to FDA Response to NRDC's FOIA Request No. 2013-8042 for GRN-1

NRDC: Safety Loophole for Chemicals in Food - Index to FDA Response to NRDC's FOIA Request No. 2013-8042 for GRN-1 (PDF)Index to U.S. Food and Drug Administration’s (FDA) Response to Natural Resources Defense Council’s (NRDC) October 11, 2013 Freedom of Information Act (FOIA) Request (FDA FOA Request No 2013- 8042) for 20 Selected Generally Recognized as Safe (GRAS) Nsotices (GRN) Submitted to the Agency between 1998 and 2013.
GRN No.1 Description FDA’s Disposition of GRN Total Pages
Page # in Main File2
October 11, 2013 9 2
FDA’s Confirmation of receipt - 1 11 FDA’s 1st Response – January 16,
2014 1 12
1 13
1 14
GRN-1 Soy isoflavone extract Nov 3, 1998 At notifier's request, FDA ceased to evaluate the notice
809 15
1 Posted at www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?rpt=grasListing. 2 See file labelled “chemicals-in-food-FOIA-Main.pdf” for information on other GRNs.
Index to FDA Response to NRDC's FOIA Request No. 2013-8042 for GRN-1 Page 1 of 885
VIA FAX AND CERTIFIED MAIL
Food and Drug Administration Division of Freedom of Information Office of Shared Services Office of Public Information and Library Services 12420 Parklawn Drive ELEM-1029 Rockville, MD 20857 FAX: (301) 827-9267 Re: FOIA Request for Records Regarding Generally Recognized as Safe Notices Received
by the Agency
Dear FOIA Officer: I write on behalf of the Natural Resources Defense Council (NRDC) to request disclosure of records pursuant to the Freedom of Information Act (“FOIA”), 5 U.S.C. § 552, and applicable Food and Drug Administration (“FDA”) regulations, 21 C.F.R. Part 20. I. Description of Records Sought
Please produce records1 in FDA’s possession, custody or control on or before September 30, 2013 associated with the Generally Recognized as Safe (GRAS) notices described in Appendix A. We are specifically seeking the following records:
(a) Communications between FDA and the individual or firm that submitted the GRAS notice to the agency as well as the additive manufacturer or their representative;
(b) Comments received from other persons outside the agency regarding the GRAS notice;
(c) Communications between FDA and the European Food Safety Authority regarding the substance or substances described in the GRAS notice; and
1 “Records” means anything denoted by the use of that word or its singular form in the text of FOIA and includes correspondence, minutes of meetings, memoranda, notes, emails, notices, facsimiles, charts, tables, presentations, orders, filings, and other writings (handwritten, typed, electronic, or otherwise produced, reproduced, or stored). This request seeks responsive records in the custody of any FDA office, including, but not limited to, FDA Headquarters offices, and specifically including FDA offices in possession of records regarding the GRAS notifications described in Appendix A.
1152 15th Street, N.W. Suite 300 NEW YORK * SAN FRANCISCO * LOS ANGELES * CHICAGO * BEIJING
www.nrdc.org Washington, D.C. 20005 TEL 202 289-6868 FAX 202 289-1060
NATURAL RESOURCES DEFENSE COUNCIL
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(d) Memo from FDA’s scientific staff describing the preliminary or final results of their evaluation of the GRAS notices exposure assessment, toxicity assessment, safety assessment, or environmental impact.
We are not seeking: (a) Copies of the notices and agency decisions FDA posted at
http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?rpt=grasListing as of October 10, 2013.
II. Request for a Fee Waiver
NRDC requests that FDA waive the fee that it would otherwise charge for search and production of the records described above. FOIA dictates that requested records be provided without charge “if disclosure of the information is in the public interest because it is likely to contribute significantly to public understanding of the operations or activities of the government and is not primarily in the commercial interest of the requester.” 5 U.S.C. § 552(a)(4)(A)(iii); see also 21 C.F.R. § 20.46. The requested disclosure would meet both of these requirements. In addition, NRDC qualifies as “a representative of the news media” entitled to a reduction of fees under FOIA. 5 U.S.C. § 552(a)(4)(A)(ii)(II).
A. NRDC Satisfies the First Fee Waiver Requirement
The disclosure requested here would be “likely to contribute significantly to public
understanding of the operations or activities of the government.” 5 U.S.C. § 552(a)(4)(A)(iii); 21 C.F.R. § 20.46(a)(1). Each of the four factors used by FDA to evaluate the first fee waiver requirement indicates that a fee waiver is appropriate for this request. See 21 C.F.R. § 20.46(b).
1. Subject of the request The records requested here were either received by the agency or generated by the agency as
it evaluated the GRAS notice. The requested records thus directly concern “the Government’s operations or activities.” 21 C.F.R. § 20.46(b).
2. Informative value of the information to be disclosed
The requested records are “likely to contribute significantly to public understanding of
operations and activities of the Government.” 21 C.F.R. § 20.46(a)(1). The public does not currently possess comprehensive information regarding the government’s role in addressing public health issues related to the potential use of the listed GRAS substances in food.
We believe that the records requested are not currently in the public domain. Their disclosure
would thus meaningfully inform public understanding with respect to food safety, as further discussed below. However, if FDA were to conclude that some of the requested records are publicly available, NRDC would like to discuss that conclusion and might agree to exclude such records from this request.
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3. Contribution to an understanding of the subject by the public is likely to result
from disclosure.
Because NRDC is a “representative of the news media,” as explained in Part II.C below,
FDA must presume that this disclosure is likely to contribute to public understanding of its subject. 21 C.F.R. § 20.45(a)(2).
However, even if NRDC were not a media requester, NRDC’s expertise in food safety,
extensive communications capabilities, and proven history of dissemination of information of public interest—including information obtained from FOIA records requests—indicate that NRDC has the ability and will to use disclosed records to reach a broad audience of interested persons with any relevant and newsworthy information the records reveal.
NRDC intends to disseminate any newsworthy information in the released records and its
analysis of such records to its member base and to the broader public, through one or more of the many communications channels referenced below. NRDC frequently disseminates newsworthy information to the public for free, and does not intend to resell the information requested here. NRDC’s more than one million members and online activists are a broad audience of persons interested in the subject of GRAS notices, and when combined with NRDC’s communications to the public at large, the likely audience of interested persons to be reached is certainly reasonably broad. As NRDC’s long history of incorporating information obtained through FOIA into reports, articles and other communications illustrates, NRDC is well prepared to convey to the public any relevant information it obtains through this records request.
NRDC has the ability to disseminate information on GRAS notices through many channels.
As of September 2013, these include, but are not limited to the following: NRDC’s website, available at http://www.nrdc.org , which is updated daily and draws
approximately 1,142,700 page views and 478,000 unique visitors per month. OnEarth magazine, which is distributed to approximately 130,000 subscribers, for sale at
newsstands and bookstores, and available free of charge at http://www.onearth.org (a site that itself has about 33,700 email subscribers and receives more than 45,600 unique visitors per month).
Nature’s Voice newsletter on current environmental issues, which is distributed five times a year to NRDC’s more than one million members and online activists, and is available online at http://www.nrdc.org/naturesvoice/default.asp.
Earth Action email list which has more than 179,000 subscribers who receive biweekly information on urgent environmental issues. This information is also made available through NRDC’s online Action Center at http://www.nrdc.org/action/default.asp.
This Green Life, which is an electronic newsletter on environmentally sustainable living. It is distributed by email to 52,000 subscribers and made available online at http://www.nrdc.org/thisgreenlife/default.asp.
NRDC Online, which is a semimonthly electronic environmental newsletter distributed by e-mail to more than 50,400 subscribers, at http://www.nrdc.org/newsletter.
“Switchboard,” available at http://switchboard.nrdc.org , which is a staff blogging site that is updated daily and features more than 130 bloggers writing about current environmental issues. The blogs draw approximately 175,00 page views and 109,200 unique visitors per month; Switchboard’s RSS feeds have approximately 7,500 subscribers; and Switchboard posts appear on websites of other major internet media outlets, such as “The Huffington Post,” at http://www.huffingtonpost.com.
NRDC issues press releases, issue papers, and reports; directs and produces movies, such as
Stories from the Gulf, narrated by Robert Redford and Acid Test, narrated by Sigourney Weaver; participates in press conferences and interviews with reporters and editorial writers; and has approximately thirty staff members dedicated to communications work, see list of select communications staff at http://www.nrdc.org/about/staff.asp.
NRDC employees provide Congressional testimony; appear on television, radio and web
broadcasts and at conferences; and contribute to numerous national newspapers, magazines, academic journals, other periodicals, and books.
NRDC routinely uses FOIA to obtain information from federal agencies that NRDC legal and scientific experts analyze in order to inform the public about a variety of issues, including energy policy, climate change, wildlife protection, nuclear weapons, pesticides, drinking water safety, and air quality. Some specific examples are provided below:
(1) In October 2008, NRDC issued a report assessing the degree of enforcement of California’s environmental and public health laws. This report, An Uneven Shield: The Record of Enforcement and Violations Under California’s Environmental, Health, and Workplace Safety Laws, examined data on known violations and law enforcement responses under six critical pollution, health, and workplace safety programs. Much of the data analyzed in the study was obtained through formal FOIA requests; some of it was synthesized from other sources. See id. at pp. 4, 16.
(2) NRDC obtained, through a court-enforced FOIA request, records of the operations of
the Bush administration’s Energy Task Force, headed by Vice President Dick Cheney. It made those records available, along with analysis of selected excerpts and links to the administration’s index of withheld documents, on NRDC’s website at http://www.nrdc.org/air/energy/taskforce/tfinx.asp. NRDC’s efforts helped to inform the public about an issue that, even before the records’ release, had attracted considerable attention. See, e.g., Elizabeth Shogren, “Bush Gets One-Two Punch on Energy,” L.A. Times, Mar. 28, 2002, at A22; Bennett Roth, “Houston Energy-Drilling Firm Appears in Documents from Energy Department,” Houston Chronicle, Apr. 12, 2002.
(3) NRDC obtained, through a FOIA request, a memorandum by ExxonMobil
advocating the replacement of a highly respected atmospheric scientist, Dr. Robert Watson, as the head of the Intergovernmental Panel on Climate Change. NRDC used this memorandum to help inform the public about what may have been behind the decision by the Bush administration to replace Dr. Watson. See NRDC Press Release and attached Exxon memorandum, “Confidential Papers Show Exxon Hand in White House Move to Oust Top Scientist from International Global Warming Panel,” Apr. 3, 2002; Elizabeth Shogren, “Charges Fly Over Science Panel Pick,” L.A. Times, Apr. 4, 2002, at A19.
(4) NRDC incorporated information obtained through FOIA into a 2005 report,
published and provided free of charge at NRDC’s website, see http://www.nrdc.org/wildlife/marine/sound/contents.asp, on the impacts of military
(5) NRDC scientists have used information obtained through FOIA to publish analyses
of the United States’ and other nations’ nuclear weapons programs. In 2004, for example, NRDC scientists incorporated information obtained through FOIA into a feature article on the United States’ plans to deploy a ballistic missile system and the implications for global security. See Hans M. Kristensen, Matthew G. McKinzie, and Robert S. Norris, “The Protection Paradox,” Bulletin of Atomic Scientists, Mar./Apr. 2004.
(6) NRDC has used White House documents obtained through FOIA and from other
sources to inform the public about EPA’s failures to protect wildlife and workers from the pesticide atrazine in the face of industry pressure to keep atrazine on the market. See http://www.nrdc.org/health/atrazine/files/atrazine10.pdf; see also William Souder, “It’s Not Easy Being Green: Are Weed-Killers Turning Frogs Into Hermaphrodites?” Harper’s Bazaar, Aug. 1, 2006 (referencing documents obtained and posted online by NRDC).
(7) NRDC has obtained, through FOIA and other sources, information on the levels of
arsenic in drinking water supplies across the country. NRDC synthesized that information into a report, Arsenic and Old Laws (2000), printed and made available online through NRDC’s website, see http://www.nrdc.org/water/drinking/arsenic/aolinx.asp, and provided analysis describing its significance and guiding interested members of the public on how to learn more about arsenic in their own drinking water supplies. Id.; see also Steve LaRue, “EPA Aims to Cut Levels of Arsenic in Well Water,” San Diego Union- Tribune, June 5, 2000, at B1 (referencing NRDC report).
(8) In 2000, NRDC used information obtained through FOIA to publish a report
analyzing the impacts of manure pollution from large livestock feedlots on human health, fish and wildlife. See NRDC, Spills & Kills, Aug. 2000.
(9) In 1999, NRDC obtained, through FOIA, a Defense Department document, History
of the Custody and Deployment of Nuclear Weapons: July 1945 through September 1977. The document attracted significant press attention once it was disclosed. See, e.g., Walter Pincus, “Study Says U.S. Secretly Placed Bombs; Cold War Deployments Affected Mostly Allies,” Washington Post (Oct. 20, 1999) at A3. One of NRDC’s nuclear scientists, Robert Norris, published a detailed analysis of this document explaining its significance to the public. See Robert S. Norris, William M. Arkin, and William Burr, “Where They Were,” Bulletin of Atomic Scientists, Nov./Dec. 1999.
(10) In 1996, NRDC obtained, through FOIA, test results regarding lead levels in the
District of Columbia’s drinking water supplies. NRDC made the test results public along with analysis explaining the significance of the results. See D’Vera Cohn, “Tap
(11) In 1989, NRDC obtained, through FOIA, testimony, previously suppressed by the
first Bush administration, by federal experts who opposed oil drilling off the coasts of California and Florida. See Larry Liebert, “Oil Testimony Reportedly Quashed; Environmentalists say Federal Experts Pressured by Bush,” Orange County Register, Oct. 5, 1989, at A6.
(12) In 1988, NRDC obtained, through FOIA, a report by the U.S. Fish and Wildlife
Service that declared that the government’s review of offshore oil drilling in Northern California was incomplete and overly optimistic. Reagan administration officials had tried to keep the report secret and then repudiated it upon its release. See Eric Lichtblau, “Federal Report Blasts Offshore Oil Studies,” L.A. Times, June 4, 1988, at A32.
(13) In 1982, NRDC obtained, through a FOIA request, an EPA memorandum stating that
most air pollution monitors have repeatedly underestimated levels of toxic lead in the air. NRDC used the memorandum to inform the public about the consequences of EPA’s proposal to relax restrictions on lead in gasoline. See Sandra Sugawara, “Lead in Air is Undermeasured, EPA Section Chief’s Memo Says,” Washington Post, July 11, 1982, at A6.2
As these examples demonstrate, NRDC has a proven ability to digest, synthesize, and quickly
disseminate information gleaned from FOIA requests to a broad audience of interested persons. Therefore, the requested records disclosure is likely to contribute to the public’s understanding of the subject.
4. Significance of the contribution to public understanding
The records requested shed light on a matter of considerable public interest and concern:
GRAS notices for additives use in food. Public understanding of food safety would be significantly enhanced by disclosure of the
requested records concerning GRAS notices. Disclosure would help the public to more effectively evaluate food safety. Disclosure would also help the public to better understand and evaluate FDA’s actions (or inaction) on GRAS notices.
B. NRDC Satisfies the Second Fee Waiver Requirement
Disclosure in this case would also satisfy the second prerequisite of a fee waiver request
because NRDC does not have any commercial interest that would be furthered by the requested disclosure. 5 U.S.C. § 552(a)(4)(A)(iii); 21 C.F.R. § 20.46(c). NRDC is a not-for-profit organization and does not act as a middleman to resell information obtained under FOIA. “Congress amended FOIA to ensure that it be ‘liberally construed in favor of waivers for noncommercial requesters.’”
2 Information NRDC obtained through FOIA requests resulted in other articles, in addition to those referenced above, see, e.g., Felicity Barringer, “Science Panel Issues Report on Exposure to Pollutant,” N.Y. Times, Jan. 11, 2005; Katharine Q. Seelye, “Draft of Air Rule is Said to Exempt Many Old Plants,” N.Y. Times, Aug. 22, 2003; Don Van Natta, Jr., “E-Mail Suggests Energy Official Encouraged Lobbyist on Policy,” N.Y. Times, Apr. 27, 2002.
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Judicial Watch, Inc. v. Rossotti, 326 F.3d 1309, 1312 (D.C. Cir. 2003) (internal citation omitted); see Natural Res. Def. Council v. United States Envtl. Prot. Agency, 581 F. Supp. 2d 491, 498 (S.D.N.Y. 2008). NRDC wishes to serve the public by reviewing, analyzing and disclosing newsworthy and presently non-public information about GRAS notices. As noted at Part II.A, any work done by FDA on GRAS notices relates to a matter of considerable public interest and concern. Disclosure of the requested records will contribute significantly to public understanding of GRAS notices and associated threats to human health and the environment.
C. NRDC Is a Media Requester
Even if FDA denies a public interest waiver of all costs and fees, NRDC is a representative of the news media entitled to a reduction of fees under FOIA, 5 U.S.C. § 552(a)(4)(A)(ii), and FDA’s FOIA regulations, 21 C.F.R. § 20.45(a)(2). See Elec. Privacy Info. Ctr. v. Dep’t of Def., 241 F. Supp. 2d 5, 6, 11-15 (D.D.C. 2003) (a “non-profit public interest organization” qualifies as a representative of the news media under FOIA where it publishes books and newsletters on issues of current interest to the public); Letter from Alexander C. Morris, FOIA Officer, United States Dep’t of Energy, to Joshua Berman, NRDC (Feb. 10, 2011) (granting NRDC media requester status).
NRDC is in part organized and operated to publish or transmit news to the public. As described earlier in this request, NRDC publishes a quarterly magazine, OnEarth, which has approximately 150,000 subscribers, is available at newsstands and bookstores, and has won numerous news media awards, including the Independent Press Award for Best Environmental Coverage and for General Excellence, a Gold Eddie Award for editorial excellence among magazines, and the Phillip D. Reed Memorial Award for Outstanding Writing on the Southern Environment. NRDC also publishes a regular newsletter for its more than one million members and online activists; issues other electronic newsletters, action alerts, public reports and analyses; and maintains free online libraries of these publications. NRDC maintains a significant additional communications presence on the internet through its staff blogging site, “Switchboard,” which is updated daily and features more than 130 bloggers writing about current environmental issues, and through daily news messaging on “Twitter” and “Facebook.” See OPEN Government Act of 2007, Pub. L. No. 110-175, § 3, 121 Stat. 2524 (2007) (codified at 5 U.S.C. § 552(a)(4)(A)(ii)) (clarifying that “as methods of news delivery evolve . . . such alternative media shall be considered to be news-media entities”). The aforementioned publications and media sources routinely include information about current events of interest to the readership and the public. To publish and transmit this news content, NRDC employs approximately thirty staff dedicated full-time to communications with the public, including accomplished journalists and editors, see list of select communications staff at http://www.nrdc.org/about/staff.asp. These staff rely on information acquired under FOIA and through other means. That NRDC is a public interest advocacy organization is inconsequential so long as “its activities qualify as those of a representative of news media,” and NRDC’s do. Elec. Privacy Info. Ctr., 241 F. Supp. 2d at 12. Public interest organizations meeting the requirements “are regularly granted news representative status.” Serv. Women’s Action Network v. Dep’t of Def., 888 F. Supp. 2d 282, 287-88 (D. Conn. 2012) (according media requester status to the American Civil Liberties Union).3
Information obtained as a result of this request will, if appropriately newsworthy, be synthesized with information from other sources and used by NRDC to create and disseminate unique articles, reports, analyses, blogs, tweets, emails, and/or other distinct informational works through one or more of NRDC’s publications or other suitable media channels. NRDC staff gather information
3 To be a representative of the news media, an organization need not exclusively perform news gathering functions. If that were required, major news and entertainment entities like the National Broadcasting Company (NBC) would not qualify as representatives of the news media. This country has a long history, dating back to its founding, of news organizations engaging in public advocacy.
from a variety of sources—including documents provided pursuant to FOIA requests—to write original articles and reports that are featured in its OnEarth magazine, newsletters, blogs, and other NRDC-operated media outlets. NRDC seeks the requested records to aid its own news-disseminating activities by obtaining, analyzing, and distributing information likely to contribute significantly to public understanding, not to resell the information to other media organizations.
III. Willingness to Pay Fees Under Protest
Please provide the records requested above irrespective of the status and outcome of your
evaluation of NRDC’s fee category status and fee waiver request. In order to prevent delay in FDA’s provision of the requested records, NRDC states that it will, if necessary and under protest, pay fees in accordance with FDA’s FOIA regulations at 21 C.F.R. § 20.45 for all or a portion of the requested records. Please consult with NRDC, however, before undertaking any action that would cause the fee to exceed $500. Such payment will not constitute any waiver of NRDC’s right to seek administrative or judicial review of any denial of its fee waiver request and/or rejection of its fee category assertion.
IV. Conclusion
We trust that, in responding to this request, FDA will comply with all relevant deadlines and
other obligations set forth in FOIA and FDA’s FOIA regulations. See, e.g., 21 C.F.R. Part 20.
Please produce the records above by emailing or mailing them to me at the NRDC office address listed below. Please produce them on a rolling basis; at no point should FDA’s search for—or deliberations concerning—certain records delay the production of others that FDA has already retrieved and elected to produce. In the event that FDA concludes that some of the records requested above may already be publicly available, we will be happy to discuss those conclusions. Please do not hesitate to call or email with questions.
Please do not hesitate to call or email with questions. I can be reached at 202-513-6252 and
[email protected].
Thank you for your prompt attention to this request.
Sincerely, Tom Neltner, Senior Attorney Natural Resources Defense Council, Inc. 1152 15th Street NW, Suite 300 Washington, DC 20005 202-513-6252 (202) 289-1060 FAX [email protected]
Appendix A: Generally Recognized as Safe (GRAS) Notices and Agency Actions
9
GENERALLY RECOGNIZED AS SAFE (GRAS) NOTICES AND AGENCY ACTIONS 1
GRN # Title
1 Soy isoflavone extract 35 Hempseed oil 36 Chromium picolinate; Ginkgo biloba leaf extract; and Ginseng extract 37 Whey protein isolate and dairy product solids 59 Hydrogenated starch hydrolysate 66 Milk thistle extract
150 Glucosamine hydrochloride prepared from chitin obtained from Aspergillus niger 224 trans-Resveratrol 225 Catechins from green tea extract 257 gamma-Amino butyric acid 262 Sweet lupin protein 263 Sweet lupin fiber 264 Sweet lupin flour 295 Aqueous extract of Emblica officinalis 322
Aqueous extract of Emblica officinalis
324 Heat-killed Lactobacillus plantarum 340 Theobromine 362 Levocarnitine 378 Cultured [dairy sources, sugars, wheat, malt, and fruit- and vegetable-based sources]
fermented by [Streptococcus thermophilus, Bacillus coagulans, Lactobacillus acidophilus, Lactobacillus paracasei subsp. paracasei, Lactobacillus plantarum, Lactobacillus sakei, Lactobacillus bulgaricus and Proprionibacterium freudenreichii subsp. shermanii or mixtures of these strains]
444 Milk protein concentrate and milk protein isolate 1 Posted at http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?rpt=grasListing.
[email protected]
In Reply Refer To: FOI 2013-8042
This is in partial response to your October 11 , 2013, request to the Food and Drug Administration (FDA) pursuant to the Freedom of Information Act for records regarding:
GRN 1,35,36 ETC
A search of the Office of the Commissioner, Office of the Executive Secretariat f iles did not reveal any responsive records to your request.
If you wish to appeal from this determination, please submit your appeal within 30 days to Director, News Division, 7700 Wisconsin Avenue, Suite 920, Bethesda, MD 20857 (by U.S. Post), or 7700 Wisconsin Avenue, Suite 920, Bethesda, MD 20814 (by private courier, such as UPS or FedEx). Please mark your envelope FDA FOIA Appeal and please include your control number.
Sincerely,
Martina H. Varnado Director Office of the Commissioner Office of the Executive Secretariat
/,...., ....... ~
(...,:/-DEPARTMENT OF HEALTH & HUMAN SERVICES
Tom Neltner Natural Resources Defense Council 1152 15th Street, N.W. Suite 300 Washington, DC 20005
Dear Mr. Neltner:
January 16, 2014
Public Health Service
Food and Drug Administration College Park, MD 20740
This is in response to your request of October 21 , 2013, requesting records related to GRAS Notices 1, 35, 36, 37, 59, 66, 150, 224, 225, 257, 262, 263, 264, 295, 322, 324, 340, 362, 378, and 444. In this response, we have provided responsive records for 19 of the 20 GRAS Notices you requested. We are compiling responsive records for GRAS Notice 1 and will provide these at a later date. Per your request, we do not include copies of the notices and agency letters posted at :http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?rpt=graslisttng in our response. We do, however, include in our response documents available in the Federal Register or Docket FDA-1997-N- 0020 to ensure completeness of the responsive records. Your request was forwarded to the Office of Food Additive Safety in the Center for Food Safety and Applied Nutrition.
_X __ Enclosed is a partial response of the records you requested (with the exception of responsive records for GRAS Notice 1 ).
_ X_ Certain material has been deleted from the records furnished to you because a preliminary review of the- records indicated that the deleted information is not required to be publicly disclosed and that disclosure is not appropriate. FDA has taken this approach to facilitate the process of responding to you. If you dispute FDA's preliminary determination with respect to these records and would like FDA to reconsider any particular deletion, please let us know in writing at the following address: Food and Drug Administration, Division of Freedom of Information, HFI-35i 5600 Fishers Lane, Rockville, MD 20857 · within 30 days from the date of this letter. If we do not receive a response in that time period, we will consider the matter closed with respect to these records. If you do request further consideration and if the agency then formally denies your request for any or all of the previously-withheld information, you will have the right to appeal that decision Any letter of denial will explain how to make this appeal.
The following charges for this request to date may be included in a monthly invoice:
Reproduction$ 0.00 Search $0.00 Review m,QQ.Other $0.00 CCD> Total $0.00
THE ABOVE TOTAL MAY NOT REFLECT THE FINAL CHARGES FOR THIS REQUEST PLEASE DO NOT SEND PAYMENT UNTIL YOU RECEIVE AN INVOICE FOR THE TOTAL MONTHLY FEE.
Enclosure
Sincerely Yours,
Sharon ll Dodson S =---:--_:--=-=... -- ·- Sharon R Dodson Program Analyst Office of Food Additive Safety Center for Food Safety and Applied Nutrition
$ ,. ... -_,,"l.t . ~ ( 4-DEPARTMENT OF HEALTH & HUMAN SERVICES
<:j
Dear Mr. Neltner:
March 19, 2014
This completes our response to your request of October 21, 2013, requesting records related to GRAS Notices 1, 35, 36, 37, 59, 66, 150, 224, 225, 257, 262, 263, 264, 295, 322, 324, 340, 362, 378, and 444. Per your request, we do not include copies of the notice and agency letter posted at http:/lwww.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?rot=graslisting in our response. We do, however, include in our response documents available in Docket FDA-1997-N-0020 to ensure completeness of the responsive records Your request was forwarded to the Office of Food Additive Safety in the Center for Food Safety and Applied Nutrition.
In this response, we provide Part 1 of 2 of the responsive records for GRAS Notice 1, thus completing our response for this notice.
X Enclosed is Part 1-GRAS Notice 1 of the records you requested.
_x_ Certain material has been deleted from the records furnished to you because a preliminary review of the records indicated that the deleted information is not required to be publicly disclosed and that disclosure is not appropriate. FDA has taken this approach to facilitate the process of responding to you. If you dispute FDA's preliminary determination with respect to these records and would like FDA to reconsider any particular deletion, please let us know in writing at the following address: Food and Drug Administration, Division of Freedom of Information, HFI-35, 5600 Fishers Lane, Rockville, MD 20857 within 30 days from the date of this letter. If we do not receive a response in that time period, we will consider the matter closed with respect to these records. If you do request further consideration and if the agency then formally denies your request for any or all of the previously-withheld information, you will have the right to appeal that decision. Any letter of denial will explain how to make this appeal.
The following charges for this request to date may be included in a monthly invoice:
Reproduction $ 0.00 Search ~ Review $0.00 Other $0.00 (CO) Total $0.00
THE ABOVE TOTAL MAY NOT REFLECT THE FINAL CHARGES FOR THIS REQUEST. PLEASE DO NOT SEND PAYMENT UNTIL YOU RECEIVE AN INVOICE FOR THE TOTAL MONTHLY FEE.
Enclosure
Sincerely Yours, Sharon R. Dodson :::-:..~-::::::::.."::.-
=:=~-.. ,,.,_..._ ... s -·-~~~~·-- Sharon R. Dodson Program Analyst Office of Food Additive Safety Center for Food Safety and Applied Nutrition
~..-a\lf"ll· .. ~ ( ..11 DEPARTMENT OF HEALTH & HUMAN SERVICES
~~ .. ~'!- 1 .. .. .,)(1~
Dear Mr. Neltner:
March 19, 2014
This completes our response to your request of October 21 , 2013, requesting records related to GRAS Notices 1, 35, 36, 37, 59, 66, 150, 224, 225, 257, 262, 263, 264,295, 322, 324, 340, 362, 378, and 444. Per your request, we do not include copies of the notice and agency letter posted at http://WWW_accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?rpt=grasllsting in our response. We do, however, include in our response documents available in Docket FDA-1997-N-0020 to ensure completeness of the responsive records Your request was forwarded to the Office of Food Additive Safety In the Center for Food Safety and Applied Nutrition.
In this response, we provide Part 2 of 2 of the responsive records for GRAS Notice 1, thus completing our response for this notice.
_x_ Enclosed is Part 1-GRAS Notice 1 of the records you requested.
_X_ Certain material has been deleted from the records furnished to you because a preliminary review of the records indicated that the deleted information is not required to be publicly disclosed and that disclosure Is not appropriate. FDA has taken this approach to facilitate the process of responding to you. If you dispute FDA's preliminary determination with respect to these records and would like FDA to reconsider any particular deletion, please let us know in writing at the following address: Food and Drug Administration, Division of Freedom of Information, HFI-35, 5600 Fishers Lane, Rockville, MD 20857 within 30 days from the date of this letter. If we do not receive a response in that time period, we will consider the matter closed with respect to these records. If you do request further consideration and if the agency then formally denies your request for any or all of the previously-withheld information, you will have the right to appeal that decision. Any letter of denial will explain how to make this appeal.
The following charges for this request to date may be included in a monthly Invoice:
Reproduction l.Q..QQ Search m.QQ Review $0.00 Other $0.00 (CO) Total $0.00
THE ABOVE TOTAL MAY NOT REFLECT THE FINAL CHARGES FOR THIS REQUEST. PLEASE DO NOT SEND PAYMENT UNTIL YOU RECEIVE AN INVOICE FOR THE TOTAL MONTHLY FEE.
Enclosure
Sincerely Yours,
Shiron R. =~-:~-::::: .. Dodson ·S ~~=.. ... Sharon R. Dodson Program Analyst Office of Food Additive Safety Center for Food Safety and Applied Nutrition
FD I1111111 11111 111 1111 - DEPARTMENT OF HEALTH AND HUMAN SERVICES
March 5, 1998
Mr. Mark W. Empie Director, Regulatory Mairs Archer Daniels Midland Company Box 1470 Decatur, IL 62525
Re: GRAS Notice No. GRN 00000 1
Dear Mr. Empie:
This letter acknowledges receipt on February 10, 1998, of your notice dated February 4, 1998. This notice was submitted to the Food and Drug Administration in accordance with the agency's proposed regulation (proposed 21 CFR 170.36; Federal Register of April 17, 1997; 62 FR 18938) regarding a notice of a claim for exemption from the statutory premarket approval requirements based on a GRAS (i.e., generally recognized as safe) determination. In your notice, you state that you have determined that soy isoflavone extract is GRAS for use as a micronutrient in foods such as performance bars, mature adult meal replacements, and certain beverages (which you characterize as "healthy") at a level of 25 mg soy isoflavone extract per serving. The soy isoflavone extract contains a mixture of the aglycone base isoflavone molecules genistein (CAS Reg. No. 446-72-0), daidzein (CAS Reg. No. 486-66-8) and glycitein (CAS Reg. No. 40957-83-3) and their glycone deriviatives genistin (CAS Reg. No. 529-59-9), daidzin (CAS Reg. No. 552-66-9) and glycitin (CAS Reg. No. 40246-10-4), respectively.
This notice has been designated GRAS Notice No. GRN 000001. In accordance with proposed 0 170.36(f), a copy of your cover letter, which includes the information described in proposed 0 170.36(~)(1), is available for public review and copying at the agency's Dockets Management Branch (Docket No. 98s-0103). If you have any questions about your notice, please feel free to call me at (202)4 18-3 10 1.
Sincerely yours,
Linda Kahl, Ph.D. Regulatory Policy Branch, HFS-206 Division of Product Policy Center for Food Safety
and Applied Nutrition (b) (5)
(b) (5)
TO : From : Certify:
[email protected] Linda Kahl@[email protected] N
FD I1111111 11111 111 1111 Subject: Soy Isoflavones Date: Tuesday, March 2 4 , 1998 at 9:43:23 am EST
, Attached: None *%
March 24 , 1998
Ms. Yvonne Clapperton Soy Information Service P.O. Box 3285 Onerahi Whangarei, New Zealand
Dear Ms. Clapperton:
This is in response to your electronic mail message, dated March 1 8 , 1998 , to the Director of the Center for Food Safety and Applied Nutrition (CFSAN), U.S. Food and Drug Administration (FDA), regarding a report in the publication Food Chemical News that Archer Daniels Midland Company (ADM) had determined that soy isoflavone is generally recognized as safe (GRAS) for use as a micronutrient in food. In your electronic mail message, you ask that we advise you of the appropriate mechanism whereby you can lloppose the petition" of ADM.
Under section 2 0 1 ( s ) of the Federal Food, Drug, and Cosmetic Act (the Act), 3 food ingredient is not subject to premarket approval if the ingredient is generally recognized, among experts qualified by training and experience to evaluate its safety, as having been adequately shown to be safe under the conditions of its intended use. In the Federal Register of April 1 7 , 1997, FDA published a proposed rule that would establish a notification procedure whereby any person may notify FDA of a determination that a particular use of a substance is not subject to the premarket approval requirements of the Act because such use is GRAS. Under the proposed notification procedure, FDA would evaluate whether the submitted notice provides a sufficient basis for a GRAS determination and whether information in the notice or otherwise available to FDA raises issues that lead the agency to question whether use of the substance is GRAS. procedure would be a letter from FDA to the notifier.
The endpoint of the proposed notification
.Although that proposed rule has not become final, FDA invited interested parties to participate in the notification procedure during the interim between the proposed and final rules. notice to FDA that ADM has determined that the use of soy isoflavones as a micronutrient in food is GRAS. whether it provides a sufficient basis for ADM's GRAS determination. FDA welcomes fact-based information on food safety issues. Accordingly, you ray submit such information to the Office of Premarket Approval (HFS-200),
The subject ADM submission is a
FDA is evaluating ADMIs notice to determine
000152 Mar 24, 1998 Index to FDA Response to NRDC's FOIA Request No. 2013-8042 for GRN-1 Page 16 of 885
Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C Street SW, Washington, DC 20204 and request that it be considered with respect to GRAS Notice Number GRN 000001.
The April 17, 1997, proposed rule is available electronically on CFSAN's home page at http://vm.cfsan.fda.gov, within the section regarding Food Additives and Premarket Approval, Documents for Industry. If you have any further questions, I am the official contact person for the GRAS notification program. I am in the office Monday through Friday from 7:15
a.m. to 3:45 p.m. (U.S. Eastern Time).
Linda S. Kahl, Ph.D. Regulatory Policy Branch, HFS-206 Office of Premarket Approval Center for Food Safety and Applied Nutrition 200 C St., SW, Washington DC 20204 Phone: (202)418-3101 Fax: (202)418-3131 Internet:[email protected]
i.
000153
Page 1 of 3 FACSIMILE FD I1111111 11111 Ill Ill1
Office of Prernarket Approval Center for Food Safety & Appfied Nutrition
Food and Drug Administration 200 C Street, S.W. ( H F S - a c )
Washington, D.C. 20204
0 00 167
TO : From :
Certify : N Sub j ect : Response to telefaxes
None R Date: Friday, March 27, 1998 at 1:34:49 pm EST
'io : zy . Xchard F. James c/o Dr. Yvonne Clapperton
This is in response to your telefaxes dated 3/25/98 and 3/26/98. no prescribed format for a submission that would oppose a GRAS notice; therefore, my only advice is that any information you submit bear on the safety of the whether soy isoflavone extract would be generally recognized as safe under its conditions of intended use - i.e., for use as a micronutrient in foods such as performance bars, mature adult meal replacements, and certain beverages at a level of 25 mg soy isoflavone extract per serving. GRN # O O O O O l does not relate to the use of soy isoflavones in food products such as infant formula or baby foods.
We have
I do, however, recommend that any submission of published articles be supported by your explanation of how each cited article bears on your conclusion regarding whether the subject use of soy isoflavones is GRAS.
Linda S . Kahl, Ph.9, Kegulatory Policy Branch, HFS-206 9ffice of Premarket Approval Center f o r Food Safety and Applied Nutrition 200 C St., SW, Washington DC 20204 Phone: (202)418-3101 Fax: (202)418-3131 Internet : LKAHLkZBANGATE. FDA. GOV
000166
Apr 23, 1 9 9 8 Index to FDA Response to NRDC's FOIA Request No. 2013-8042 for GRN-1 Page 19 of 885
DEPARTMENT OF HEALTH AND HUMAN SERVICES FD I1111111 Ill11 111 1111 . G
c
c
Between: LiidaKahl, Ph.D. (HFS-206)
..--
and
Gary Yingling, McKenna and Cuneo (202)496-7645 (on behalf of Archer Daniels Midland Company (ADM))
and Mark Empie, ADM ..
Subject: G R ” o 000001; Soy Isoflavones
On March 3 1, 1998, I telephoned Mr. Yingling and asked whether ADM would be willing to supply an electronic copy of their notice. I made this request so that the electronic copy could be used to respond electronically to Freedom of Information POI) requests for copies of the notice. Mr. Yingling contacted Mark Empie of ADM, who arranged for the delivey of the electronic copy. Mr. Empie asked for time to venfy that their electronic copy was identical to the hard copy that had been printed for delivery to the agency in the GRAS notice. I received the electronic copy from Mark Matlock of ADM on April 9, 1998, via electronic mail.
On May 6, 1998, I telephoned Mr. Yingling and asked that ADM identify more specifically the food categories that ADM considered to be within the scope of its GRAS determination. I made this request because the notice described the intended food categories as “example use foods,” which was inadequate from the perspective of evaluating dietary exposure to soy isoflavones. On May 18, 1998, I received a call from Mark Empie of ADM, who stated that the three ”example use foods” listed on p. 24 of the notice (mature adult meal replacements, healthy drinks, and performance bars) were the only food categories that ADM was considering in its GRAS notice for the use of soy isoflavones.
On May 13, 1998, I telephoned Mr. Yingling and informed him that our review scientists had experienced difficulties in finding some references listed in the ADM submission. As examples, we were unable to locate Reference #12 and #40 and we noted that Reference #40a did not include any page numbers. Mr. Yingling called me back for a conference call with Mark Empie of ADM. Mr Empie suggested that ADM send a copy of its references to Mr. Yingling’s office so that any references that we might need would be available for inspection.
000835
(b) (5)
G
C
c
Page 2 - Memorandum of Telephone Conference
On July 9, I received a telephone call fiom Mr. Yinghg informing me that he had, in response to a FOIA request, received information that had been incorporated into GRN No. 000001 at the request of other parties. Mr. Yinghg also asked whether, while the GRAS notice is pending, it would be possible for ADM to submit to the Office of Special Nutritionals a notice for the use of soy isoflavones as a dietary ingredient of a dietary supplement. I responded that any use of soy isoflavones as a dietary ingredient of a dietary supplement was independent of its use in conventional food and that simultaneous notices could be pending at the agency for both uses.
On September 10, 1998, following a September 9, 1998, meeting between FDA and representatives of ADh4, Mr. Yingliing and I discussed mechanisms whereby ADM could request that FDA stop its evaluation of the current notice while ADM prepared a submission that would respond to questions raised by outside parties who had submitted information to the GRNNo 000001 file. Such a request from ADM would not preclude ADM from subsequently submitting a new notice for the use of soy isoflavones ifthey chose to do so.
Linda S. Kahl, Ph.D.
(b) (5)
TO : From :
smtp[[email protected] Linda Kahl@[email protected] I I111111 lllll Ill Ill1
Certify : N Subject: How to comment on rulemaking (GRN #1 is not rulemaking)
Attached: None 111 Date: Tuesday, March 31, i998 at 11:14:55 am EST
Dr. Hichard James c/o Dr. Yvonne Clapperton
This is in response to your request to be informed about GRN 00001, and in particular your reference to information on how to comment on proposed regulations.
The GRAS notice received from Archer Daniels Midland Co. (ADM) is not a proposed rule. Rather, it is notice informing FDA of ADM's view that the use of soy isoflavones as a micronutrient in food is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act because A D M has determined that such use is generally recognized as safe. Under FDA's proposed GRAS notification procedure (which was open to public comment for the 90 day period from April 17, 1997 to July 1 6 , 19971, FDA will evaluate ADM's submission and determice whether information in the notice or otherwise available to FDA ralses cuestions that lead the agency to question GRAS status. FDA is still q-cnq through that review process Under the terms of t h e proposed rule, FDA wou;d responit ,n writing to th- notifier within 90 days. However, until that proposed rule becomes final, FDA is not bound by the 90 day time frame and, considering that this is the first notice that we received, I would not be surprised if our response took longer than 90 days. Importantly, a response letter from FDA that did not question GRAS status would not result in a regulation because the absence of a challenge from FDA would not be equivalent to an agency affirmation of ADM's GRAS determination. I realize that the April 17, 1997 proposed rule is lengthy; the section entitled "Agency Response" (pp. 18950-18951) may be helpful.
It is important to understand the distinction between FDA's proposed rule to establish a GRAS notification procedure (which is "rulemaking" as referenced in your telefax) and the A D M notice (which is not rulemaking). Thus, although FDA welcomes factual-based evidence relating to food safety issues, any submission that you would make would be "information otherwise available to FDA" but would not be a "comment" within the meaning of notice-and-comment rulemaking.
I hope that this answers several of your questions.
Linda S. Kahl, Ph.D. n.,z%xjiilatory Policy Branch, HFS - 206
ffice of Premarket Approval
Apr 23, 1998 Index to FDA Response to NRDC's FOIA Request No. 2013-8042 for GRN-1 Page 22 of 885
TO : ISMTP@FDA-OC-TRAINING~FDAOC[<e.~~~zpatr~c~~~xtra.co.nz>] From : Linda Kahl@[email protected] Certify : N Subject : re: Re: GRAS ana soy isoflavones Date: * Attached: Tuesday, April 7 , 1998 at 8:04:45 am EDT
None
Under seccions 2 0 : ; s ) and 409 of the i-ederal Food, Drug, and Cosmetic Act (the AcL), a food ingredient is not subject to premarket tipproval if the ingredient is generally recognized, among experts qualified by training and experience to evaluate its safety, as having beeE adequately shown to be safe under the conditions of its intended use - i.e., to be GRAS. Under these provisions of the act, there is no requirement that a person who determines that a use of a substance is G U S inform FDA of that determination or obtain FDA's concurrence.
Under the act, a substance may be GRAS through scientific procedures or, for substances used in food before passage of the 1958 Food Additives Amendment, through experience based on common use in food before January 1, 1958. Shortly after the 1958 amendment, FDA assembled a partial list of substances that were known to be commonly used in food prior to 1958. This was the first G U S list and is now in Part 182 of our regulations. In the 1 9 7 0 ' s , FDA began a scientific safEty review of all substances on this llhistory of use" GRAS list. If, foll:-,wlng completion of its' review of 2
the agency deleted the listing in Part 182 and added a new listing in Part
establish the procedures that the agency would use to conduct this review. Biecaus'e not all substances used in food on the basis of the GRAS exemption were on the agency's GRAS list, FDA also established a voluntary process, the GRAS petition process, whereby persons who had made their own GRAS determination could request that FDA affirm that determination and list the affirmed use in Part 184. That procedure involved "notice and comment rulemaking," in which FDA conducts a pre-filing review to see if the petition meets certain format requirements, publishes a filing notice in the Federal Register, and in that filing notice requests comment on the proposed use. If FDA affirms the proposed use as GRAS, the agency publishes a final rule in the Federal Register and includes in that document a discussion of comments received.
' __ ~ . _ . . .~ ,I,o, particular-.sub,stance; . .F.DA *atf.f-imned that kbe ~~uSe~a5 Ene substance i-S "GRAS * t ., .
0 1 8 4 - for "affirmed GRAS" substances. FDA went through rulemaking to
In the Federal Register of April 17, 1997, FDA published a proposed rule that would eliminate the voluntary GRAS petition process. In its place, FDA proposed to establish a voluntary notification procedure whereby any person may notify FDA of a GRAS determination. In so doing, FDA stated.that a goal of this process was to increase the agency's knowledge of substances that are being added to food based on the GRAS exemption.
000221 the proposed notification procedure, FDA would not affirm the
otifier's GRAS determination and therefore FDA would not itself "classify"
the use of the substance as GRAS. The procedure does not involve notice-and-comment rulemaking because che ezdpoint of the proposed notification procedure is not a regulaLion. Instead, the endpoint would be a letter from FDA to the notifier. This lezter could identify .a. problem with the notifier's GRAS determination; however, a letter that does not
statement that FDA agreed with the notifier. @ identify a problem with the notice would noL provide an affirmative
Although that proposed rule has not become final, FDA invited interested parties to participate in the notification procedure during the interim between the proposed and final rules. The subject Archer Daniels Midland ( A D M ) submission is a notice to FDA thaE A D M has determined that the use of soy is'oflavones as a micronutrient in food is GRAS. FDA is evaluating ADM's notice to determine whether it provides a sufficient basis f o r ADM's GRAS, determination. Because the procedure does not involve rulemaking, there is no formal mechanism for submission of lfcommentsl' within the meaning of "notice and comment rulemaking." Nonetheless, FDA welcomes fact-based information on food safety issues. Accordingly, you may submit such information to the Office of Premarket Approval (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C Street SW, Washington, DC 20204 and request that it be considered with re.spect to GRAS Notice Number GRN 000001.
The April 17, 1997, proposed rule is available electroni-ally cm CFSAN's , h'ome *p.ag;e. -at http: //vm. cfsan. f da. gov, withih ,+he-.-seetion reg&-rdlny ,,roGd Additives and Premarket Approval, Documents for Industry. Please note that
@,the proposal to establish the notification procedure is in fact notice and comment rulemaking; the comment period closed on July 16, 1997. However, GRAS notices sent to the agency under the auspices of the proprosed program are NOT notice-and-comment rulemaking.
Linda S. Kahl, Ph.D. Regulatory Policy Branch, HFS-206 Office of Premarket Approval Center for Food Safety and Applied Nutrition 2 ,OO C St. , SW, Washington DC 20204 Phone: (202)418-3101 Fax: (202)418-3131 Internet:[email protected]
Page I o f a FACSIMILE I1111111 11111 111 1111 Office of Prernarket Approval
Center for Food Safety B Appiied Nutrition Food and Drug Administration
200 C Street, S.W. (HFS- & L ) Washington, D.C. 20204
M E S S A G E
000223
Dear Mr. James: This is in response to your telefax dated April 5, 1998, in which you attached a copy of a 1979 FASEB report prepared under contract to FDA. This report is not part of the current GRAS affirmation petition process. Rather, it was part of a comprehensive, agency-initiated review of the safety of GRAS substances. I have copied the following excerpt from our April 17, 1997 proposed rule because it is a fairly concise description of the GRAS affirmation process, which can be on the agency’s own initiative (which in most cases was done under the contract with FASEB) or on the petition of an interested party (the GRAS petition process).
From the April 17, 1997 proposed rule:
nonnutritive sweeteners, from the GRAS list because they were implicated in the formation of bladder tumors in rats. In response to the concerns raised by the new information on cyclamates, then-President Nixon directed FDA to re-examine the safety of GRAS substances, and FDA announced that the agency was conducting a comprehensive study of substances presumed to be GRAS (35 FR 18623; December 8, 1970). The purpose of the study was to evaluate, by contemporary standards, the available safety information regarding substances presumed to be GRAS and to promulgate each item in a new (i.e., affirmed) GRAS list, a food additive regulation, or an interim food additive regulation pending completion of additional studies.
proposed criteria that could be used to establish whether these substances should be listed as GRAS, become the subject of a food additive regulation, or be listed in an interim food additive regulation pending completion of additional studies (35 FR 18623). These criteria were incorporated into the agency’s regulations as tj 121.3 (precursor of current 0 170.30) (36 FR 12093; June 25, 1971).
FDA made a second announcement that it was conducting a study of presumed GRAS substances (36 FR 20546; October 23, 1971) and subsequently instituted a rulemaking to establish procedures that the agency could use, on its own initiative, to affirm the GRAS status of substances that were the subject of that review and were found to satisfy the criteria established in 9 121.3 (proposed rule, 37 FR 6207, March 25, 1972; final rule, 37 FR 25705, December 2, 1972). These procedures were subsequently codified at 0 170.35(a) and (b). Because the GRAS review did not cover all GRAS substances (e.g., it did not cover many substances that were marketed based on a manufacturer’s independent GRAS determination), that rulemaking included a mechanism (the current GRAS petition process; 0 170.35(c)) whereby an individual could petition FDA to review the GRAS status of substances not being considered as part of the agency’s GRAS review.
GRAS status and food additive status, and the procedures being used to conduct the current review of food substances (39 FR 34194; September 23, 1974). The final regulations based on this proposal amended 9 121.3 (current 9 170.30) to distinguish a determination of GRAS status through scientific procedures (scientific procedures GRAS determination; current tj 170.30(b)) from a determination of GRAS status through experience based on common use in food (common use GRAS determination; current 0 170.30(c)) (41 FR 53600; December 7, 1976). Those final regulations also established definitions for “common use in food” (current 9 170.3(f)) and “scientific procedures” (current 3 170.3(h)). FDA subsequently added criteria (3 170.30(~)(2)) for the determination of GRAS status through experience based on common use in food when that use occurred exclusively or primarily outside of the United States (53 FR 16544; May 10, 1988).
In 1969 (34 FR 17063; October 21, 1969), FDA deleted various cyclamate salts, a family of
In the notice announcing the comprehensive agency review of presumed GRAS substances, FDA
In 1974, the agency proposed to clarify the criteria for GRAS status, the differences between
e”‘ I hope that this answers your question.
000224 Index to FDA Response to NRDC's FOIA Request No. 2013-8042 for GRN-1 Page 26 of 885
TO : smtp[[email protected] From : Linda Kahl@[email protected] Certify: N Subject: Response to telefax of April 5 Date: Tuesday, April 7, 1998 at 9:04:15 am EDT
'**- Attached: None
'i'he followkg wa:: :axed to 64-9-434-0567 at approximaLeiy 9 : O O am Eastern Daylight Ti-e on Tuesday, April 7.
Dear Mr. James: This is in response to your telefax dated April 5, 1998, in which you attached a copy of a 1979 FASEB report prepared under contract to FDA. This report is n3t part of the current GRAS affirmation petition process. Rather, it was part of a comprehensive, agency-initiated review of the safety of GWS substances. I have copied the following excerpt from our April 17, 1997 proposed rule because it is a fairly concise description of the GRAS affirmation process, which can be on the agency's own initiative (which in most cases was done under the contract with FASEB) or on the petition of an interested party (the GRAS petition process).
From the April 17, 1997 proposed rule:
cyclamate salts, a family of nonnutritive sweeteners. from the. GRAS lis+ because they were impi.ic:&f.;eii In the formation of Siadder ~umors Fr? rats. In response to the concerns raised by the new information on cyclamates, then-President Nixon directed FDA to re-examine the safety of GRAS substances, and FDA announced that the agency was conducting a comprehensive study of substances presumed to be GRAS (35 FR 18623; December 8, 1970). The purpose of the study was to evaluate, by contemporary standards, the available safety information regarding substances presumed to be GRAS and to promulgate each item in a new (i.e., affirmed) GRAS list, a food additive regulation, or an interim food additive regulation pending completion of additional studies.
In the notice announcing the comprehensive agency review of presumed GRAS substances, FDA proposed criteria that could be used to establish whether these substances should be listed as GRAS, become the subject of a food additive regulation, or be listed in an interim food additive regulation pending completion of additional studies (35 FR 18623) These criteria were incorporated into the agency's regulations as § 121.3 (precursor of current § 170.30) (36 FR 12093; June 25, 1971).
presumed GRAS substances (36 FR 20546; October 23, 1971) and subsequently instituted a rulemaking to establish procedures that the agency could use, on its own initiative, to affirm the GRAS status of substances that were the subject of that review and were found to satisfy the criteria established in § 121.3 (proposed rule, 37 FR 6207, March 25, 1972; final rule, 37 FR 25705, December 2, 1972). These procedures were subsequently codified at § 170.35 (a) and (b) . Because the GRAS review did not cover all
In 1969 (34 FR 17063; October 21, 1969), FDA deleted various
FDA made a second announcement that it was conducting a study of
000225
GKAS substances (e.g., it did not cover many substances that were marketed based on a manufacturer's independent GRAS determinacion), that rulemaking ixcluded a mechanism (the current GRAS peticion process; 5 170.35(c)) wnereby an individuai could petition FDA to review the G?&S status of substances not being considered as part of the agency's GRAS review.
In 1974, the agency proposed to clarify the criteria for GRAS scatus, the differences between G R 4 S status and food additive st.atus, 3rd. the procedures being used to condtlzt Lhe current review cf food substances ( 3 9 FR 34194; September 23, 1 9 7 4 ) . The finai regulations based on this proposal amended § 121.3 (current § 170.30) to distinguish a determination of GRAS status through scientific procedures (scientific procedures GRAS determination; current § 170.30(b)) from a determination of GRAS status through experience based on common use in food (common use GRAS determination; current § 170.30(c)) (41 FR 53600; December 7, 1976). Those final regulations also established definitions for "common use in food" (current § 170.3 (f) ) and "scientific procedures" (current § 170 -3 (h) 1 . FDA subsequently added criteria ( § 170.30(~)(2)) for the determination of GRAS status through experience based on common use in food when that use occurred exclusively or primarily outside of the United States (53 FR 16544; May 10, 1988).
I hope that this answers your questim.
000226
04-09-98 1 1 107AM FROM FDA/CFSAN/OPA/DHEE TO 4183131 POO1/006
'\
FD I lllllll lllll Ill 1111 FOOD AND DRUG ADMINISTRATION
CENTER FOR FOOD SAFETY AND APPLIED NUTRITION
OFFICE OF PLANT AND DAIRY FOODS AND BEVERAGES
CONTAMINANTS STANDARDS MONlTORlNG AND PROGRAMS BRANCH
200 "C" ST. S.W. WASHINGTON, D.C. - 20204 FAX 2021260-0498
PHONE NO. 202/205- f i 3 f
FACSIMILE COVER SHEET
COMPANY: PHONE NO: FAX NO: TOTAL NO. OF PAGES, INCLUDING PAGE: & REMARKS: 4i
TBIS Corm- AND ?XOTJX3XD .POW DlSCUKllIU UWDLP IVIIlcMU IAW. IP YOU IRE NOT THE UJIIRESSEL OR A PERSON .IlTHORIZED TO DELIVER THE DOCVhlPNT TO THE ADDRESSEE, YOU M E HEREBY NOTIFIED TK4T N.Y REMEW, DISCLOSURE, DISSEMINATION, COPYING OR OTHER ACTION BASED ON THE CONTENT OF THIS COMMUNICATION IS NOT AUWORIZED. IF YOU HAvE WCEIMD THIS DOCUMENT IN ERROR. P L W E SOTIIIY US UIMLDIATGLY BY TELEPHONE AN0 RETURN IT TO US AT THE MOVE ADDRTSS BY MAIL
Is mu) ONLY FOR TUE USX OPTIJX PARI7 TO M O M IT IS u)L)YYXSED AND MAY CONTAIN ~ I U U T I O N ?TIAT IS ?llNllZCm,
THANK YOU fb002S3
M E M O R A N D U M
Date; October 17,19%
From: Daniel M. Sheehan, Ph.D. Reproductive & Developmental Toxicology, HFT- 130
Subject: Soy Infant Fomuta
To: Beth Yetley, M.D., Director, Office of Special Nutritionals, CFSAN
Through: John F. Young, Ph.D., Director, DRDT, &mad A. Schwetz, D.V.M., PLD., Director,
I have just arrived back from an international meeting on soy, including a satellite symposium on soy and infant health. New data presented at the meeting have increased my level of concern regarding the phytoestrogen (isoflavone) content of infant formula In particular, Ken SetchelJ, one of the two best clinical and analytical chemists in this area, showed that serum cancentrations of isoflavones in inf'mts consuming soy Went formula excadcd 20 pM. Even with a low estrogenic potency, estrogen receptmx will be occupied and estrogenic responses are predicted. Ken explicitly stated tbat this infaat serum level will lead to biological responses, but it is unclear whether these would be harmful or beneficid.
It is my opinion that such a high exposure level to estrogens during early buman postnatal development is supraphysiological and, therefore, of concern. By comparison, infant exposure levels to phytoestrogens in milk of mothers consuming soy is greatly lower than b m soy formula, so the Asian experience cannot be used for comparison. While it is possible that beneficial effecrs may be conferred by the soy infant fornula estrogens, no human evidence exists to my knowledge. Likewise, as you know, there is so little clinical evidence relating estrogen exposures to human infants with premature breast development and vaginal bleeding. Benefits and risks may also coexist in the same individual at the same doses as they do for a number of human estrogen exposures. Knowledge of benefits and risks is important for intiinned decisions across varying circumstances ranging fiom convenience to necessity.
Since neither benefits nor risks have been well-defined, and exposure exceeds physiological levels, I believe we are allowing a huge human exposure with no monitoring for health effects, when bioIogical responses are virtually certain. The 8 0 0 2 5 4 situation wamrnts a close examination; if we f i l to take any action. and significant adverse health effkcts are subsequently reported, the FDA will be blamed for not responding to an anticipated problem. (b) (5)
04-09-98 1 1 :07AM FROM FDA/CFSAN/OPA/DHEE TO 4183131 POO3/006 p 4 10/28/96 16:26 NCTR, JEFFERSON! FIRKClNSFlS 72079 + 62022055295 N0.247 PE182/8
# . . L
r U
I suggest that wc at the FDA develop a strategy for dealing with this cxposurc as soon as possible. Additionally, based on what I now how, I can no longer be a signatory to the memo we drafted about eightecn months ago, as it does not reflect our current knodtdge.
‘llhank you for your attention to this matter.
Daniel M. Sheehan, Ph.D.
cc: Janice Oliver, Deputy D k t o r for Systems and Support, CFSAN
000255
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Isoflavone Content of Breast Milk and Soy Formulas: Benefits and Risks
To the Editor: A recent editorial [I J properly cred- ited Franke and Custer [21 for an important study of urinary and breast milk concentrations of isoflavones in women consuming soy- beans. This editorial cited literature concerning potential health benefits of phytoestrogens and, to a much lesser extent, potentia1 toxidty. In the accompanying letter below, Franke points out that infants consuming soy-based formuIa are exposed to high concentrations of phytoestrogens.
Estrogens are two-edged swords in humans; both risks and benefits can be demonstrated in the same person. Two examples are oral contraceptives (benefit: fertility control; risk increased incidence of breast cancer f31) and unopposed estrogen replacement therapy (benefit: reduction in mortality due to heart disease and osteoporosis and relief of meno- pause symptoms; risk: increased incidence of endometrial cancer 14 ]). Given this characteristic of estrogens generally, what do we know of risks from phytoestrogens?
Adverse effects of phytoestrogens on reproduction and development in wildlife [SI, livestock 16 I, and exper- imental animals 171 have been docu- mented. Developmental exposure to phytoestrogens results in toxicities similar or identical to those of other estrogens. Neonatal rodents have long been used as a model of human prenatal diethylstilbestrol (DES) exposure on the basis of developmental staging and similar outcomes horn exposure IS] . However, the neonatal rodent and postnatal human are not at equivalent morphoiogical stages of development (9 J and the neonatal rodent does not model the infant human. In addition to lacking a rodent estrogen model of the human infant, we also have little clinical experience with human infant exposure to estrogens generally. Although the data are limited for developmental effects of phytoestrogens, the similarity of DES and
phytoestrogen effects in newborn rodents should be considered a cautionary note for the developmen- tally later exposure that occurs with soy infant formula. As the editorial points out, the beneficial effects of soy-based formulas or of milk from mothers consuming phytoestrogens is speculative. The same is true for potential risks.
Phytoestrogen exposure is quite high; -20% of American infants receive an isoflavonoid dose from soy formula (expressed as mg/kg) that is about five times higher than the dose that lengthened the follicular phase of the menstrual cycle and lowered lutropin and follitropin concentta- tions in adult women [ l o ] . To my knowledge, only one study is under- way in soy formula-exposed infants, despite our great uncertainty concerning benefits and risks of isoflavone exposure.
While metabolism and disposition data are important in both animals and humans, another crucial need is to define appropriate animal models and to explore phytoestrogen effects in these models; to characterize biological effects of phytoestrogens in infants, particularly those consuming soy-based infant formulas; and to be able to compare results across animals and humans. These studies need to define effects as either beneficial or adverse, and to explore a large variety of effects. They should also consider dose response, age at exposure, and length of exposure. Only after completion of such studies can we know the benefits and risks of infant phytoestrogen exposure and thus be able to provide the best advice to parents concerning infant exposures from breast milk and soy- based formulas.
In the meantime, this large, uncon- trolled, and basically unmonitored h u h n infant experiment continues unabated.
R&r F Slauln JL. PhylOestrogens in breast milk-aw
other advantage of breast-feeding? [Editorial] , Clin Chem 1996;42:841-2. 2. h a n k AA. Custer U. Daidzein and genistein
concentrations In human milk after soy con. ' sumptlon. Clin Chem 1996;42:955-64.
3. Collaboralive Group on Hormonal Factors in Breast Cancer. Breast cancer and hormonal
850 Clinical Chemistry 43, No. 5, 1997
contraceptives: collaborative reanalysis of individual dale on 53 297 w m e n with breast cancer and 100 239 women without breast cancer from 54 epidemiological studies. Lan- cet 1996:347:171327.
4. Goddard MK. tionnone replacement therapy and breast cancer, endometrial cancer and carcimascular disease: nSkS and benefits Br 1 Gen Pract 1992:42:120-5.
5. Leopold AS, Ervin M, Browning B. Phytoestro- gens: adverse effects on reproduction in Cali- fornia quail. Science 1976;191.98-100.
6. Shun DA. The effects of piant oestrogens on animal reproduction. Endeavour 1974;35: 110 -3
7. Medbck KL, Branham WS. Sheehan DM. The effects of ohytoestrogens on neonatal rat uter- ine growth and development. Proc Soc Exp BIOI Med 1995:208:307-13.
8. Bern HA, Talamantes F. Neonatal mouse models and their relation to disease in the human female. In: Herbs1 AL. Bern HA. eds. Develop mental effects of diethylstilbestrol (DES) in pregnancy. New York: Thiemebtranon, 1981: 129-47.
9. Ojeda SR, Andrews WW. Advis 1, Sm&h-White 5. Recent advonccs in the endocrinology of pd- berty. Endocr Rev 1980;1:228-57
10. lwine CHG. htzpatrich M, RoberLsori I. Woodhams D. The wtentlal adverse effects of soybean phytoestmgens in infant feeding. N 2 Med J 1995;108:206-9.
Daniel M. Sheehan National Ccnter for Toxrcol. Res.
USFDA
Jcjferson, AR 72079 3900 NCTR R d , HFT-130
To the Editor: The editorial by Slavin 121 surnma- rizes the effects of isoflavones and recent research on human isoflavone exposure, including our studies on breast milk concentrations after soy consumption 121. Some brief comments may be helpful to add to the current knowledge in the area of isoflavonoid research.
Extensive analyses of isoflavone concentrations in legumes showed that exclusively soy foods contained considerable amounts of these agents, whereas other legumes such as lentils, beans, and chickpeas contained trace or nondetectable amounts 131. A recent study con- firmed these results by reporting isoflavone concentrations in lentilb, beans, and chickpeas to be lower by a factor of 50 to 5000 relative to soy- beans (41.
The higher urinary isoflavone rcr- covery after consumption of fcr- rnented vs nonfermented soy foods 151 needs to be verified became the protocol applied resulted in differen-
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c
SIGNIFICANCE OF PEIYTOEmOGmS IN INFANT SOY IFOlXMWLA Confmmce Room 2M2, Building 31, lvlEI Campus
Msy 15,1997 9~00 AM - 4:30 PM
I. Wdcbme and Charge to the GTOUP ........................................... Ephrsrim Y. Levin, M.D.
II. Insroduaion by the Chair .......................................................... Frederick NaftoIin, M.D.
m. FDA Presentadon ..................................................................... 1Ehzht.h A. Ydey, Ph.D,
N. Overview and H[istory ............................................................... Samuel J. Fomon, M,D-
v. plwxnml 'ons ............................................................................ d d S. R
/ PW&a L. Whitten, Ph.D., Emory U6v&ty - Ddopmemal Actions of Is05avinoids in
J' Claude Hughes, M.D., Ph-D., Duke Ilnksity - DeveIopmen.tal lEffects of Dietary Soy
J Doyle Waggle, Protein T&ologies - Soy Protehs for Mmt Formula: Production and
,/Kenneth D.R S & M , Ph.b., Childtan's Hospital Medical Cent#, CinGinnati -
Jkaren 0. Klein, M.D., AI, Dupont Insthxk - Phytoestrogens, Soy Infant Formula, and
Ph.D-, University of Minnesota - EffeGt ofPhytwstrogms on -moms in Adult wmm
Compahon to Endocrine Disrupters
to Endocrine Function Ph.D., Tube Uni-ty - Agonistic and Antagonistic Activities of in Estrogpfi Response systrms
Shaehan, Fh.D., Food and Drug Administration (FDA) - Potential Toxicity of Soy Mbm Formula
VI. Discussion OiftheIssUes (imcluding RFAIRFplother mechanisms and activities)
Gilrnan D. Grave, M-D., "D
VII. Other Industry and Government Representatives and ConsuItants ................
Jeflsey Batan, M.D., "D Dennis M. Bier, M.D., Baylor College of Medicine Michael B o w , Ph.D., 'FDA Robert Bums, Ph.D., Mead Johnson Research Center CbrIotte Cati; M.D., MCHD
R=99%
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t .
ID: 3014~109791
Dada Danford, D.Sc., R.D., FDA Daniel Docrge, Ph.D., IFPA Mr. Robert C. War& Infant Formula Council George P. Giamia, MD., NICHD Linda Ooldeq M.D., FDA Clare M. Hdm, Ph.D., UniverSity of Illinois Marc S. Jacobson, M.D., Committee on Nutrition, American Academy of Pediatrics Susan M. &up, Pb.D., Wyeth-Ayerst Research Tony Huggeq PhD., Nestle Food Company Eiieen Maddeq Ph.D., Nestle Food Company Charles E. Mize, M.D., Ph.D., FDA Ms. Mardi Mountford, Mimt Formula Council Warn R. Obermcyer, Jr., Ph.D., FDA Marge Ostrom, Phx)., Ross Products Division, Abbott Laboratories Jean Temeck, M.D., F'DA John E. Vandewem, Ph.D., FDA Linda Wright, M.D., NXCHD Sumner J- YafCe, M.D., MCRD Ekhard Ziegler, M.D., University ofIowa
PACE 3/7
000258
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SIGiMFICANCE OF PHYTOESXROGENS IN I"T SOY FORMULA
L i v L oiPanmc:pwa~x
Conference Room 2A52, Building 31
May 15,1997
Wane U n i v m 1430 Tulane Avenue
hvironmentaI HeaIth Sciences
JcfEeyBaroq MD. Senior Investigator Developmental Endocrinology Branch National Institute of Child Health and Human Development, NM
9000 Rockville Pike -0.- r'r, 3. * A ROO^ IONAU-;. ~tjttu~>s q t t
Beth& h4D 20892-1862
lknnis M Bier, MD. h.ofessor of Pediatrics Director, Children's Nutrition Research Ctr. Baylor College of MediGine 1100 Bates Street Houston, TX 77030-2600
Michael Bolger, Ph.D. Chief, Contaminant Branch OSce of P l a t and Dairy Foods,
arid Beverages Food and D I U ~ Administration, HIFS-308 200 c street, sw Washington, DC 20204
Robert Burns, PhD- Div- of NeonatoIogy and Phmnacology De@. of Medicine and Clinical Af%h Mead Johnson Research Center 2404 W Llayd Expressway E~anStrin~?, IN 47721-0001
Charlotte Catz, M.D. Chief Pregnancy and PerinatoIogy Branch, CRMC, MCHD, NIH
Room 4B03, Executive Bldg. 6100 6 100 Executive Blvd. MSC 7.5 10 Beth&& MID 20892-75 10
Dada Danford, D.Sc., R.D. D'tremor Division of Science and Applied
Food and Drug Adminismion 206 c7 Steel, sw WWhingld~ x 20284
Technology
DanieI Doerge, PhD. National Cuxter fbr Toxicology Re!searcb 3900 NCTR Road "-1 Room 122, Bldg. 13 Food and Drug &hinigmtion J-II, AR 72079-9502
Samuel J- Fomon, M.D. 4 1 5 Windsor Drive New BraunfbIs, TX 78132
Mr. Robert Gelardi Infknt Formula Council Suite 5000 5775 PeachtreeDunwoody Road Atlanta, GA 30342
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GeorgeP. Giacoi;r: M.D. Special Expert Endocrinology, Nutrition ma Growth Elm&+ CRMC, NCHD, NM
Room 4B 1 1, Executive Bldg. 6 100 6100 Ex#wive Blvd. MSC 7510 Bethesda, MD 20892-7510
Linda Golden, M.D. Medical Reviewer Division of Reproductive Urological
Food and Drug Administration, z.xlFD-580 5600 Fishers Lane Rockville, MD 20857
DrugProducts
Ghan D. Grave, M.D. Chief Endocrinology, Nuwon and Growth
Branch, CRMC, NIcI?D: NM Room 4B 1 1, Executive Bldg. 6 IO0 6100 Executive Blvd. MSC 7510 Bethesda, Mx, 20892-7510
usm;.y Clare M. Mer, Ph.D. Pl-OfkSSX Depamnent of Food Saence
University of Illinois 1302 West Pennsylvania Avenue Urban4 IL 61801
and Human Nutrition
Anthony Huggett, Ph.D. Nestec S.A. Research Center VCTS-C~~Z-L~S-BI~~C Case Postale 44 CH-lo00 Lausannc 26 Switzerland
Claude Hughes, M.D., PLD. A d a t e Professor Dept- of Obstetrics and Gynecology Box 3084 Duke UnivwSity Medical Center Durham, NC 27710
Susan M. Kaup, Ph.D. principd scientist Nutrition Retearch Wyeth NutritionaIt Intcrnationd 145 King of M a Road . Radnor, PA 19087
Karen 0. Kleiq M.D. Pediatric Endocrinologist A.I. Dupont Institute P.0 , Box 269 Wilmington, DE 19899
Ephraim Y. Levin, M.P. Medical Ofiicer Endocrinology, Nutrition and Ckowth
Room 4B 1 1, Executive Bldg. 61 00 6100 Executive Blvd. MSC 751 0 Bethesda, MD 20892-7510
Bran4 CRMC, NICHD, MM:
Eileen Madden, Ph.D. Carnation Nutrition Product Division Nestle Foal Company 800 N Brand Blvd. Glendale, CA 91203
Charles E. Mke, M.D., PhD, Food and Drug Administration 200 c street, sw Washingmn, DC 20204 .
3 0 1 4 8 0 9 7 9 1
00826Q
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Patricia k Murphy, Ph-D. 23 12 Food Suences Building Iowa State University Ames, 'IA 5001 I
Frederick Nafiolin, MD. Professor and Chairman Dept. of Obstetrics and Qynecology Yale University 333 cedar Smet 3 3 9 m New Haven, Cr 06520
William R. Obermeyer, Jr., Ph.D. Food and Drug Administration 200 c street, sw nT."I.; 11 45.dGz~b DC 2 a m
Marge Ostrom, Ph.D. Ross Products Division AbbottlLabo~ries 625 Cleveland Avenue Columbus, OM 43215-1724
Kenneth D.R. Se&heil, Ph-D. Profwor of Pediatrics Children'sHos$taI M e d i d Center Dept. of Clinical Mass Spectrometry 333 Burnett Avenue Cincinnati, OH 45229
Dm&I M. Sheehan, PhD. Research Biologist National Center for Toxkological Research Food and Drug Administration
Jefferson, AEZ 72079 3900 NCTR Road, HFT-130
I D : 30148097Sl PAGE Ei/7
J a m Tanock, M.D. ljladical WCW D i t ~ o n cfiaetaboiic and Endocrine Drug Troducts Food and Drug Administration, M.p-510 5600 Fishers Lane bckville, MD 20857
Louis E. Underwood M.D. CXet Div. of Pediatric E d h d o g y
Unb. of North C a r o h School ofMed. CB M220 509 Burnett-Womack Bldg. Chapel NC 27599-7220
Dept. ofpediatrics
John E. Vandewem, Ph.D. Director Office oiPIant and Daky Foods, and Beverags
EJmd mIg X\fircl Ari.z~.2:-r+-323r, J%&-J; ,~~ 200 C street, 5v washingto$ DC 20204
Doyle H. Waggle, PhD. Vice President and Director 0fTechnoIogy Protein Technologies Xnternational, Inc. Checkerboard Square St. Louis, MO 63 164
PatriciaL. Whittea, PhD. Associate Proftssor Department of Anthropology
Atlanta, GA 30322
Linda Wright, M.D. Special Assistant to the Diractor Center fix Research for Mothers
Room 4B03, Executive Bldg. 6100 6100 Executive Blvd. MSC 75 IO
Emory Unjversiqf
3 0 1 4 8 0 9 7 9 1
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Sumner J. Y e M.D, DitectW Center for Research for Mothers and Children, NICEID. NM Room 43305, ExecutiVe BMg. 6100 6100 Ekcutive Blvd. MSC 7510 ~ethesda, m 20892-75 1 o
J 3 d x t h Yetley, Ph.D. Director Office of Special Nutritionals Food and Drug Administration CFSAN HlFS-450 200 c stleq sw washirl,wn, DC 20204
Ekhard E. Ziegler, M.D. P r o h o r , Dept. of Pediamcs University of Iowa 200 Hawkins Drive, #WI I5 GH
Gq, L+ 52241-;3&3
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TO : From : Certify : Sub j ect : Date: Attached:
smtp[safe tywize@clear .ne t .nz l Linda [email protected] N Electronic copy of ADM GRAS notice Thursday, April 9, 1998 2~ 3:06:04 pm EDT h:\grasnoti\soyisofl\gras.wpf
FD 11111111 11111 Ill Ill1
Valerie A. James Rural Delivery 4 Whangare i New Zealand
Dear Ms. James :
This is in response to your request under the Freedom of Information Act (FOIA) for the submission of Archer Daniels Midland ( A D M ) regarding ADM’s notice to the Food and Drug Administration (FDA) of ADM’s view that the use of soy isoflavones as a micronutrient in food is generally recognized as safe (GRAS). In order to expedite the multiple FOIA requests that FDA has received regarding this notice, ADM has graciously provided an electronic copy of its submission. The electronic copy is in Wnrdl Perfect 5.1. Because I myself was able to retrieve this attachiient using i t s .wpf extension, I am transmittins this electronic copy t q vou in exactly the fsrmat that I received, P f you are *~nablc tc retrieve i t r , i wiii artempt to resend it as a Word document, because the first electronic mail message that I received from your E-mail address included a Word attachment.
*.
Please let me know if you are able to retrieve this copy.
Linda S. Kahl, Ph.D. Regulatory Policy Branch, HFS-206 Office of Premarket Approval Center for Food Safety and Applied Nutrition 200 C St., SW, Washington DC 20204 Phone: (202) 418-3101 Fax: (202) 418-3131 Internet:[email protected]
000228
TO : ISMTP@FDA-OC-T~INING@FDAOC[~safetywize@c~ear.net.~z~1 From : Linda Kahl@[email protected]
Subject: FD l1111111lllll111 Ill1 Certify: N
re: RE: Electronic copy of ADM GRAS notice Date: Friday, April 10, i998 at 8:26:46 am