
product is also a medical device subject to 510(k) notifications should 
be included among the criteria for considering a special exemption 
under proposed Sec. 1002.50(a).
    Generally, a 510(k) notice on a medical device is submitted to FDA 
to demonstrate that a design specification is substantially equivalent 
to the specifications of a predicate device. The radiation safety 
reporting required by this part of the regulations is intended to 
provide information on actual production testing and quality control 
and on the actual product design as produced. If the two are redundant 
in any particular circumstance, the Director of CDRH can issue 
exemptions from the reporting and recordkeeping requirements in 
accordance with Sec. 1002.50(b). FDA does not believe a general 
exemption from the reporting requirement is in the interest of public 
health.-
    11. One comment objected to the exemption of distributors and 
dealers from the recordkeeping requirement for microwave ovens. The 
comment states that if such an exemption is granted, these products 
would be much more difficult to locate to ensure their safety. The 
comment notes that customer warranty registrations are not sufficient 
to locate products because such registrations are returned by the 
customers at such a low rate. The comment states that if the dealer/
distributor records are no longer required, the burden of locating the 
microwave oven shifts to the manufacturer who would have no other 
alternative but to launch an advertising campaign that would be more 
expensive, less effective, and slower than any recordkeeping on the 
part of distributors or dealers.
    It has been FDA's experience that dealer and distributor records 
are rarely needed for the intended purpose of notifying purchasers of 
product noncompliance. In light of the fact that there have been 
limited recalls of microwave ovens in the past 10 years (due in part to 
prototype examinations by FDA), FDA believes that it would be overly 
burdensome to require distributors and dealers to comply with the 
recordkeeping requirement. When recalls are necessary, FDA believes 
that purchasers can be notified by other means, such as general media 
announcements.
    12. One comment recommended that FDA exempt televisionreceivers 
whose voltage on the CRT is less than 5 kV at zero beam current from 
the recordkeeping and reporting requirements of part 1002, with the 
exception of Sec. 1002.20. The comment stated that there is no evidence 
to suggest that products with such a low voltage (generally, 
videocamera 

[[Page 48378]]
viewfinders and televisions with 2 or 3 inch screens) are capable of 
generating x-rays, which is the primary concern in part 1002. Another 
comment contended that it would be inappropriate to impose testing and 
reporting requirements on television receivers with less than 5 kV on 
the CRT, while CRT's with comparable or even greater voltages are 
exempted.
    Under the amended reporting and recordkeeping requirements, 
television products whose voltage on the CRT is less than 5 kV will 
require only abbreviated reports and annual reports, and manufacturers 
may apply for special exemption from these requirements under the new 
regulations in Sec. 1002.50. FDA will include these comments in the 
agency's review of possible amendments to the television performance 
standard.
    13. One comment noted that the preamble to the proposed rule states 
that television receivers emitting less than 0.1 mR/hr will be exempt 
from the requirements of maintaining manufacturer's testing and 
distribution records. The preamble also notes that other products, 
including ``television receivers,'' are already exempt from these 
requirements. In comparison, Table 1 of the proposed rule exempts all 
television receivers from the requirements to maintain manufacturer 
testing and distribution records. The comment supports the exemption 
for all television receivers as reflected in Table 1.
    A similar concern about the discrepancy between the preamble and 
Table 1 was addressed above in comment 7. There was an error in the 
printing of Table 1 of the proposed rule. For television receivers for 
which the chassis power curve reaches or exceeds the 0.1 mR/hr IRLC, 
there should have been an X in the following columns: Supplemental 
reports, Test records, and Manufacturer distribution records. These 
reports and records are important for FDA to monitor the safety of 
those products which, by design, can emit radiation levels above 
background. Table 1 has been amended accordingly.
    14. One comment noted an inadvertent error with respect 
tomanufacturer distribution recordkeeping requirements under 
Sec. 1002.30(b). The comment stated that FDA has eliminated these 
requirements for class I lasers and products containing such lasers. 
Proposed Table 1 to Sec. 1002.1, however, appears to state that class I 
lasers and products containing class I lasers will be subject to 
manufacturer distribution recordkeeping requirements under Sec.  
1002.30(b). The comment requested FDA to clarify, by amendment of 
proposed Table 1, that class I lasers and products containing such 
lasers will retain the exemptions that already apply, including the 
exemption for manufacturer's distribution records.
    Table 1 has been amended to clarify that the exemption for these 
products from certain reporting requirements remains in effect. FDA has 
added to Table 1 a category for ``Class I lasers and laser products 
containing such lasers,'' that will have X's in the columns for Product 
Reports, Annual Reports, Manufacturer's Test Records, but not for 
Supplemental Reports, Abbreviated Reports, Manufacturer's Distribution 
Records, or Dealer/Distributor Distribution Records.
    FDA will determine which reporting category is applicable to a 
product that may have more than one class of laser on the basis of the 
worst-case hazard in the product. Thus, a class I laser product 
containing a class IV laser and a class II alignment laser will fall in 
the category ``Class IIIb and IV lasers and products containing such 
lasers,'' because this represents the worst-case hazard within the 
product. Table 1 has been supplemented with a footnote to explain this 
policy (footnote 7).
    15. One set of comments supported the agency's efforts to minimize 
the reporting and recordkeeping requirements for radiation emitting 
electronic products. Another comment disagreed with the intent to 
eliminate initial reports for diagnostic ultrasound equipment. Instead, 
that comment proposed that diagnostic ultrasound equipment be added to 
the category of products for which an abbreviated report is required, 
and that such products be exempt from annual reports. The comment 
stated that this proposal would reduce the burden on the industry from 
the medical device premarket clearance process.
    Currently, diagnostic ultrasound devices are subject to initial 
reports but not annual reports. However, in a letter to all 
manufacturers of diagnostic ultrasound products from the CDRH Director 
dated February 24, 1986 (Ref. 2), these devices were exempted from the 
initial reports as long as a 510(k) was filed. CDRH issued this letter 
to reduce the burden and duplication of paperwork on the industry. The 
agency recognizes the increase in the timeframe necessary to gather all 
the information that must be submitted in the 510(k) notification, 
including production test information that otherwise would be contained 
in the initial report. Therefore, FDA has amended Table 1 to include 
abbreviated reports for diagnostic ultrasound equipment in order to 
retain its ability to obtain production test information about these 
products. However, CDRH intends to continue to exempt these products 
from the abbreviated (formerly initial) report requirement until 
documentation submitted for premarket clearance or for special controls 
is no longer duplicative of information that would be contained in the 
abbreviated report.

IV. Environmental Impact

    The agency has determined under 21 CFR 25.24(a)(8) that this action 
is of a 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.

V. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
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). The agency believes that 
this final rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the final 
rule is not a significant regulatory action as defined by the Executive 
Order and so is not subject to review under the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because the provisions of the final rule reduce or 
simplify the records and reporting requirements for manufacturers, 
dealers, and distributors of radiation emitting electronic products, 
the agency certifies that the final rule will not have a significant 
economic impact on a substantial number of small entities. Therefore, 
under the Regulatory Flexibility Act, no further analysis is required. 
A copy of the document supporting this determination, ``Report of the 
CDRH Task Force for Retrospective Review of the Recordkeeping and 
Reporting Requirements of 21 CFR 1002,'' is on file at the Dockets 
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857, and may be seen by interested 
persons in 

[[Page 48379]]
that office between 9 a.m. and 4 p.m., Monday through Friday.

VI. Paperwork Reduction Act of 1980

    This final rule contains information collections which are subject 
to review by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1980 (44 U.S.C. Chapter 35). The title, 
description, and respondent description of the information collection 
are shown below with an estimate of the annual reporting and 
recordkeeping 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 the 
collection of information.
    Title: Reporting and Recordkeeping Requirements for Electronic 
Products Under Pub. L. 90-602--General Requirements. -
    Description: The Food and Drug Administration is amending its 
regulations regarding the requirements for recordkeeping, reporting, 
and other information relating to radiation emitting electronic 
products. The timing and content of certain reports will be revised to 
enhance the usefulness of the information. The purpose of these changes 
is to improve the protection of the public health while also reducing 
the regulatory burden on manufacturers, dealers, and distributors of 
radiation emitting electronic products. -
    Description of Respondents: Businesses or other for profit 
organizations.

                                                                                                                
----------------------------------------------------------------------------------------------------------------
                               Estimated annual reporting and recordkeeping burden                              
-----------------------------------------------------------------------------------------------------------------
                                                Annual number of      Average burden per                        
                   Section                     reports and records     response (hours)    Annual burden (hours)
----------------------------------------------------------------------------------------------------------------
1002.10, 1002.12                              ....................  .....................  .....................
Existing:...................................                                                                    
Initial.....................................                320                    34                 10,880    
Model Change................................                725                    42                 30,450    
Supplements.................................              2,520                     0.5                1,260    
                                                                                                                
  Subtotal..................................              3,565                avg 11.9               42,590    
                                                                                                                
Amended:....................................                                                                    
Product.....................................                850                    24                 20,400    
Supplements.................................              1,500                     0.5                  750    
Abbreviated.................................                150                     5                    750    
                                                                                                                
  Subtotal..................................              2,500                 avg 8.8               21,900    
                                                                                                                
Total Reports Reduction.....................  ....................  .....................             20,690    
                                                                                                                
1002.30.....................................                                                                    
Existing:...................................          4,000,000                     0.12             480,000    
Amended:....................................          1,904,000                     0.12             480,000    
                                                                                                                
  Reduction:................................  ....................  .....................            251,520    
                                                                                                                
1002.40.....................................                                                                    
Existing:...................................         17,000,000                     0.048            816,000    
Amended:....................................            145,000                     0.048              6,960    
                                                                                                                
  Reduction:................................  ....................  .....................            809,040    
                                                                                                                
Total Records Reduction.....................  ....................  .....................          1,060,560    
                                                                                                                
Total existing annual burden hours..........  ....................  .....................          1,338,590    
Total amended annual burden hours...........  ....................  .....................            257,340    
Total difference in annual burden hours.....  ....................  .....................          1,081,250    
                                              ....................  .....................    (81% reduction)    
----------------------------------------------------------------------------------------------------------------

    As required by section 3504(h) of the Paperwork Reduction Act of 
1980, FDA has submitted a copy of this rule to OMB for its review of 
these information collection requirements. Other organizations and 
individuals desiring to submit comments regarding this burden estimate 
or any aspects of these information collection requirements, including 
suggestions for reducing the burden, should direct them to FDA's 
Dockets Management Branch (address above) and to the Office of 
Information and Regulatory Affairs, OMB, rm. 3208, New Executive Office 
Bldg., Washington, DC 20503, Attn: Desk Officer for FDA.

VII. 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. Director, CDRH, FDA, letter to manufacturers of television 
receiver products, dated November 16, 1987.
    2. Director, CDRH, FDA, letter to manufacturers of ultrasound 
products, dated February 24, 1986.

List of Subjects

21 CFR Part 1000

    Electronic products, Radiation protection, Reporting and 
recordkeeping requirements, X-rays.

[[Page 48380]]


21 CFR Part 1002

    Electronic products, Radiation protection, Reporting and 
recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act, the 
Radiation Control for Health and Safety Act, and under authority 
delegated to the Commissioner of Food and Drugs, 21 CFR parts 1000 and 
1002 are amended as follows:

PART 1000--GENERAL

    1. The authority citation for 21 CFR part 1000 is revised to read 
as follows:

    Authority: Secs. 530-542 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360hh-360ss).

    2. Section 1000.3 is revised to read as follows:


Sec. 1000.3  Definitions.

    As used in this Subchapter J:
    (a) Accidental radiation occurrence means a single event or series 
of events that has/have resulted in injurious or potentially injurious 
exposure of any person to electronic product radiation as a result of 
the manufacturing, testing, or use of an electronic product.
    (b) Act means the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360hh-360ss).
    (c) Chassis family means a group of one or more models with all of 
the following common characteristics:
    (1) The same circuitry in the high voltage, horizontal oscillator, 
and power supply sections;
    (2) The same worst component failures;
    (3) The same type of high voltage hold-down or safety circuits; and
    (4) The same design and installation.
    (d) Commerce means:-
    (1) Commerce between any place in any State and any place outside 
thereof, and
    (2) Commerce wholly within the District of Columbia.
    (e) Component, for the purposes of this part, means an essential 
functional part of a subassembly or of an assembled electronic product, 
and which may affect the quantity, quality, direction, or radiation 
emission of the finished product.
    (f) Dealer means a person engaged in the business of offering 
electronic products for sale to purchasers, without regard to whether 
such person is or has been primarily engaged in such business, and 
includes persons who offer such products for lease or as prizes or 
awards.
    (g) Director means the Director of the Center for Devices and 
Radioloical Health.
    (h) Distributor means a person engaged in the business of offering 
electronic products for sale to dealers, without regard to whether such 
person is or has been primarily or customarily engaged in such 
business.
    (i) Electromagnetic radiation includes the entire electromagnetic 
spectrum of radiation of any wavelength. The electromagnetic spectrum 
illustrated in Figure 1 includes, but is not limited to, gamma rays, x-
rays, ultra-violet, visible, infrared, microwave, radiowave, and low 
frequency radiation.


[[Page 48381]]
[GRAPHIC][TIFF OMITTED]TR19SE95.010


BILLING CODE 4160-01-C

[[Page 48382]]

    (j) Electronic product means:
    (1) Any manufactured or assembled product which, when in operation:
    (i) Contains or acts as part of an electronic circuit and
    (ii) Emits (or in the absence of effective shielding or other 
controls would emit) electronic product radiation, or -
    (2) Any manufactured or assembled article that is intended for use 
as a component, part, or accessory of a product described in paragraph 
(j)(1) of this section and which, when in operation, emits (or in the 
absence of effective shielding or other controls would emit) such 
radiation.
    (k) Electronic product radiation means:
    (1) Any ionizing or nonionizing electromagnetic or particulate 
radiation, or
    (2) Any sonic, infrasonic, or ultrasonic wave that is emitted from 
an electronic product as the result of the operation of an electronic 
circuit in such product.
    (l) Federal standard means a performance standard issued pursuant 
to section 534 of the Federal Food, Drug, and Cosmetic Act.
    (m) Infrasonic, sonic (or audible) and ultrasonic waves refer to 
energy transmitted as an alteration (pressure, particle displacement or 
density) in a property of an elastic medium (gas, liquid or solid) that 
can be detected by an instrument or listener.
    (n) Manufacturer means any person engaged in the business of 
manufacturing, assembling, or importing electronic products.
    (o) Model means any identifiable, unique electronic product design, 
and refers to products having the same structural and electrical design 
characteristics and to which the manufacturer has assigned a specific 
designation to differentiate between it and other products produced by 
that manufacturer.
    (p) Model family means products having similar design and radiation 
characteristics but different manufacturer model numbers.
    (q) Modified model means a product that is redesigned so that 
actual or potential radiation emission, the manner of compliance with a 
standard, or the manner of radiation safety testing is affected.
    (r) Particulate radiation is defined as:
    (1) Charged particles, such as protons, electrons, alpha particles, 
or heavy particles, which have sufficient kinetic energy to produce 
ionization or atomic or electron excitation by collision, electrical 
attractions or electrical repulsion; or
    (2) Uncharged particles, such as neutrons, which can initiate a 
nuclear transformation or liberate charged particles having sufficient 
kinetic energy to produce ionization or atomic or electron excitation.
    (s) Phototherapy product means any ultraviolet lamp, or product 
containing such lamp, that is intended for irradiation of any part of 
the living human body by light in the wavelength range of 200 to 400 
nanometers, in order to perform a therapeutic function.
    (t) Purchaser means the first person who, for value, or as an award 
or prize, acquires an electronic product for purposes other than 
resale, and includes a person who leases an electronic product for 
purposes other than subleasing.
    (u) State means a State, the District of Columbia, the Commonwealth 
of Puerto Rico, the Virgin Islands, Guam, and American Samoa.

PART 1002--RECORDS AND REPORTS

    3. The authority citation for 21 CFR part 1002 is revised to read 
as follows:

    Authority: Secs. 502, 510, 519, 520, 531-542, 701, 704 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352, 360, 360i, 
360j, 360hh-360ss, 371, 374).

    4. Section 1002.1 is revised to read as follows:

Sec. 1002.1  Applicability.

    The provisions of this part are applicable as follows:

    (a) All manufacturers of electronic products are subject to 
Sec. 1002.20.
    (b) Manufacturers, dealers, and distributors of electronic products 
are subject to the provisions of part 1002 as set forth in Table 1 of 
this section, unless excluded by paragraph (c) of this section, or 
unless an exemption has been granted under Sec. 1002.50 or 
Sec. 1002.51.
    (c) The requirements of part 1002 as specified in Table 1 of this 
section are not applicable to:

    (1) Manufacturers of electronic products intended solely for export 
if such product is labeled or tagged to show that the product meets all 
the applicable requirements of the country to which such product is 
intended for export.
    (2) Manufacturers of electronic products listed in Table 1of this 
section if such product is sold exclusively to other manufacturers for 
use as components of electronic products to be sold to purchasers, with 
the exception that the provisions are applicable to those manufacturers 
certifying components of diagnostic x-ray systems pursuant to 
provisions of Sec. 1020.30(c) of this chapter.
    (3) Manufacturers of electronic products that are intended for use 
by the U.S. Government and whose function or design cannot be divulged 
by the manufacturer for reasons of national security, as evidenced by 
government security classification.
    (4) Assemblers of diagnostic x-ray equipment subject to the 
provisions of Sec. 1020.30(d) of this chapter, provided the assembler 
has submitted the report required by Sec. 1020.30(d)(1) or (d)(2) of 
this chapter and retains a copy of such report for a period of 5 years 
from its date.

                                                                                                                

[[Page 48383]]
                                                                                                                                                        
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                 Table 1.--Record and Reporting Requirements By Product                                                 
---------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Manufacturer                                                                      
---------------------------------------------------------------------------------------------------------------------------------------------------------
                                     Supplemental     Abbreviated                                           Distribution         Dealer Distributor--   
    Products      Product reports    reports Sec.    reports Sec.   Annual reports   Test records Sec.      records Sec.         Distribution records   
                    Sec. 1002.10       1002.11          1002.12      Sec. 1002.13       1002.30(a)1         1002.309(b)2         1002.40 and 1002.41    
--------------------------------------------------------------------------------------------------------------------------------------------------------
 DIAGNOSTIC X     ...............  ...............  ..............  ..............  ..................  ...................  ...........................
 RAY3 (1020,30,                                                                                                                                         
 1020,31,                                                                                                                                               
 1020.32,                                                                                                                                               
 1020.33)                                                                                                                                               
 Computed         X                X                ..............  X               X                   X                    X                          
 tomography                                                                                                                                             
X-ray system4     X                X                ..............  X               X                   X                    X                          
Tube housing      X                X                ..............  X               X                   X                    ...........................
 assembly                                                                                                                                               
X-ray control     X                X                ..............  X               X                   X                    X                          
X-ray high        X                X                ..............  ..............  X                   X                    X                          
 voltage                                                                                                                                                
 generator                                                                                                                                              
X-ray table or    ...............  ...............  X               ..............  X                   X                    X                          
 cradle                                                                                                                                                 
X-ray film        ...............  ...............  X               ..............  X                   X                    X                          
 changer                                                                                                                                                
Vertical          ...............  ...............  X               ..............  X                   X                    X                          
 cassette                                                                                                                                               
 holders mounted                                                                                                                                        
 in a fixed                                                                                                                                             
 location and                                                                                                                                           
 cassette                                                                                                                                               
 holders with                                                                                                                                           
 front panels                                                                                                                                           
Beam-limiting     X                X                ..............  X               X                   X                    X                          
 devices                                                                                                                                                
Spot-film         X                X                ..............  X               X                   X                    X                          
 devices and                                                                                                                                            
 image                                                                                                                                                  
 intensifiers                                                                                                                                           
 manufactured                                                                                                                                           
 after April 26,                                                                                                                                        
 1977                                                                                                                                                   
Cephalometric     ...............  ...............  X               ..............  X                   X                    ...........................
 devices                                                                                                                                                
 manufactured                                                                                                                                           
 after February                                                                                                                                         
 25, 1978                                                                                                                                               
Image receptor    ...............  ...............  X               ..............  X                   X                    ...........................
 support devices                                                                                                                                        
 for                                                                                                                                                    
 mammographic x-                                                                                                                                        
 ray systems                                                                                                                                            
 manufactured                                                                                                                                           
 after September                                                                                                                                        
 5, 1978                                                                                                                                                
CABINET X RAY     ...............  ...............  ..............  ..............  ..................  ...................  ...........................
 (Sec. 1020.40)                                                                                                                                         
Baggage           X                X                ..............  X               X                   X                    X                          
 inspection                                                                                                                                             
Other             X                X                ..............  X               X                   X                    ...........................

[[Page 48384]]
                                                                                                                                                        
PRODUCTS          ...............  ...............  ..............  ..............  ..................  ...................  ...........................
 INTENDED TO                                                                                                                                            
 PRODUCE                                                                                                                                                
 PARTICULATE                                                                                                                                            
 RADIATION OR X-                                                                                                                                        
 RAYS OTHER THAN                                                                                                                                        
 DIAGNOSTIC OR                                                                                                                                          
 CABINET X-RAY                                                                                                                                          
Medical           ...............  ...............  X               X               X                   X                    ...........................
Analytical        ...............  ...............  X               X               X                   X                    ...........................
Industrial        ...............  ...............  X               X               X                   X                    ...........................
TELEVISION        ...............  ...............  ..............  ..............  ..................  ...................  ...........................
 PRODUCTS (Sec.                                                                                                                                         
 1020.10)                                                                                                                                               
<25 kilovolt      ...............  ...............  X               X6              ..................  ...................  ...........................
 (kV) and <0.1                                                                                                                                          
 millroentgen                                                                                                                                           
 per hour (mR/hr                                                                                                                                        
 IRLC1,2                                                                                                                                                
=24kV  X                X                ..............  X               X                   X                    ...........................
 and <0.1mR/hr                                                                                                                                          
 IRLC5                                                                                                                                                  
=0.1m  X                X                ..............  X               X                   X                    ...........................
 R/hr IRLC5                                                                                                                                             
MICROWAVE/RF      ...............  ...............  ..............  ..............  ..................  ...................  ...........................
MW ovens (Sec.    X                X                ..............  X               X                   X                    ...........................
 1030.10)                                                                                                                                               
MW diathermy      ...............  ...............  X               ..............  ..................  ...................  ...........................
MW heating,       ...............  ...............  X               ..............  ..................  ...................  ...........................
 drying,                                                                                                                                                
 security                                                                                                                                               
 systems                                                                                                                                                
RF sealers,       ...............  ...............  X               ..............  ..................  ...................  ...........................
 electromagnetic                                                                                                                                        
 induction and                                                                                                                                          
 heating                                                                                                                                                
 equipment,                                                                                                                                             
 dielectric                                                                                                                                             
 heaters (2-500                                                                                                                                         
 megahertz)                                                                                                                                             
OPTICAL           ...............  ...............  ..............  ..............  ..................  ...................  ...........................
Phototherapy      X                X                ..............  ..............  ..................  ...................  ...........................
 products                                                                                                                                               
Laser products    ...............  ...............  ..............  ..............  ..................  ...................  ...........................
 (Secs. 1040.10,                                                                                                                                        
 1040.11)                                                                                                                                               
Class I lasers    X                ...............  ..............  X               X                   ...................  ...........................
 and products                                                                                                                                           
 containing such                                                                                                                                        
 lasers2                                                                                                                                                
Class I laser     X                ...............  ..............  X               X                   X                    ...........................
 products                                                                                                                                               
 containing                                                                                                                                             
 class IIa, II,                                                                                                                                         
 IIIa, lasers7                                                                                                                                          

[[Page 48385]]
                                                                                                                                                        
Class IIa, II,    X                ...............  X               X               X                   X                                               
 IIIa lasers and                                                                                                                                        
 products other                                                                                                                                         
 than class I                                                                                                                                           
 products                                                                                                                                               
 containing such                                                                                                                                        
 lasers7DX                                                                                                                                             
Class IIIb and    X                X                ..............  X               X                   X                    X                          
 IV lasers and                                                                                                                                          
 products                                                                                                                                               
 containg such                                                                                                                                          
 lasers7                                                                                                                                                
Sunlamp products  ...............  ...............  ..............  ..............  ..................  ...................  ...........................
 (Sec. 1040.20)                                                                                                                                         
Lamp only         X                ...............  ..............  ..............  ..................  ...................  ...........................
Sunlamp products  X                X                ..............  X               X                   X                    X                          
Mercury vapor     ...............  ...............  ..............  ..............  ..................  ...................  ...........................
 lamps (Sec.                                                                                                                                            
 1040.30)                                                                                                                                               
T lamps           X                X                ..............  X               ..................  ...................  ...........................
R lamps           ...............  ...............  X               ..............  ..................  ...................  ...........................
ACOUSTIC          ...............  ...............  ..............  ..............  ..................  ...................  ...........................
Ultrasonic        X                X                ..............  X               X                   X                    X                          
 therapy                                                                                                                                                
 (1050.10)                                                                                                                                              
Diagnostic        ...............  ...............  X               ..............  ..................  ...................  ...........................
 ultrasound                                                                                                                                             
Medical           X                X                ..............  ..............  ..................  ...................  ...........................
 ultrasound othe                                                                                                                                        
 than therapy or                                                                                                                                        
 diagnostic                                                                                                                                             
Nonmedical        ...............  ...............  X               ..............  ..................  ...................  ...........................
 ultrasound                                                                                                                                             
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\However, authority to inspect all appropriate documents supporting the adequacy of a manufacturer's compliance testing program is retained.          
\2\The requirement includes Secs. 1002.31 and 1002.42, if applicable.                                                                                   
\3\Report of Assembly (Form FDA 2579) is required for diagnostic x-ray components; see 21 CFR 1020.30(d)(1) through (d)(3).                             
\4\Systems records and reports are required if a manufacturer exercises the option and certifies the system as permitted in 21 CFR 1020.30(c).          
\5\Determined using the isoexposure rate limit curve (IRLC) under phase III test conditions (1020.10(c)(3)(iii)).                                       
\6\Annual report is for production status information only.                                                                                             
\7\Determination of the applicable reporting category for a laser product shall be based on the worst-case hazard present within the laser product.     




Sec. 1002.2  [Removed]-

    5. Section 1002.2 Definitions is removed from subpart A.
    6. Section 1002.3 is revised to read as follows:


Sec. 1002.3  Notification to user of performance and technical data.

    As authorized by Sec. 5.90 of this chapter, the Director and Deputy 
Director of the Center for Devices and Radiological Health may require 
a manufacturer of a radiation emitting electronic product, to provide 
to the ultimate purchaser at the time of original purchase, such 
performance data and other technical data related to safety of the 
product as the Director or Deputy Director finds necessary.
    7. Section 1002.7 is amended by adding a new sentenceto the end of 
the introductory text, by revising the first sentence in paragraph (b), 
and by adding new paragraph (c) to read as follows:

Sec. 1002.7  Submission of data and reports.

    * * * The submissions required by this part shall be addressed to 
the Center for Devices and Radiological Health, Electronic Product 
Reports, Office of Compliance (HFZ-307), 2098 Gaither Rd., Rockville, 
MD 20850.
* * * * *
    (b) Where guides or instructions have been issued by the Director 
for the submission of material required by this part, such as test 
data, product reports, abbreviated reports, supplemental reports, and 
annual reports, the material submitted shall conform to the applicable 
reporting guides or instructions.
* * *
    (c) Where the submission of quality control and testing information 
is common to more than one model, or model family of the same product 

[[Page 48386]]
category, a ``common aspects report'' consolidating similar information 
may be provided, if applicable.
    8. Subpart B, consisting of Secs. 1002.10 through 1002.13, is 
revised to read as follows:

Subpart B--Required Manufacturers' Reports for Listed Electronic 
Products

Sec.
  1002.10 Product reports.
  1002.11 Supplemental reports.
  1002.12 Abbreviated reports.
  1002.13 Annual reports.

Subpart B--Required Manufacturers' Reports for Listed Electronic 
Products


Sec. 1002.10  Product reports.

    Every manufacturer of a product or component requiring aproduct 
report as set forth in Table 1 of Sec. 1002.1 shall submit a product 
report to the Center for Devices and Radiological Health, Electronic 
Product Reports, Office of Compliance (HFZ-307), 2098 Gaither Rd., 
Rockville, MD 20850, prior to the introduction of such product into 
commerce. The report shall be distinctly marked ``Radiation Safety 
Product Report of (name of manufacturer)'' and shall:
    (a) Identify which listed product is being reported.
    (b) Identify each model of the listed product together with 
sufficient information concerning the manufacturer's code or other 
system of labeling to enable the Director to determine the place of 
manufacture.
    (c) Include information on all components and accessories provided 
in, on, or with the listed product that may affect the quantity, 
quality, or direction of the radiation emissions.
    (d) Describe the function, operational characteristics affecting 
radiation emissions, and intended and known uses of each model of the 
listed product.
    (e) State the standard or design specifications, if any, for each 
model with respect to electronic product radiation safety. Reference 
may be made to a Federal standard, if applicable.
    (f) For each model, describe the physical or electrical 
characteristics, such as shielding or electronic circuitry, 
incorporated into the product in order to meet the standards or 
specifications reported pursuant to paragraph (e) of this section.
    (g) Describe the methods and procedures employed, if any, in 
testing and measuring each model with respect to electronic product 
radiation safety, including the control of unnecessary, secondary, or 
leakage electronic product radiation, the applicable quality control 
procedures used for each model, and the basis for selecting such 
testing and quality control procedures.
    (h) For those products which may produce increased radiation with 
aging, describe the methods and procedures used, and frequency of 
testing of each model for durability and stability with respect to 
electronic product radiation safety. Include the basis for selecting 
such methods and procedures, or for determining that such testing and 
quality control procedures are not necessary.
    (i) Provide sufficient results of the testing, measuring, and 
quality control procedures described in accordance with paragraphs (g) 
and (h) of this section to enable the Director to determine the 
effectiveness of those test methods and procedures.
    (j) Report for each model all warning signs, labels, and 
instructions for installation, operation, and use that relate to 
electronic product radiation safety.
    (k) Provide, upon request, such other information as the Director 
may reasonably require to enable him/her to determine whether the 
manufacturer has acted or is acting in compliance with the Act and any 
standards prescribed thereunder, and to enable the Director to carry 
out the purposes of the Act.


Sec. 1002.11  Supplemental reports.

    Prior to the introduction into commerce of a new or modified model 
within a model or chassis family of a product listed in Table 1 of 
Sec. 1002.1 for which a report under Sec. 1002.10 is required, each 
manufacturer shall submit a report with respect to such new or modified 
model describing any changes in the information previously submitted in 
the product report. Reports will be required for changes that:
    (a) Affect actual or potential radiation emission.
    (b) Affect the manner of compliance with a standard or manner of 
testing for radiation safety.


Sec. 1002.12  Abbreviated reports.

    Manufacturers of products requiring abbreviated reports as 
specified in Table 1 of Sec. 1002.1 shall submit, prior to the 
introduction of such product, a report distinctly marked ``Radiation 
Safety Abbreviated Report'' which shall include:
    (a) Firm and model identification.
    (b) A brief description of operational characteristics that affect 
radiation emissions, transmission, or leakage or that control exposure.
    (c) A list of applications or uses.
    (d) Radiation emission, transmission, or leakage levels.
    (e) If necessary, additional information as may be requested to 
determine compliance with the Act and this part.


Sec. 1002.13  Annual reports.

    (a) Every manufacturer of products requiring an annual report as 
specified in Table 1 of Sec. 1002.1 shall submit an annual report 
summarizing the contents of the records required to be maintained by 
Sec. 1002.30(a) and providing the volume of products produced, sold, or 
installed.
    (b) Reports are due annually by September 1. Such reports shall 
cover the 12-month period ending on June 30 preceding the due date of 
the report.
    (c) New models of a model family that do not involve changes in 
radiation emission or requirements of a performance standard do not 
require supplemental reports prior to introduction into commerce. These 
model numbers should be reported in quarterly updates to the annual 
report.
    9. Section 1002.20 is amended by adding a sentence at the end of 
paragraph (c) to read as follows:

Sec. 1002.20  Reporting of accidental radiation occurrences.

* * * * *
    (c) * * * A manufacturer need not file a separate report under this 
section if an incident involving an accidental radiation occurrence is 
associated with a defect or noncompliance and is reported pursuant to 
Sec. 1003.10 of this chapter.
    10. Section 1002.30 is amended in the first sentence of paragraph 
(a) introductory text, by removing ``paragraphs (b) and (c) of 
Sec. 1002.61'' and adding in its place ``Table 1 of Sec. 1002.1''; and 
adding new paragraph (a)(5) to read as follows:

Sec. 1002.30  Records to be maintained by manufacturers.

    (a) * * *
    (5) Data on production and sales volume levels if available.
* * * * *


Sec. 1002.31  [Amended]

    11. Section 1002.31 Preservation and inspection of records is 
amended in paragraph (c) by removing ``paragraph (c) of Sec. 1002.61'' 
and adding in its place ``Table 1 of Sec. 1002.1''.
    12. Section 1002.40 is amended by revising paragraph (a) to read as 
follows:

Sec. 1002.40  Records to be obtained by dealers and distributors.

    (a) Dealers and distributors of electronic products for which there 
are performance standards and for which 

[[Page 48387]]
the retail price is $50 or more shall obtain such information as is 
necessary to identify and locate first purchasers if the product is 
subject to this section by virtue of Table 1 of Sec. 1002.1.
* * * * *
    13. Section 1002.50 is revised to read as follows:


Sec. 1002.50  Special exemptions.

    (a) Manufacturers of electronic products may submit to the Director 
a request, together with accompanying justification, for exemption from 
any requirements listed in Table 1 of Sec. 1002.1. The request must 
specify each requirement from which an exemption is requested. In 
addition to other information that is required, the justification must 
contain documented evidence showing that the product or product type 
for which the exemption is requested does not pose a public health risk 
and meets at least one of the following criteria:
    (1) The products cannot emit electronic product radiation in 
sufficient intensity or of such quality, under any conditions of 
operation, maintenance, service, or product failure, to be hazardous;
    (2) The products are produced in small quantities;
    (3) The products are used by trained individuals and are to be used 
by the same manufacturing corporation or for research, investigation, 
or training.
    (4) The products are custom designed and used by trained 
individuals knowledgeable of the hazards; or
    (5) The products are produced in such a way that the requirements 
are inappropriate or unnecessary.
    (b) The Director may, subject to any conditions that the Director 
deems necessary to protect the public health, exempt manufacturers from 
all or part of the record and reporting requirements of this part on 
the basis of information submitted in accordance with paragraph (a) of 
this section or such other information which the Director may possess 
if the Director determines that such exemption is in keeping with the 
purposes of the Act.
    (c) The Director will provide written notification of the reason 
for any denial. If the exemption is granted, the Director will provide 
written notification of:
    (1) The electronic product or products for which the exemption has 
been granted;
    (2) The requirements from which the product is exempted; and
    (3) Such conditions as are deemed necessary to protect the public 
health and safety. Copies of exemptions shall be available upon request 
from the Office of Compliance (HFZ-307), Center for Devices and 
Radiological Health, 2098 Gaither Rd., Rockville, MD 20850.
    (d) The Director may, on the Director's own motion, exempt certain 
classes of products from the reporting requirements listed in Table 1 
of Sec. 1002.1, provided that the Director finds that such exemption is 
in keeping with the purposes of the act.
    (e) Manufacturers of products for which there is no applicable 
performance standard under parts 1020 through 1050 of this chapter and 
for which an investigational device exemption has been approved under 
Sec. 812.30 of this chapter or for which a premarket approval 
application has been approved in accordance with Sec. 814.44(d) of this 
chapter are exempt from submitting all reports listed in Table 1 of 
Sec. 1002.1.

Subpart G--[Removed]

    14. Subpart G, consisting of Sec. 1002.61 List of specific product 
groups, is removed.

    Dated: September 11, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-23130 Filed 9-18-95; 8:45 am]
BILLING CODE 4160-01-F