[House Report 104-436]
[From the U.S. Government Publishing Office]




                           [COMMITTEE PRINT]

                                                 Union Calendar No. 211

        104th Congress, 1st Session -  -  -  -  -  -  -  -  -  - House 
Report 104-436

 
 THE FDA FOOD ADDITIVE REVIEW PROCESS: BACKLOG AND FAILURE TO OBSERVE 
                           STATUTORY DEADLINE

                               __________

                             FOURTH REPORT

                                 by the

                        COMMITTEE ON GOVERNMENT
                          REFORM AND OVERSIGHT


                             together with


                            ADDITIONAL VIEWS

                                     


                                     

 December 21, 1995.--Committed to the Committee of the Whole House on 
            the State of the Union and ordered to be printed
              COMMITTEE ON GOVERNMENT REFORM AND OVERSIGHT

     WILLIAM F. CLINGER, Jr., 
      Pennsylvania, Chairman
                                     BENJAMIN A. GILMAN, New York
                                     DAN BURTON, Indiana
                                     J. DENNIS HASTERT, Illinois
                                     CONSTANCE A. MORELLA, Maryland
                                     CHRISTOPHER SHAYS, Connecticut
                                     STEVEN SCHIFF, New Mexico
                                     ILEANA ROS-LEHTINEN, Florida
                                     WILLIAM H. ZELIFF, Jr., New 
                                     Hampshire
                                     JOHN M. McHUGH, New York
                                     STEPHEN HORN, California
                                     JOHN L. MICA, Florida
                                     PETER BLUTE, Massachusetts
                                     THOMAS M. DAVIS, Virginia
                                     DAVID M. McINTOSH, Indiana
                                     JON D. FOX, Pennsylvania
                                     RANDY TATE, Washington
                                     DICK CHRYSLER, Michigan
                                     GIL GUTKNECHT, Minnesota
                                     MARK E. SOUDER, Indiana
                                     WILLIAM J. MARTINI, New Jersey
                                     JOE SCARBOROUGH, Florida
                                     JOHN B. SHADEGG, Arizona
                                     MICHAEL PATRICK FLANAGAN, Illinois
                                     CHARLES F. BASS, New Hampshire
                                     STEVEN C. LaTOURETTE, Ohio
                                     MARSHALL ``MARK'' SANFORD, South 
                                     Carolina
CARDISS COLLINS, Illinois            ROBERT L. EHRLICH, Jr., Maryland
HENRY A. WAXMAN, California
TOM LANTOS, California
ROBERT E. WISE, Jr., West Virginia
MAJOR R. OWENS, New York
EDOLPHUS TOWNS, New York
JOHN M. SPRATT, Jr., South Carolina
LOUISE McINTOSH SLAUGHTER, New York
PAUL E. KANJORSKI, Pennsylvania
GARY A. CONDIT, California
COLLIN C. PETERSON, Minnesota
KAREN L. THURMAN, Florida
CAROLYN B. MALONEY, New York
THOMAS M. BARRETT, Wisconsin
GENE TAYLOR, Mississippi
BARBARA-ROSE COLLINS, Michigan
ELEANOR HOLMES NORTON, District of Columbia
JAMES P. MORAN, Virginia
GENE GREEN, Texas
CARRIE P. MEEK, Florida
CHAKA FATTAH, Pennsylvania
BILL BREWSTER, Oklahoma
TIM HOLDEN, Pennsylvania
            ------
BERNARD SANDERS, Vermont (Independent)

  James L. Clarke, Staff Director
    Kevin Sabo, General Counsel
     Judith McCoy, Chief Clerk
Bud Myers, Minority Staff Director
_________________________________________________________________

    Subcommittee on Human Resources and Intergovernmental Relations

 CHRISTOPHER SHAYS, Connecticut, 
             Chairman
                                     MARK E. SOUDER, Indiana
                                     STEVEN SCHIFF, New Mexico
                                     CONSTANCE A. MORELLA, Maryland
                                     THOMAS M. DAVIS, Virginia
                                     DICK CHRYSLER, Michigan
                                     WILLIAM J. MARTINI, New Jersey
                                     JOE SCARBOROUGH, Florida
                                     MARSHALL ``MARK'' SANFORD, South 
EDOLPHUS TOWNS, New York             Carolina
TOM LANTOS, California
BERNARD SANDERS, Vermont (Ind.)
THOMAS M. BARRETT, Wisconsin
GENE GREEN, Texas
CHAKA FATTAH, Pennsylvania
HENRY A. WAXMAN, California

                               Ex Officio

                                     WILLIAM F. CLINGER, Jr., 
CARDISS COLLINS, Illinois            Pennsylvania
 Lawrence Halloran, Staff Director
 Anne Marie Finley, Professional 
           Staff Member
        Thomas Costa, Clerk
     Cheryl Phelps, Minority 
        Professional Staff

                                  (ii)

  
                         LETTER OF TRANSMITTAL

                              ----------                              

                                  House of Representatives,
                                 Washington, DC, December 21, 1995.
Hon. Newt Gingrich,
Speaker of the House of Representatives,
Washington, DC.
    Dear Mr. Speaker: By direction of the Committee on 
Government Reform and Oversight, I submit herewith the 
committee's fourth report to the 104th Congress.

                                   William F. Clinger, Jr.,
                                                          Chairman.

                                 (iii)


                            C O N T E N T S

                              ----------                              
                                                                   Page
I. Summary.......................................................     1
II. Background...................................................     2
III. Findings....................................................     6
IV. Recommendations..............................................    10

                                 VIEWS

Additional views of Hon. David M. McIntosh and Hon. Mark E. 
  Souder.........................................................    14

                                  (v)
                                                 Union Calendar No. 211
104th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES

 1st Session                                                    104-436
_______________________________________________________________________

 THE FDA FOOD ADDITIVE REVIEW PROCESS: BACKLOG AND FAILURE TO OBSERVE 
                           STATUTORY DEADLINE

                                _______


 December 21, 1995.--Committed to the Committee of the Whole House on 
            the State of the Union and ordered to be printed

_______________________________________________________________________


  Mr. Clinger, from the Committee on Government Reform and Oversight, 
                        submitted the following

                             FOURTH REPORT

    On December 14, 1995, the Committee on Government Reform 
and Oversight approved and adopted a report entitled ``The FDA 
Food Additive Review Process: Backlog and Failure To Observe 
Statutory Deadline.'' The chairman was directed to transmit a 
copy to the Speaker of the House.

                           I. SUMMARY

    Food additive petitions must be reviewed and acted upon by 
the Food and Drug Administration (FDA) ``not more than 180 days 
after the date of filing of the petition.'' \1\ The statutory 
deadline is not being met and statutory changes are needed to 
establish more realistic and binding time frames for petition 
reviews. The regulatory scheme in the United States for food 
additive review is dysfunctional, and as a result, the American 
consumer and patient are deprived of technologies that will 
increase the variety and nutritional benefits of foods, improve 
diet and advance public health.
    \1\ 21 U.S.C. 348 (c) (2).
---------------------------------------------------------------------------

Findings:

    1. FDA does not meet the 180 day statutory deadline to 
review and make a decision on food additive petitions.
    2. There were 295 pending food additive petitions (direct, 
indirect, and generally recognized as safe (GRAS)), some of 
which were filed in the 1970s, as of June 22, 1995.
    3. The lack of fixed deadlines and the increased scientific 
ability to detect and measure potential hazards have resulted 
in a review process that is risk-averse.
    4. FDA is reluctant to decline incomplete or inadequate 
petitions, and consequently, allows incomplete and inadequate 
petitions to remain under review at FDA for more than 180 days.
    5. FDA has committed insufficient resources to its food 
additive review responsibilities.
    6. FDA does not set food additive petition review 
priorities appropriately.
    7. FDA's failure to expeditiously review food additive 
petitions has stifled innovation and introduction of new 
ingredients by the food industry.
    8. A petition review process with no fixed deadlines can be 
manipulated for anti-competitive purposes.
    9. FDA does not make sufficient use of independent 
scientific resources for food additive petition review.

Recommendations:

    1. Congress should amend the Federal Food, Drug and 
Cosmetic Act review period for food additive petitions, from 
180 to 360 days for the most scientifically complex reviews, 
and the deadline should be strictly observed by FDA.
    2. The FDA should recognize that the approval of useful and 
safe new products can be as important to the public health as 
preventing the marketing of harmful or ineffective products.
    3. The FDA should eliminate the backlog of pending food 
additive petitions within one year by reallocating the 
necessary agency resources.
    4. The FDA should utilize outside expertise in its 
evaluation of food additive petitions but retain authority for 
petition approval.
    5. The relevance of the Delaney clause should be studied in 
view of modern scientific standards so t hat better 
distinctions can be made between nominal hazards and actual 
risks.
    6. The FDA should amend the review process to prohibit 
anonymous submissions of data or comments.

                         II. BACKGROUND

    The Human Resources and Intergovernmental Relations (HRIR) 
Subcommittee began an oversight investigation into the delays 
in the Food and Drug Administration's (FDA) review and decision 
making on food additive petitions in April, 1995. This was the 
first comprehensive oversight investigation into the FDA's 
management of the food additives program since the food 
additive amendments were passed in 1958.
    The Subcommittee sent document requests to FDA on April 13, 
April 17, and June 12, 1995. Oversight briefings with FDA were 
held May 23, June 5, June 9, June 16, June 19, and June 21, 
1995. Academicians, former FDA Center for Food Safety and 
Applied Nutrition (CFSAN) employees, food manufacturers, trade 
associations, food scientists, and consumer groups were 
interviewed by the subcommittee staff. HRIR subcommittee 
hearings were held on June 22 and June 29, 1995.
    After the June 22 hearing, a letter from Chairman 
Christopher Shays and Ranking Member Edolphus Towns was sent to 
Health and Human Services (HHS) Secretary Donna E. Shalala on 
June 26, 1995, requesting a legislative proposal that would 
establish a statutory standard which the FDA could meet in its 
review of food additive petitions. A follow up letter was sent 
on August 29, 1995, after no response was received from HHS. A 
response was received on September 13, 1995. FDA briefed 
Subcommittee staff on October 2, 1995, on the agency's 
legislative proposal to rectify the food additive review 
delays.
    The FDA proposes a statutory change which would extend the 
review period from the current 180 days to 360 days. The agency 
is committed to reviewing 90% of the petitions within 180 days 
and proposes administrative performance goals to keep no more 
than 10% of petitions under review for up to 360 days.
    The agency also supports statutory changes which would 
effect streamlining of the rulemaking process for both food and 
color additives, increased use of outside experts for review of 
food and color additive petitions (through amendment of the 
Federal Advisory Committee Act \2\ (FACA)) and conforming 
amendments for color additives to harmonize deadlines of both 
food and color additive petitions.
    \2\ (5 U.S.C. App.) P.L. 92-463, 86 Stat. 770, Oct. 6, 1972.
---------------------------------------------------------------------------
    The agency will put more resources and Full Time Equivalent 
(FTE) positions into the petition review process. The agency 
may propose user fees to fund pre-filing consultation 
activities with sponsors.\3\
    \3\ HRIR interview with FDA Deputy Commissioner William Schultz, 
October 2, 1995.
---------------------------------------------------------------------------
    The Federal Food, Drug, and Cosmetic Act (FFDCA) of 1938 
gave the Food and Drug Administration (FDA) authority over food 
and food ingredients. The Food Additive Amendments to the FFDCA 
were passed by Congress in 1958 to require FDA's pre-market 
approval for the use of an additive prior to its inclusion in 
food. This authority is now found in section 409 of the 
FFDCA.\4\
    \4\ 21 U.S.C. 348.
---------------------------------------------------------------------------
    An additive is defined as ``any substance the intended use 
of which results or may reasonably be expected to result, 
directly or indirectly, in its becoming a component or 
otherwise affecting the characteristics of any food.'' This 
definition covers any substance used in the production, 
processing, treatment, packaging, transportation or storage of 
food such as colors, packaging materials, artificial sweeteners 
and fat substitutes.
    Food additives are commonly used to: impart or maintain 
desired consistency, improve or maintain nutritive value, 
maintain palatability and wholesomeness, produce texture, 
control acidity/alkalinity and enhance flavor or impart color. 
Direct additives are added to food for a specific purpose, such 
as a fat replacer or artificial sweetener. High profile direct 
additive petitions under review at FDA include: Johnson and 
Johnson's (McNeil division) SUCRALOSE artificial sweetener and 
Proctor and Gamble's OLESTRA fat replacer.
    Indirect additives may become part of the food in trace 
amounts due to packaging, storing or other handling. The law 
also requires the manufacturer to prove an additive's safety 
for the ways it will be used in foods, such as for fat 
replacement, fiber addition, or as a sweetener.
    The statutory standard is rigorous but not absolute. An 
additive is deemed safe if the sponsor proves to a ``reasonable 
certainty that no harm would result from the substance under 
its intended conditions of use.'' The amendments also included 
the Delaney clause which stipulates that ``no food additive can 
be deemed safe if it has been found to induce cancer when 
ingested by man or animals.'' \5\
    \5\ Pub. L. No. 85-929, 4, 72 Stat. 1785 (1958), as amended, 21 
U.S.C. 348(c) (3) (A) (1982).
---------------------------------------------------------------------------
    Two groups of substances were exempt from the Food 
Additives Amendments. They included substances sanctioned by 
FDA or USDA prior to 1958, such as calcium propionate,\6\ and 
substances considered generally recognized as safe (GRAS), such 
as salt, sugar, spices, vitamins, etc.\7\
    \6\ Section 201 (s) (4) of the FFDCA, 21 U.S.C. 321 (s) (4).
    \7\ 21 CFR 182.1 (a).
---------------------------------------------------------------------------
    Food additive petitions must be reviewed and acted upon 
``not more than 180 days after the date of filing of the 
petition.'' \8\ Upon approval of a food additive petition, FDA 
issues regulations including the types of foods in which an 
additive can be used, the maximum amounts to be used, and how 
additives must be listed on food labels. Meat and poultry 
additives are reviewed by USDA and FDA.
    \8\ 21 U.S.C. 348 (c) (2).
---------------------------------------------------------------------------

                         A. THE REVIEW PROCESS

    A sponsor who seeks to market a food additive must submit a 
petition to FDA establishing that the substance is safe for its 
intended use and that it performs its intended function. FDA 
evaluates the adequacy of the petition for evaluation and the 
need for scientific evaluation outside FDA's Center for Food 
Safety and Applied Nutrition (CFSAN). The petition is 
simultaneously reviewed by the Division of Product 
Manufacturing, the Division of Health Effects Evaluation, the 
Division of Molecular Biology and other CFSAN offices as 
determined by CFSAN's Office of Premarket Approval at the time 
of submission.
    Under the National Environmental Policy Act (NEPA), FDA 
must evaluate the potential environmental effects of the 
substance and include this evaluation in its decision-making. A 
safety determination is made, an administrative record is 
compiled and a rule is drafted. The petition receives a legal 
review by FDA General Counsel and a policy review by the Office 
of the Commissioner before publication in the Federal Register 
and then in the Code of Federal Regulations. A food additive 
regulation is not a product license limited to a single sponsor 
or manufacturer. Any manufacturer may market an approved food 
additive under approved conditions of use.\9\
    \9\ HRIR Hearings, p. 5 (testimony of Linda Suydam).
---------------------------------------------------------------------------
    Few, if any, food additive petitions are acted upon in the 
statutorily-prescribed time period. Frequently, food additive 
petitions remain in pending status, while the agency asks for 
more data. At a meeting on June 16, 1995 with Subcommittee 
staff, FDA Deputy Commissioner for Policy William Schultz 
stated that the 180 day review period was unrealistic and that 
he felt no one in industry or at the FDA thought it realistic 
to expect reviews to be completed in 180 days.

                        B. FOOD ADDITIVE DELAYS

    FDA has a backlog of 295 food additive petitions under 
review, some of which have been pending since the 1970s. 
Approximately 100 new food and color additive petitions are 
submitted to the FDA each year.
    Indirect additives comprise approximately half of all 
pending petitions, and are believed by many industry sources to 
be languishing due to low priority within the Center.\10\ 
Direct additives comprise approximately 17% of pending 
petitions and may be under review for up to 10 years while 
agency reviewers ascertain their safety, often with repeated 
requests for additional animal studies and safety data.
    \10\ Delays in the FDA's Food Additive Petition Process and GRAS 
Affirmation Process: Hearings Before the Subcommittee on Human 
Resources and Intergovernmental Relations of the House Committee on 
Government Reform and Oversight, 104th Cong., 1st Sess. 131-132 (1995) 
(``HRIR Hearings'') (statement of Jerome Heckman).
---------------------------------------------------------------------------
    For example, McNeil's SUCRALOSE petition was filed with FDA 
in February, 1987, but has not yet been approved. It was filed 
in Canada and Australia in April and June, 1987, and approved 
in Canada in September, 1991. Australia's National Food 
Authority announced its intention to approve SUCRALOSE subject 
to a public comment period and consideration by the National 
Food Standards Council (which is comprised of public health 
ministers at State, Territory, and Federal levels) in December 
1991. Final Australian approval was received in October, 
1993.\11\
    \11\ McNeil chronology document in Subcommittee files.
---------------------------------------------------------------------------

                             C. GRAS DELAYS

    In March 1972, the FDA contracted with the Federation of 
American Societies of Experimental Biology (FASEB) to evaluate 
the safety and health effects of over 468 food additives 
considered generally recognized as safe or ``GRAS'' at the time 
of the 1958 amendments. In March 1982, FASEB completed its 
evaluation of 422 direct additives and 46 indirect additives. 
It determined that 339 or 72% were considered GRAS with no 
evidence of adverse health effects. Sixty-nine or 15% were GRAS 
with additional data required if increased or new uses are 
contemplated.
    Twenty-one or 5% were permitted to receive an interim food 
additive regulation requiring that testing be undertaken but 
given GRAS status until such tests are completed and evaluated. 
Five or 1% had insufficient evidence to determine if reported 
adverse health effects were not deleterious. It was recommended 
that safe conditions of use be established for these five 
additives.
    Thirty-four or 7% had inadequate data on biological studies 
which precluded evaluation. An invitation to submit data was 
recommended, and if none was received, there was a recommended 
recision of GRAS status. A number of GRAS substances reviewed 
by FASEB have yet to be acted upon by FDA.
    GRAS petitions are not required by law but are voluntarily 
submitted to obtain FDA concurrence that premarket approval is 
not required. However, due to liability concerns, processed 
foods manufacturers are increasingly unwilling to purchase GRAS 
substances without an affirmation letter from FDA. Seventy-five 
GRAS affirmation petitions are currently pending at FDA, the 
oldest of which was filed on August 31, 1972.
    On June 22, 1995, the FDA presented at the Subcommittee 
hearing an administrative plan to rectify the backlog and 
address delays in the food additives program. The plan 
included:
     reorganization of FDA's Center for Food Safety and 
Applied Nutrition (CFSAN) to place petition review resources 
under one central manager;
     development and issuance of a ``threshold of 
regulation'' approach for indirect additives that meet specific 
criteria;
     performance goals to review petitions within 
defined time periods;
     reform of the GRAS regulatory process;
     additional agency resources to reduce the 
inventory of pending petitions;
     use of external scientific expertise to expedite 
the review of pending petitions;
     elimination or reduction of requirements for 
environmental assessments for many petitions;
     expanded programs to help petitioners submit 
complete, sufficient submissions.\12\
    \12\ HRIR Hearings, p. 10-11 (statement of Linda Suydam).
---------------------------------------------------------------------------

                         III. FINDINGS

1. FDA does not meet the 180 day statutory deadline to review and make 
        a decision on food additive petitions.

    The agency views the 180 day statutory time frame as a 
goal, not a binding requirement. FDA Interim Deputy 
Commissioner for Operations Linda Suydam testified that the 
agency views the 180 day time frame as ``a target, and we try 
to meet that target.'' \13\
    \13\ HRIR Hearings, p. 26.
---------------------------------------------------------------------------
    The FDA does not meet the 180 day target. Data supplied by 
FDA at the June 22, 1995 hearing indicate that since 1970, the 
average time to approval of a direct food additive has been at 
least 20 months.\14\ FDA General Counsel Margaret Jane Porter 
stated that, in her view, the 180 day statutory limit was 
``ridiculous.'' \15\ Chairman Shays stated at the June 22 
hearing that ``the statutory deadline has been interpreted out 
of existence by the FDA, and I am eager to learn how the agency 
plans to restore accountability to the process for determining 
the safety of food additives.'' \16\
    \14\ HRIR Hearings, p. 16, FDA supplied chart.
    \15\ HRIR Hearings, p. 25.
    \16\ HRIR Hearings, p. 2 (statement of Chairman Christopher Shays).
---------------------------------------------------------------------------
    FDA testified that the establishment of performance goals 
for the food additive petition review process will provide a 
mechanism to fulfill the Agency's commitment to timely and 
predictable decision making.\17\ However, the plan submitted by 
the agency to relieve the backlog of pending petitions \18\ was 
not in compliance with the statute.\19\
    \17\ HRIR Hearings, p. 13 (statement of Linda Suydam).
    \18\ Ibid.
    \19\ HRIR Hearings, p. 25-27.
---------------------------------------------------------------------------

2. As of June 22, 1995, there were 295 pending food additive petitions 
        (direct, indirect, and GRAS), some of which were filed in the 
        1970s.

    The FDA provided the Subcommittee with a list of 295 
pending food petitions.\20\ Sixty-six percent of pending 
petitions were filed between 1990-1994, 27% between 1980-1989, 
and 7% between 1971-1979.\21\
    \20\ HRIR Hearings, p. 24, FDA supplied chart.
    \21\ Letter of May 2, 1995 FDA response to Chairman Shays inquiry 
(in subcommittee files).
---------------------------------------------------------------------------

3. The lack of fixed deadlines and the increased scientific ability to 
        detect and measure potential hazards have resulted in a review 
        process that is risk-averse.

    Under-funding and under-staffing of the CFSAN were cited by 
FDA and academic witnesses \22\ as impediments to timely 
scientific review, sound scientific judgement, and support for 
new food technologies. However, the inability of CFSAN 
reviewers to recognize the degree of actual risk, \23\ or no 
risk, posed by low levels of materials as used in practice, as 
opposed to materials which present a minimal or theoretical 
hazard at much higher levels, was also identified as an 
impediment to timely review of food petitions.\24\
    \22\ HRIR Hearings, p. 35-37 (statement of Dr. Sanford Miller).
    \23\ Ibid.
    \24\ HRIR Hearings, p. 49.
---------------------------------------------------------------------------
    The statutory charge is to determine the safety of food 
additives, applying the best science available, not an absolute 
standard of zero risk. FDA regulations define safety as ``the 
reasonable certainty in the minds of competent scientists that 
the substance is not harmful under the intended conditions of 
use. It is impossible in the present state of scientific 
knowledge to establish with complete certainty the absolute 
harmlessness of the use of any substance.'' \25\
    \25\ 21 CFR. 170. 3(i); HRIR Hearings, p. 41 (statement of Dr. 
Richard Hall).
---------------------------------------------------------------------------

4. The FDA is reluctant to decline incomplete or inadequate petitions, 
        and consequently, allows incomplete and inadequate petitions to 
        remain under review at FDA for more than 180 days.

    FDA stated that industry prefers a longer review time to a 
refusal to file or rejection of a petition.\26\ Industry is 
unwilling to push FDA for a decision on a food additive because 
companies fear rejection of the petition.\27\
    \26\ HRIR Hearings, p. 10 (statement of Linda Suydam); p. 23.
    \27\ HRIR Hearings, p. 10 (statement of Linda Suydam); p. 105-106.
---------------------------------------------------------------------------
    The quality of submitted petitions is often inadequate. FDA 
expressed support for an industry proposal that would assist 
petitioners in developing their food additive petitions prior 
to submission to the FDA.\28\ Pfizer and other food companies 
have developed a proposal to use expert scientists to review 
the scientific data of food additive petitions that are 
submitted to FDA.
    \28\ HRIR Hearings, p. 19.
---------------------------------------------------------------------------
    Under the proposal, as the petitions are submitted the 
relevant safety sections would also be submitted to expert 
panels, which would be selected and administered by an 
independent, third party institution. This plan would be funded 
by annual grants from ingredient suppliers and food companies 
and the expert panels would be funded by an assessment fee for 
each petition. Panel reports and recommendations would be 
submitted by the petitioner to the FDA but FDA would retain 
approval authority.\29\
    \29\ HRIR Hearings, p. 163 (statement of Donald Farley).
---------------------------------------------------------------------------

5. FDA has committed insufficient resources to its food additive review 
        responsibilities.

    FDA has taken resources from the food programs, which 
comprise more than 50% of the agency's responsibilities,\30\ 
and devoted them to drug and biologic reviews.\31\
    \30\ FDA Almanac FY1994, p. 68.
    \31\ HRIR Hearing, FDA Centers Personnel Chart, p. 60.
---------------------------------------------------------------------------
    Allocation of internal resources by FDA management 
jeopardizes the food programs. In FY 1994 the total FDA budget 
was $873,048,000 of which $221,648,000, or 25%, were devoted to 
food regulation.\32\ However, foods represent more than 50% of 
FDA's workload.
    \32\ FDA Almanac FY1994, FDA's Budget Chart, p. 11.
---------------------------------------------------------------------------
    The CFSAN staffing levels are about the same as 10 years 
ago after dropping to their lowest levels in FY1989. Comparison 
with budget changes for the Centers for Drugs and Biologics 
shows a 60% increase for the drug and biologics programs while 
CFSAN staffing remains at the same level.\33\
    \33\ HRIR Hearings, FDA Center Personnel Chart, p. 61.
---------------------------------------------------------------------------
    The leveling of FDA resources for foods in recent years is 
in sharp contrast with the increased responsibilities CFSAN has 
assumed due to new legislation in the areas of nutrition 
labeling,\34\ nutrition monitoring, pesticide monitoring, and 
safe transport of food. The food supply for which FDA is 
responsible has grown enormously in the number of food products 
and in diversity of source and processing since the FFDCA was 
enacted in 1906 and the food additive amendments were enacted 
in 1958.
    \34\ HRIR Hearings, p. 41 (statement of Dr. Richard Hall).
---------------------------------------------------------------------------
    The Prescription Drug User Fee Act (PDUFA) \35\ allows user 
fees to be used as a supplement to the FDA's appropriated 
budget only if FDA allocates funding for drug and biologics 
programs at 1992 inflation adjusted levels. FDA Interim Deputy 
Commissioner for Operations Linda Suydam testified that ``as a 
result (of PDUFA), the other parts of the agency's programs 
have to take cuts to make up for that large program being 
protected.'' \36\
    \35\ 21 U.S.C. 379(h).
    \36\ HRIR Hearings, p. 28.
---------------------------------------------------------------------------

6. FDA does not set food additive petition review priorities 
        appropriately.

    Seventy-five percent of food additive petitions are for 
indirect additives and 25% are for direct additives.\37\ 
Indirect additives generally require fewer resources and less 
review than direct additives.\38\ However, the FDA does not 
assign greater resources to direct petitions as opposed to 
indirect petitions, instead utilizing a ``first in, first out'' 
review system which does not devote the greatest resources to 
the applications with the greatest resource requirements.
    \37\ HRIR Hearings, p. 31.
    \38\ HRIR Hearings, p. 139-141 (statement of Jerome Heckman).
---------------------------------------------------------------------------

7. FDA's failure to expeditiously review food additive petitions has 
        stifled innovation and introduction of new ingredients by the 
        food industry.

    The food industry, which is now international in nature, is 
extremely adverse to taking risks in the introduction of new 
products. If new technologies have to undergo long periods of 
review without decision by the agency, the result is an 
industry which tends to repeat past technologies rather than 
developing new ones.\39\ Several companies told the 
Subcommittee staff in interviews that they had abandoned 
research into promising food additives because of the delays in 
the petition review process. One company testified that 
consideration had been given to ``abandoning our U.S. based 
research.'' \40\
    \39\ HRIR Hearings, p. 35-36 (statement of Dr. Sanford Miller).
    \40\ HRIR Hearings, p. 162-163 (testimony of Mr. Donald Farley).
---------------------------------------------------------------------------

8. A petition review process with no fixed deadlines can be manipulated 
        for anti-competitive purposes.

    The FDA received safety objections regarding petitions 
under review from anonymous sources which may have been 
motivated by economic, social, or political forces.\41\ 
Industry representatives believe that the review process has 
been manipulated to cause delays.\42\ FDA admitted that this is 
a problem with the current system.\43\
    \41\ HRIR Hearings, p. 40 (testimony of Dr. Richard Hall);p. 90-91; 
p. 101 (statement of Dr. Wayne Callaway); see also p. 181 (statement of 
Dr. Michael Jacobson)
    \42\ HRIR Hearings, p. 40 (testimony of Dr. Richard Hall), p. 43 
(statement of Dr. Richard Hall).
    \43\ HRIR interview with Deputy Commissioner William Schultz, 
October 2, 1995.
---------------------------------------------------------------------------

9. FDA does not make sufficient use of independent scientific resources 
        for food additive petition review.

    FDA cannot maintain sufficient scientific expertise in all 
areas necessary for review of more complicated and 
scientifically advanced petitions. Industry sources report that 
FDA review of macroingredient \44\ petitions in particular now 
requires an increasing reliance on nutritional and clinical 
studies as opposed to traditional toxicological studies in test 
animals. Therefore, FDA requires access to more human and 
veterinary medical reviewers and nutritionists as opposed to 
toxicologists.
    \44\ ``An element of carbon, hydrogen, oxygen, or nitrogen, needed 
in large amounts for plant growth and development.'' Webster's II New 
Riverside University Dictionary (1988).
---------------------------------------------------------------------------
    Toxicology reviews of food additive petitions were listed 
as a significant source of delay at FDA. Former FDA 
toxicologists and industry regulatory affairs professionals 
cited a lack of scientific resources and confidence in 
toxicology personnel.\45\ FDA has inadequate access to top-
level expertise in toxicology, especially experienced risk 
assessment personnel.\46\
    \45\ HRIR Hearings, p. 41 (statement of Dr. Richard Hall).
    \46\ HRIR Hearings, p. 163 (statement of Mr. Donald Farley).
---------------------------------------------------------------------------
    The FDA presented a plan to utilize existing contracts with 
independent, third-party scientific organizations to aid the 
agency's review of food additive petitions.\47\ In order to 
keep up with increasing industry requirements for food additive 
reviews, FDA must look outside the agency for additional 
scientific review resources to supplement agency resources.\48\
    \47\ HRIR Hearings, p. 12 (testimony of Linda Suydam).
    \48\ HRIR Hearings, p. 49.
---------------------------------------------------------------------------

                      IV. RECOMMENDATIONS

1. Congress should amend the Federal Food, Drug and Cosmetic Act review 
        period for food additive petitions, from 180 to 360 days for 
        the most scientifically complex reviews, and the deadline 
        should be strictly observed by FDA.

    The 180 day time frame has been meaningless for many years 
as evidenced by the list of 295 pending petitions submitted by 
FDA to the Subcommittee. Food manufacturers need ``some 
finality to the process of additive review . . . deadlines for 
(agency) actions that are appropriate and real, and not merely 
advisory.'' \49\
    \49\ HRIR Hearings, p. 119 (testimony of Stuart Pape).
---------------------------------------------------------------------------
    Also, the 180 day statutory deadline for FDA approval/
disapproval decisions on food additive applications is no 
longer sufficient for technologically advanced applications 
such as food products derived through biotechnology, 
macroingredients and functional foods, which are defined ``as 
any modified food or food ingredient that may provide a health 
benefit beyond the traditional nutrients it contains'' \50\ 
that provide specific health benefits.
    \50\ Journal of the American Dietetic Association, ``Position of 
the American Dietetic Association: Phytochemicals and functional 
foods,'' p. 493, April 1995 Volume 95 Number 4.
---------------------------------------------------------------------------
    The food industry would support a meaningful review 
deadline. Industry representatives presented a proposal for a 
new food additive review system with review time frames of at 
least 360 days.\51\ This proposal would, for the first time, 
permit an FDA selected independent scientific review panel to 
assess the safety of a food additive and make a recommendation 
to FDA regarding approval or disapproval.
    \51\ HRIR Hearings, p. 120 (statement of Stuart Pape).
---------------------------------------------------------------------------
    Under such a review process, the agency must either accept 
the recommendation and issue a regulation allowing use of the 
food additive or reject the recommendation and cite the reasons 
for so doing. For the first time, the review process would have 
a fixed deadline, after which a presumption of approval would 
apply. To overcome the presumption of approval, FDA would bear 
the burden of proof to rebut the third party recommendation.
    If the agency did not review and make a decision on the 
review panel's recommendation within statutorily prescribed 
time frames, the recommendation of the scientific review panel 
would become effective. The presumption of approval arising 
from a favorable recommendation from the scientific review 
organization will ensure that FDA meets the statutory deadline 
or takes final (appealable) administrative action to extend it.
    The FDA presented performance goals in testimony that 
indicate that most petitions could be reviewed by the agency 
within 360 days.\52\
    \52\ HRIR Hearings, p. 13 (statement of Linda Suydam).
---------------------------------------------------------------------------

2. The FDA should recognize that the approval of useful and safe new 
        products can be as important to the public health as preventing 
        the marketing of harmful or ineffective products. FDA's prompt 
        approval of new food petitions can also benefit the 
        environment.

    The 1988 Surgeon General's Report on Nutrition and Health 
stated that ``The public would benefit from increased 
availability of foods and food products low in calories, total 
fat, saturated fat, cholesterol, sodium and sugars.'' \53\ 
Physicians testified that many patients with chronic conditions 
would more successfully implement long-term dietary 
modifications if they had a greater variety of new foods with 
lower fat, calories, sugars, and sodium.\54\ A consumer group 
witness testified that reducing saturated fat intake by eight 
grams a day would save as much as $24 billion a year.\55\
    \53\ The Surgeon General's Report on Nutrition and Health, 1988, 
U.S. Department of Health and Human Services, p. 19.
    \54\ HRIR Hearings, p. 99-100 (statement of Dr. C. Wayne Callaway); 
p. 102 (testimony of Dr. Michael Davidson).
    \55\ HRIR Hearings, p. 182 (statement of Dr. Michael Jacobson).
---------------------------------------------------------------------------
    The FDA should implement Recommendation 1.4 of the Advisory 
Committee on the Food and Drug Administration, which states 
``FDA must recognize the approval of useful and safe new 
products can be as important to the public health as preventing 
the marketing of harmful or ineffective products. Specifically, 
the FDA should develop a flexible range of regulatory pathways, 
all of which uphold current standards of safety and efficacy, 
but which reflect the fact that not all drugs, devices and 
foods are alike.'' \56\
    \56\ Final Report of the Advisory Committee on the Food and Drug 
Administration, U.S. Department of Health and Human Services, May 1991, 
p. 14.; HRIR Hearings, p. 53 (testimony of Dr. Stephen Ziller).
---------------------------------------------------------------------------
    FDA's prompt approval of indirect food additives for use in 
new and improved food packaging can also have significant 
environmental benefits. The food industry is a primary consumer 
of packaging materials. Improvements in source reduction and 
recycling of materials can result in immediate environmental 
benefits.\57\
    \57\ HRIR Hearings, p. 92-93 (testimony of Dr. D. Stephen 
Saunders).
---------------------------------------------------------------------------

3. The FDA should eliminate the backlog of food petitions within one 
        year by reallocating the necessary resources to the food 
        petition review program.

    After the HRIR investigation into the backlog of food 
additive petitions began, FDA informed the Subcommittee staff 
that twenty-five individuals have been reassigned within CFSAN 
to work on food petitions and two toxicologists from the 
National Center for Toxicological Research (NCTR) have been 
devoted to CFSAN food petition toxicology reviews. FDA will 
hire immediate contract help to focus on chemical, 
toxicological and environmental reviews of low priority 
petitions.\58\ Furthermore, FDA testified that $7 million was 
added to the indirect additive review program to eliminate the 
backlog.\59\
    \58\ HRIR Interview with FDA Deputy Commissioner for Policy William 
Schultz; October 2, 1995.
    \59\ HRIR Hearings, p. 22 (testimony of Linda Suydam).
---------------------------------------------------------------------------

4. The FDA should utilize outside expertise in its evaluation of food 
        additive petitions in order to reach prompt and responsible 
        decisions on the safety of these products. The FDA should 
        retain responsibility for petition approvals.

    Utilization of outside scientific expertise will provide 
FDA with access to a wider range of expertise and extend the 
agency's scientific resources. FDA proposed to award a contract 
for independent third-party scientific review of some indirect 
additive petitions as part of its administrative reform 
proposal.\60\
    \60\ HRIR Hearings, p. 12 (statement of Linda Suydam).
---------------------------------------------------------------------------
    Food scientists and industry witnesses proposed a system 
whereby an independent third party scientific review 
organization may review a petition and find an additive safe 
for its intended use. FDA must concur with the scientific 
review or the agency may refuse to do so only on the basis of 
explicitly stated, substantially supported countervailing 
considerations. If FDA does not issue a regulation or report 
defending an opposing view within a prescribed time, then 
presumptive approval would become final.\61\ The FDA must 
select the appropriate extramural review group and it must set 
the criteria for selection of members of the review panels of 
these groups to avoid the appearance of a conflict of interest 
and lack of public confidence in the process.\62\
    \61\ HRIR Hearings, p. 36 (statement of Dr. Sanford Miller)
    \62\ Ibid.
---------------------------------------------------------------------------
    The agency should be encouraged to sort out those issues 
which the agency itself must resolve as opposed to those which 
may pose lesser risk and which may be scientifically reviewed 
by external groups under the agency's authority. Industry 
witnesses support retention of final decision making by the 
FDA.\63\ Consumer groups expressed support for utilization of 
third-party toxicology reviews with retention of final approval 
authority by FDA.\64\
    \63\ HRIR Hearings, p. 40, 44 (statement of Dr. Richard Hall); p. 
119 (testimony of Stuart Pape).
    \64\ HRIR Hearings, p. 175 (testimony of Dr. Michael Jacobson).
---------------------------------------------------------------------------

5. The relevance of the Delaney clause should be studied in view of 
        modern scientific standards so that better distinctions can be 
        made between nominal hazards and actual risks.

    The Delaney clause stipulates that no food additive can be 
deemed safe if it has been found to induce cancer when ingested 
by man or animals. The Delaney clause was enacted at a time 
when it was not possible to detect the presence of chemicals at 
ratios of as little as .02 parts per trillion. This scientific 
advancement may require implementation of more subtle risk 
based approaches. In addition, some substances at minimal 
levels present no risk to humans through consumption. The 
agency should establish a level of acceptable risk for food 
additives, below which there is no hazard to humans through 
consumption under normal or intended use.\65\
    \65\ HRIR Hearings, p. 50.
---------------------------------------------------------------------------

6. The FDA should amend the review process to prohibit anonymous 
        submissions of data or comments.

    Companies have utilized anonymous submissions of data to 
delay review of competitors' products.\66\ Manipulation of the 
food additive review process for anti-competitive purposes is 
inconsistent with the purposes of pre-market review. FDA should 
prohibit the consideration of information from anonymous 
sources.
    \66\ HRIR Hearings, p. 40 (testimony of Dr. Richard Hall);p. 90-91; 
p. 101 (statement of Dr. Wayne Callaway); see also p. 181 (statement of 
Dr. Michael Jacobson).
   ADDITIONAL VIEWS OF HON. DAVID M. McINTOSH AND HON. MARK E. SOUDER

    The Committee's report offers a candid assessment of the 
problems that plague the FDA's food approval process. With 
nearly 300 food additive petitions pending with the FDA (some 
that were filed in the 1970's), it is obvious that the system 
in place at the FDA today is not capable of meeting the current 
statutory mandate that all food additive applications be 
approved or declined within 180 days of submission. The 
Committee's recommendations are sound ones that should be well 
accepted by the food industry, consumer groups, and the FDA. 
Unfortunately, I am concerned that the enforcement mechanisms 
for the Committee's recommendations are inadequate.
    Currently, the FDA's delay in approving food additives is 
caused by inertia within the agency. While that inertia can be 
somewhat alleviated through instructions to do better, I am 
convinced that it cannot be eliminated without a significant 
enforcement hammer. I am particularly concerned that the 
recommendations include a relaxation of the statutory deadline 
for a decision on a food additive from 180 to 360 days.
    While relaxing the statutory deadline makes some sense, it 
also makes sense to transform it into a meaningful one. If the 
time frames in the Government Reform and Oversight Report were 
expected to be 360 days, then after a brief period--90 days 
perhaps--the statute should provide FDA with three options: (1) 
issue a regulation approving the use of the additive, (2) 
disapprove the use of the additive, but only if FDA can 
demonstrate that an additive has not been found to be safe, or 
(3) if FDA fails to do either, the additive is deemed to be 
approved. In this way, FDA is provided an incentive to engage 
in a real cost/benefit analysis in the allocation of its 
resources. I am convinced that unless hammers such as this one 
are incorporated into the regulatory schemes we have developed, 
we are destined to see agencies fail to meet statutory 
deadlines and justify their failures with claims of too much 
work and too few resources.
                                                 David M. McIntosh.
                                                    Mark E. Souder.

                                   - 
